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Associate Director, Global Project Management - BioPharma

Ansök    Feb 3    Astrazeneca AB    Läkemedelsinspektör
Are you ready to make a meaningful impact on patients' lives through the work you do? We are seeking an Associate Director for our Global Portfolio and Project Management Organization (GPPM). This role is pivotal in advancing our pipeline and delivering Growth Through Innovation by partnering closely with Research & Development (R&D) and business leaders. As the Associate Director of Global Project Management (GPM), you will lead global, cross-functional d... Visa mer
Are you ready to make a meaningful impact on patients' lives through the work you do? We are seeking an Associate Director for our Global Portfolio and Project Management Organization (GPPM). This role is pivotal in advancing our pipeline and delivering Growth Through Innovation by partnering closely with Research & Development (R&D) and business leaders. As the Associate Director of Global Project Management (GPM), you will lead global, cross-functional drug development teams and sub?teams to deliver against strategic objectives and secure significant development, regulatory, and commercial outcomes. Complementing the Global Project Leader, you will provide top?level oversight and integration from development through to commercialization.

This position is based at our Gothenburg site, a vibrant nexus of innovation where more than 2,400 colleagues from 50+ countries collaborate across state?of?the?art laboratories and shared spaces to accelerate decision?making and problem?solving.

Accountabilities

Strategic business partnership

* Provide input into project strategy and vision through expertise in project management and navigation of therapy area and corporate governance processes.
* Ensure alignment of project and operational deliverables with team strategy; share lessons learned and communicate them where relevant.
* Manage or lead elements of the development plan or strategy as delegated by the Global Project Leader.
* Ensure appropriate linkages between project strategy and key internal processes and maintain relevant enterprise systems.
* Collaborate with alliance partners where applicable and partner with Business Development to provide project input to potential deal cases.

Cross?functional team leadership and delivery

* Lead cross?functional drug development teams and sub?teams, ensuring accurate, achievable, and scenario?based project plans.
* Act as a core GPT member, driving effective operation of early and/or late?stage GPTs, including overall plans, priorities, budget, and risk management.
* Build and sustain a cohesive, high?performing team with the Global Project Leader; facilitate decision?making and issue resolution.
* Establish and manage effective team communication processes and proactively ensure robust information management practices.

Governance and investment decisions

* Guide GPTs toward effective governance interactions and lead the development of high?quality investment decision documentation.
* Integrate and synthesize information for teams and senior management/governance bodies to enable efficient decision?making.

Planning, monitoring, and delivery

* Ensure GPT deliverables, budgets, schedules, and performance standards are realistically set, governance?approved, and achieved.
* Maintain plans with the highest data quality and be accountable for all project management deliverables for GPTs and sub?teams.

Entrepreneurship

* Identify and drive opportunities for positive change and barrier removal within and beyond the team.
* Champion company standard processes and apply business knowledge to drive cross?functional and cross?project learning.

Essential skills and experience

* Bachelor's degree with 5+ years' experience supporting cross?functional drug development teams or leading sub?teams.
* Project management experience with a successful track record delivering within agreed time, quality, and cost.
* Proficiency with project management tools and processes.
* Demonstrated ability to lead high?performing teams and establish effective team operations.
* Ability to work effectively with senior collaborators.
* Strong information management skills, including modern collaboration tools (e.g., SharePoint, Microsoft Teams, OneNote).
* Experience ensuring high?quality data in enterprise systems.

Desirable skills and experience

* Advanced degree in a scientific field and/or MBA.
* 7+ years' relevant experience.
* In?depth knowledge of the drug development process, with therapeutic area?specific experience.
* Experience with advanced project management tools (e.g., Planisware/PLANIT).
* Project Management Professional (PMP) certification.

We value the connectivity and pace that in?person collaboration enables. Our hybrid model typically includes a minimum of three days per week on site, with flexibility built in to support individual needs and team delivery.



Why AstraZeneca
At AstraZeneca, we are on a mission to do more and be more. Join us at an exciting time of growth through innovation. We are reimagining how we work, introducing new solutions and technology through investment in automated processes. By driving greater consistency and efficiency, we accelerate our next chapter of growth. Here, every person plays a part in our story. Speak up, take initiative, and make it yours.



Ready to make this role yours? Submit your cover letter and CV by 17th of February. Visa mindre

Quality Advisor

Ansök    Mar 4    Logent AB    Läkemedelsinspektör
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. The arena Are you intere... Visa mer
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. The arena Are you interested in a challenging opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies? The Development Quality function is responsible for quality oversight of the pharmaceutical development activities within AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca’s pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase We have an exciting opportunity for a 12 months temporary assignment as Quality Advisor, in the Site Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains. This is a great opportunity for you who are strong in quality and like to work close to development, Good Manufacturing Practice and making sure quality is assured when delivering new products The role Working in the Site Quality team means you will work closely with the internal assets/facilities, teaming up with the pharmaceutical development functions and be involved in cross business processes. To build strong relationships with these functions knowing their business is key, to give support to projects and develop ways of working that builds for success. The ability to interpret and trend compliance data to measure and improve quality standards is key. You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. Whilst taking on your own specialist areas and making good quality decisions, you will be encouraged to think strategically and use your problem solving skills to resolve any quality issues. You will participate and contribute to continuous improvement projects with the aim to standardize and simplify our internal processes. Typical Accountabilities: • Responsible for quality release of manufactured Drug Product, Investigational Medicinal Product for clinical trials • Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects related to drug product • Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards • Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working Minimum requirements – Education and Experience • MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment • Demonstrates understanding of international quality systems regulations, concepts, industry practices to adopt best in class processes • A comprehensive understanding of GMP regulations, the pharmaceutical development process and supply chain process would be advantageous • Experience of interacting effectively across interfaces collaborating internally in a good communicative way • Fluent in written and spoken English Required soft skills: • Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude • Excellent team working and networking skills and encourages team effectiveness • A good communicator with experience of interacting effectively across interfaces collaborating internally About AstraZeneca Gothenburg Hub Our stunning campus in Gothenburg is one of AstraZeneca’s three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve built a series of environments where innovation can happen.
This is a consultancy assignment at AstraZeneca, and during the assignment, you will be employed by Logent. Visa mindre

Associate Director Validation, site Quality

Ansök    Mar 3    Logent AB    Läkemedelsinspektör
Join us in our Site Quality Team! We provide Quality oversight in the development of Investigational products and have the responsibility for Licence to Operate at our development site and play an important part in the commercialisation of new medicines. Development Quality is a Global group, with teams located in Gothenburg (Sweden), Macclesfield, (UK) and Durham (North Carolina, US). With a portfolio encompassing both small and large molecules, combinati... Visa mer
Join us in our Site Quality Team! We provide Quality oversight in the development of Investigational products and have the responsibility for Licence to Operate at our development site and play an important part in the commercialisation of new medicines. Development Quality is a Global group, with teams located in Gothenburg (Sweden), Macclesfield, (UK) and Durham (North Carolina, US). With a portfolio encompassing both small and large molecules, combination products and ground breaking technologies you will be a part of providing novel life-changing medicines to our patients around the globe. Are you ready to take the lead in ensuring patient safety and maintaining License to Operate across our Development functions? As an Associate Director in Site Quality, you will be the prime source for quality/compliance advise in validation activities and provide quality leadership to Development functions. You will interpret AZ regulatory and GMP standards into appropriate quality standards and provide guidance to ensure AstraZeneca and Regulatory requirements are met. The role requires independent operation, risk management and lean skills, and decision-making against a background of varying regulations and standards. Your responsibility will extend to internal assets and GMP compliance decisions, having a major impact on AZ’s business. Your role As an Associate Director, you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to your area. You will mentor and support junior colleagues, build strong customer relationships, and participate in GxP audits/initiatives. You will also be responsible for developing and approving GMP documentation and QA risk assessments, providing Quality input into business improvement projects, and be part of external Regulatory Authority GMP inspections. You will work closely with the leadership teams of our customers to set strategic direction for quality within that area, maintaining quality oversight and driving continuous improvement. Most appreciated in the role is the ability to lead projects, to improve processes or ways of working and support different functions with your subject matter expert knowledge. Working in a development environment makes your role versified and enables lifelong learning in everyday tasks. Essential for the role: • Appropriate scientific degree with extensive experience (5-10 years) of working with validation, in a pharmaceutical GMP environment, preferably within a pharmaceutical development organization • Extensive experience from working with all types of validation including, equipment, automation and IT system. • A broad and comprehensive understanding of Quality Systems and GMP and good knowledge and reputation in the QA arena and specifically in GMP matters • A comprehensive understanding of the pharmaceutical/drug development process is essential. A detailed scientific understanding of the Product types being supported is desirable • Experienced in leading projects, making decisions, acting courageously and communicating with conviction and inspiration and in building excellent relationships both internally and with external suppliers or service providers • Understanding of Supply Chain processes is desirable Soft skills: •You thrive when you work independently, when leading projects and take pride in structuring your day, knowing that the diverse workload can change the schedule with little notice. • You are a problem solver who can look at solutions in a pragmatic way – coming up with creative solutions whilst still following our strict regulations. • Excellent team working and networking skills • Demonstrates independent judgement and uses risk management in complex situations • Capable of making decisions, acting courageously and communicating with conviction and inspiration • Demands excellence (sets high bar) and delivers • A good communicator with experience of interacting effectively across interfaces Why AstraZeneca At AstraZeneca, we take Quality seriously. Our work is important, valued, and at the forefront of discovery, development, and commercialization. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and driven by our ambition to go far. We are a team of ambitious people who want to achieve. We work together as a team, get our pipeline out to patients sustainably, reliably, and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca. Make a difference! Apply now and join us in our journey to push the boundaries of science and make a real-life difference to patients. About AstraZeneca Gothenburg Hub Our stunning campus in Gothenburg is one of AstraZeneca’s three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve built a series of environments where innovation can happen. This is a consultancy assignment, and during the assignment, you will be employed by Logent. Visa mindre

Associate Director R&D Procurement

Ansök    Feb 19    Hays AB    Läkemedelsinspektör
Associate Director R&D Procurement - AstraZeneca - Gothenburg - 9-month consultancy assignment Do you have a passion for Procurement? Would you like to join an award-winning procurement team supporting R&D in one of the world's leading pharmaceutical companies? If you thrive in an environment of innovation and change in a fast-growing organisation, then this could be the role for you. AstraZeneca is a global, science-led, patient-focused biopharmaceutica... Visa mer
Associate Director R&D Procurement - AstraZeneca - Gothenburg - 9-month consultancy assignment

Do you have a passion for Procurement? Would you like to join an award-winning procurement team supporting R&D in one of the world's leading pharmaceutical companies? If you thrive in an environment of innovation and change in a fast-growing organisation, then this could be the role for you.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focusses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases.

Introduction to role:
Join us at AstraZeneca, a place that champions knowledge-sharing, ambitious thinking, and innovation. We are looking for an integral member to join our Research & Development (R&D) Procurement team. This role has a global remit, and you will have accountability for a category in the R&D space.

The role focusses on the development and deployment of global category strategies and initiatives, leading our major supplier relationships, developing deeper relationships with the various stakeholder groups through effective business partnering, and ensuring that the underpinning process improvement and procurement activities deliver the expected business value.

Accountabilities:
In this role, you will be responsible for developing long-term strategic plans for an entire spending category within AstraZeneca. You will manage stakeholder and supplier relationships to ensure that category strategies are highly aligned to current and future business needs and that the supply base is capable of supporting these strategies.

You will lead project initiatives tied to the category strategies to deliver value to the business, lead the implementation of sustainability initiatives with vendors, and lead complex contractual and commercial negotiations.

You will work alongside key stakeholders and align with GPS (Global Procurement Services). You will ensure a data-driven approach to category management and high-quality analytics to deliver insights, capabilities, and results.

Typical Responsibilities:
* Lead implementation of category plans to ensure that the underpinning process improvement and procurement activities deliver business value in accordance with the strategic plan and help towards our Sustainability targets.
* Develop long term strategic plans for an agreed scope of spend area, with a focus on delivering broader value, innovation, and savings.
* Support the team in strategic relationship management (customer and supplier) - ensuring Category Strategies are fully aligned to current and future Business needs, and we maintain a supply base capable of supporting these strategies.
* Work alongside Global Procurement Services (GPS) advising on and driving procurement strategies to make decisions necessary to make purchases in congruence with organisational objectives.
* Advise on contracts and agreements for the supply of sophisticated products and services with new and existing suppliers
* Cross functionally supports Global procurement colleagues and collaborates on setting up and completing the strategy.

Essential Requirements:
* Bachelor's degree or equivalent
* Significant experience in a procurement environment
* Significant experience in Category Management (preferably in R&D/Pharma)
* Project management and change management
* Good solid understanding of the research environment
* Strong communication skills and ability to influence others
* Comfort with risk and ambiguous situations

Desirable:
* People leadership skills

What's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. Visa mindre

Drug Product Delivery Operator | AstraZeneca | Göteborg

AstraZeneca söker nu en engagerad Drug Product Delivery Operator till sitt team i Göteborg för en operativ roll inom läkemedelsdistribution och materialhantering. Här får du möjligheten att arbeta i en dynamisk miljö där vetenskap och innovation möts för att förbättra patienters liv. Är du strukturerad, lösningsorienterad och redo att bidra till banbrytande läkemedelsutveckling? Då kan denna roll vara något för dig! Kort om uppdraget • Placeringsort: Möl... Visa mer
AstraZeneca söker nu en engagerad Drug Product Delivery Operator till sitt team i Göteborg för en operativ roll inom läkemedelsdistribution och materialhantering. Här får du möjligheten att arbeta i en dynamisk miljö där vetenskap och innovation möts för att förbättra patienters liv. Är du strukturerad, lösningsorienterad och redo att bidra till banbrytande läkemedelsutveckling? Då kan denna roll vara något för dig!

Kort om uppdraget

• Placeringsort: Mölndal
• Typ av tjänst: konsultuppdrag
• Uppdragslängd: 2024-12-02 till 2025-09-30 med goda möjligheter till förlängning

Om rollen

Inom AstraZenecas enhet för Drug Product Delivery (DPD) ansvarar avdelningen för att packa, märka och distribuera prövningsläkemedel till kliniska studier. DPD hanterar både lanserade produkter och läkemedel under utveckling för olika terapiområden, och arbetar i en snabbföränderlig miljö där flexibilitet och anpassningsförmåga är avgörande för att stötta tidiga kliniska faser.

DPD Operator kommer att ha en operativ roll inom Distribution eller Materialhantering – två av DPD fokusområden. I denna roll utförs och dokumenteras arbetsuppgifter enligt etablerade procedurer i en komplex och reglerad GMP-miljö, och operatören förväntas bidra till förbättringar av interna processer. Ansvarsområden inkluderar att förbereda dokumentation, ta emot och packa prövningsläkemedel samt att vara kontaktperson för distributionsfrågor inom ett antal studier.

Kvalifikationer

För att passa i rollen ser vi gärna att du har:

• BSc/MSc inom kemi, farmaci, ingenjörsvetenskap, logistik eller liknande, eller motsvarande erfarenhet.
• Minst två års erfarenhet inom Supply Chain och läkemedelsutveckling för att kunna bidra till en effektiv leveranskedjeorganisation.
• Läkemedelskunskap inklusive hantering av artiklar/produkter och serie-/batchhantering.
• Förmåga att arbeta i team i en kulturellt diversifierad, komplex och föränderlig miljö, främst internt men även externt.
• Goda kunskaper i engelska, både muntligt och skriftligt.

Meriterande:

• Förståelse för principer och tillämpningar av SHE och GMP i en FoU-miljö.

Varför AstraZeneca?

AstraZeneca är ett av världens mest spännande biofarmaceutiska företag. Från forskare till laboratorietekniker och säljare – alla på AstraZeneca delar en passion för att förbättra patienters liv och bidra till samhället. Företaget söker personer som delar detta engagemang och har drivkraften att möta behoven hos patienter världen över.

Hur du ansöker

För att söka tjänsten klickar du på "Sök tjänsten" ovan och fyller i formuläret. Vänligen kontakta rekryterare Oscar Sahlin via telefonnummer 072-204 84 03 om du har några frågor eller funderingar.

Vi intervjuar löpande, så skicka in din ansökan så snart som möjligt!

Forma framtiden med oss!

Lernia utvecklar framtidens arbetskraft. Det gör vi genom att utbilda, matcha, bemanna och rekrytera. Snabbt och utan krångel löser vi arbetsmarknadens behov så att människor och företag kan nå sin fulla potential. Det har varit vår uppgift i över hundra år. Lernia omsatte 3,5 miljarder kronor 2023 och finns över hela landet. Vi utbildade och coachade 18 400 personer och förmedlade 10 900 bemanningskonsulter. 12 000 personer fick möjlighet till nytt jobb genom våra tjänster. Läs mer på lernia.se Visa mindre

Clinical Evidence Specialist

Clinical Evidence Specialist If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose. Mölnlycke is looking for a Cli... Visa mer
Clinical Evidence Specialist
If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose.
Mölnlycke is looking for a Clinical Evidence Specialist to play a crucial role in executing Clinical Evaluations, PMCF planning and providing clinical perspective input to cross-functional teams in new product development and life cycle management for Mölnlycke´s medical devices.
In this job you will be based at our headquarters in Gothenburg and very soon at our new office at GoCo Health Innovation City, a world-class innovation cluster for health!

About the job
This is a great opportunity to contribute to our product development process and life management activities with regards to clinical evidence and PMCF input (Clinical Evaluation Plans, Clinical Evaluation Reports and PMCF documentation).


These are the main accountabilities for this position
Grow your career in an international environment! In this position you’ll provide clinical evidence knowledge and input for Mölnlycke´s medical devices.
You’ll work cross-functionally and provide relevant clinical input to project development projects and life cycle management activities.
You’ll be the SME for clinical evidence input to the technical documentation for assigned products.
You’ll search, review and appraise clinical literature and information specifically applicable to clinical performance and safety of Mölnlycke´s medical devices.
You’ll provide input to Post Market Follow-up strategies for Mölnlycke´s medical devices .
You’ll evaluate clinical evidence to support clinical performance and safety including support for Claims and Marketing messages.
You’ll provide support and be the SME for Clinical Evaluations and PMCF during internal and external audits.

What you’ll need
In this role we would like you to have the following capabilities, qualifications and experience:
PhD (in relevant medical/scientific area) OR Relevant medical/scientific degree + 5 years´ relevant experience in the medical device industry OR + 10 years´ relevant experience in the medical device industry.
Experience from Medical Device or Pharmaceutical Industry preferably within Clinical Research/Clinical Evaluations.
Analytical thinking and scientific mindset, knowledge in MDR, relevant MDCG guidance documents and MEDDEV standards for Clinical Evaluations and PMCF.
Experience in systematic literature search strategies, critical appraisal of clinical studies,, proficient scientific writing and with a digitalization mindset.
To be successful in this role you'll need to have the ability to act in a transparent and consistent manner while driving results, be a problem solver and solution-oriented with evidence of risk-adjusted decision making and to have good networking and organizational skills as well as sense of ownership and execution. You'll need to be a strong team player who can manage multiple and diverse stakeholders and to have strong and clear communication skills utilized to reach decisions that balance a diverse set of needs.
You’ll need to be fluent in English (both written and spoken).

What you’ll get
Wellness benefits
Flexible working hours
Great colleagues in a global company
An open, friendly and fair working atmosphere
Competitive compensation package including company pension plan, bonus, company health care



Our approach to diversity and inclusion
At Mölnlycke diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity and problem-solving. We invite you to be a part of a team where authenticity is embraced, and every employee, regardless of background or any other traits, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role.

About Mölnlycke
Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organized in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.
Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health, and in early 2025 our headquarters will move there. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916.
For more information, please visit www.molnlycke.com and www.molnlycke.com/careers
If this sounds like you and you feel you have what it takes to succeed in this role, we want to hear from you as soon as possible. Visa mindre

Clinical Project Manager to Antaros Medical

Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading. At Antaros Medical, we are pioneering imagin... Visa mer
Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading.

At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development.

We value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We have currently around 125 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.

As a part of our growth journey, we are looking for our next Clinical Project Manager with experience in clinical drug development. You will ideally join our office in Mölndal, Uppsala or Malmö in Sweden, and partly be able to work from home.

As a Clinical Project Manager at Antaros Medical, you will be overall responsible and accountable for project management of the imaging part in clinical trials, from initiation to end of assigned projects. Your responsibility includes to ensure the projects are delivered accordingly with timelines, to the agreed budget, with high quality, and per internal and client’s SOPs, ICH/GCP and other regulation.

Your main responsibilities will be:

- Manage multiple projects ranging in size and complexity, from single to multicenter studies

- Act as a primary contact to the client to ensure smooth operations and communication

- Manage the internal trial team to ensure the right input at the right time from different skills within the company

- Present project information at internal and external meetings

- Risk management responsibility and lessons learned for assigned projects

- Manage the project financials in collaboration with the Finance Department and financial follow-up for assigned projects

Who are we looking for?

We believe that you have demonstrated collaboration skills as well as a team-oriented approach to engage with colleagues and clients. You have the flexibility and the ability to handle multiple tasks and projects to meet deadlines while delivering high-quality work in a dynamic environment.

As a person, we further believe that you are outgoing and enthusiastic, a natural communicator, and can adapt your approach depending on the situation. You work as a team player and apply communicative and interactive skills on different levels within the organization and with external parties and customers.

Requirements:

- University degree within the Life Science field

- At least 3 years’ experience from working with clinical trials from start to end of projects, including experience within project management of clinical trials

- Strong understanding of ICH-GCP and other relevant regulations and guidelines in relation to clinical trials

- Understanding of the full drug development process

- Excellent written and verbal communication skills in English

Are you interested?

Great to hear! Please submit your application via this link with a short personal letter and your CV included, no later than February 12th, 2023.

Please attach degree certificates from higher level education(s) together with your application.

For more information about the position, please contact Emilia Larsson, HR department, at +46 73-728 93 43, or [email protected]

We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.

About Antaros Medical

At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialised in cardiorenal & metabolic diseases and oncology. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI) and COST.

Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden, and we have recently opened a subsidiary in the US. If you want to find out more about our company, go to our website: www.antarosmedical.com (http://www.antarosmedical.com/)

Our culture is our people, and our values make us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even more: Our culture - Antaros Medical (https://antarosmedical.com/our-culture/) Visa mindre

Business Development Manager

Ansök    Okt 19    Astrazeneca AB    Läkemedelsinspektör
Are you a Lean person with extensive experience in Change Management and a genuine passion for service? Can you envision yourself in a position where your skills and personality will have a profound impact on the business efficiency? Then we have an exciting opportunity for you at AstraZeneca in Gothenburg. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of pr... Visa mer
Are you a Lean person with extensive experience in Change Management and a genuine passion for service? Can you envision yourself in a position where your skills and personality will have a profound impact on the business efficiency? Then we have an exciting opportunity for you at AstraZeneca in Gothenburg.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

We are now recruiting a dedicated Business Development Manager to our Scientific Services team, within Facilities Management (FM). In your role you will get the opportunity to work across multiple services lines and support the organisation at a significant number of levels. Our remit is to provide laboratory support and comprehensive laboratory equipment technical support. Your main responsibility will be to enable, influence and drive continuous improvement projects across our deliveries on both a tactical as well as operational level.

What you'll do
In your position as Business Development Manager your focus will be supporting the Scientific Services team and the different functions across FM with emphasis on improving Business Performance and processes by driving Change Management and Innovation projects across service lines, including sustainability initiatives. You will work with performance and innovation tracking, LEAN and development of a Continuous Improvement culture across all levels within FM functions. The job also means to benchmark against other FM organisations to identify areas for improvements. You will be part of the FM Extended Leadership Team, owning the FM Business Plan, and be accountable for shaping and communicating the long-term FM strategy.

We will rely on you to:

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Deliver excellence in Change Management and Improvement projects
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Assure improvement initiatives deliver in time and to project benefits (Lead/Facilitator)
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Lead and ensure delivery of improvement projects across Facilities Managements including supply partners.
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Implement and communicate changes resulting from development projects/programmes together with the business
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Optimise services by working across FM, other AstraZeneca functions and third-party supply partners
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Be accountable for FM Lean strategy, methodology and processes including Lean Mentoring.
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Drive strategy for improved Lean practice within FM Gothenburg
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Develop and offer Lean training packages for One FM

An important part of the role is to create staff engagement around our FM Delivery and Strategic Targets and to drive the strategy for Customer Satisfaction measurement.

Essential for the role
To be successful in this position, your service delivery mindset, and a phenomenal ability to manage partners, customers and suppliers are essential. Your interpersonal and communication skills are of great importance in this role. You love interactions and are truly passionate about understanding your customers' views and needs. This requires you to have a balance between detail focus and critical thinking, combined with an analytical mindset.

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Talented Improvement Project Management skills
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Proven track record in shaping and communicating long term FM strategy
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Extensive experience in managing and delivering Change Management programs
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Black Belt Lean Qualification
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Experience from Facility Management industry or laboratories
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Knowledge of the operational needs of pharmaceutical business
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Fluent in Swedish and English


Why AstraZeneca?
At AstraZeneca, we 're dedicated to being a Great Place to Work. You will be empowered to push the boundaries of science and fuel your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures, collaboration, openness and innovation.

We offer competitive salaries and excellent benefits, such as extra paid Holiday, Private Medical Benefit, on-site Work Out and much, much more.

So, what's next?
If you're curious to know more then please reach out to Lars Stålhult (+46 705-761252). We welcome your application, no later than November 3rd.

Where can I find out more?

AstraZeneca in Sweden - https://careers.astrazeneca.com/sweden

Inclusion and Diversity at AstraZeneca - https://careers.astrazeneca.com/inclusion-diversity Visa mindre

Project Manager - Document & Unified Clinical System

Ansök    Sep 4    Astrazeneca AB    Läkemedelsinspektör
Are you a Project Manager with background in the pharmaceutical industry? Do you have knowledge of clinical study information and enjoy working collaboratively and empower people around you? If yes, AstraZeneca might have the job for you! We are now looking for a Project Manager - Document & Unified Clinical System that will lead both process and technology improvements to enable end-to-end delivery of clinical studies and/or support projects relating to... Visa mer
Are you a Project Manager with background in the pharmaceutical industry? Do you have knowledge of clinical study information and enjoy working collaboratively and empower people around you? If yes, AstraZeneca might have the job for you!

We are now looking for a Project Manager - Document & Unified Clinical System that will lead both process and technology improvements to enable end-to-end delivery of clinical studies and/or support projects relating to document and operational trial management for Mergers and Acquisitions. The position can be based either in Gothenburg (Sweden), Warsaw (Poland) or Cambridge (UK).

In this role you will be a member of the Global Clinical Solutions department in the Development Operations organisation. Global Clinical Solutions drives the delivery of Business Process Excellence and Technology for the Development Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external partnerships.

The Development Operations organisation brings together all the skills groups to drive critical operational activities for early and late stage medicines development. We have deep and specialist expertise in study and site & data management, technical systems and processes, and in working with CROs and partner organisations to ensure the best delivery of our clinical trials in countries around the world.

What you'll do:
As Project Manager you will operate in a global setting, driving efficient operation of project teams including overall plans, priorities, budget and risk management. It's your responsibility to build an efficient and high-performing team environment and lead the team towards the right activities at the right time, aligned with coordinated project plan. You will also champion best practice methodology in project management and use business knowledge to drive cross functional and cross-project learning. The role is a is a member of Global Clinical Solutions department in Development Operations and will be a member of the extended leadership team in Document & Unified Clinical System sub-function.

Other responsibilities:

* Provide input into the project strategy & vision through expertise in project management, execution and governance
* Proactively use change management plans and methodology to seek opportunities to drive positive change and remove barriers within and outside the team.
* Contribute to or lead specific aspects of preparing for governance interactions and navigate teams through governance and key processes
* Manage risk including assessment and mitigation planning
* Understand the processes, technology and services the clinical study team relies on and use this knowledge to provide advice and mentorship, removes barriers, provides solutions and sees opportunities for improvement
* Provides guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.

Essential for the role:

* Bachelor's of Science in an appropriate field or equivalent experience.
* Extensive experience in Drug Development within a pharmaceutical or clinical background.
* High level of business process, technology and Clinical Study information knowledge.
* Demonstrated project management skills and proven skills to deliver to time, cost and quality.
* Ability to collaborate, motivate and empower others to accomplish individual, team and organizational objectives.

Desirable for the role:

* Comprehensive knowledge of ICH/GCP.
* Experience in Validation of computerized systems in a regulated environment - preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX etc.) requirements.
* Great knowledge of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.

We also see that the successful candidate has experience in working collaboratively with external partners and you have skills in the field of mentoring, problem solving and interpersonal skills. As well as demonstrate great written and verbal communication in English.

Why AstraZeneca?
When we see an opportunity for change, we seize it and make it happen, because any opportunity can be start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey in finding new ways to work, pioneering cutting edge methods and bringing unexpected teams together!

Does this sound like your next challenge? Apply today!

We look forward to you application no later than 20th September, 2020.

For more information about the position, please reach out to Hiring Manager Per Garplid at [email protected]. Visa mindre

Clinical Project Manager to Antaros Medical

Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading. At Antaros Medical, we are pioneering imagin... Visa mer
Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading.

At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development.

We value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We have currently around 120 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.

As a part of our growth journey, we are looking for our next Clinical Project Manager with experience in clinical drug development. You will ideally join our office in Mölndal, Uppsala or Malmö in Sweden, and partly be able to work from home.

As a Clinical Project Manager at Antaros Medical, you will be overall responsible and accountable for project management of the imaging part in clinical trials, from initiation to end of assigned projects. Your responsibility includes to ensure the projects are delivered accordingly with timelines, to the agreed budget, with high quality, and per internal and client’s SOPs, ICH/GCP and other regulation.

Your main responsibilities will be:

- Manage multiple projects ranging in size and complexity, from single to multicenter studies

- Act as a primary contact to the client to ensure smooth operations and communication

- Manage the internal trial team to ensure the right input at the right time from different skills within the company

- Present project information at internal and external meetings

- Risk management responsibility and lessons learned for assigned projects

- Manage the project financials in collaboration with the Finance Department and financial follow-up for assigned projects

Who are we looking for?

We believe that you have demonstrated collaboration skills as well as a team-oriented approach to engage with colleagues and clients. You have the flexibility and the ability to handle multiple tasks and projects to meet deadlines while delivering high-quality work in a dynamic environment.

As a person, we further believe that you are outgoing and enthusiastic, a natural communicator, and can adapt your approach depending on the situation. You work as a team player and apply communicative and interactive skills on different levels within the organization and with external parties and customers.

Requirements:

- University degree in Life Science

- At least 3 years’ experience from working with clinical trials from start to end of projects

- Experience within project management of clinical trials is meritorious

- Strong understanding of ICH-GCP and other relevant regulations and guidelines in relation to clinical trials

- Understanding of the full drug development process

- Excellent written and verbal communication skills in English

Are you interested?

Great to hear! Please submit your application via this link with a short personal letter and your CV included, no later than January 15th, 2023.

Please attach degree certificates from higher level education(s) together with your application.

For more information about the position, please contact Emilia Larsson, Junior HR Business Partner, +46 73 728 9343 or [email protected]

We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.

About Antaros Medical

At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialised in cardiorenal & metabolic diseases and oncology. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI) and COST.

Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden, and we have recently opened a subsidiary in the US. If you want to find out more about our company, go to our website: www.antarosmedical.com (http://www.antarosmedical.com/)

Our culture is our people, and our values make us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even more: Our culture - Antaros Medical (https://antarosmedical.com/our-culture/) Visa mindre

Clinical Project Manager to Antaros Medical

Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading. At Antaros Medical, we are pioneering imagin... Visa mer
Would you like to work as a Clinical Project Manager in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? Do you enjoy reaching goals in a fast-paced environment through teamwork and collaboration? If this ticks your boxes, you should continue reading.

At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development.

We value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We have currently around 120 employees working at our offices in Sweden in Mölndal, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.

As a part of our growth journey, we are looking for our next Clinical Project Manager with experience in clinical drug development. You will ideally join our office in Mölndal, Uppsala or Malmö in Sweden, and partly be able to work from home.

As a Clinical Project Manager at Antaros Medical, you will be overall responsible and accountable for project management of the imaging part in clinical trials, from initiation to end of assigned projects. Your responsibility includes to ensure the projects are delivered accordingly with timelines, to the agreed budget, with high quality, and per internal and client’s SOPs, ICH/GCP and other regulation.

Your main responsibilities will be:

- Manage multiple projects ranging in size and complexity, from single to multicenter studies
- Act as a primary contact to the client to ensure smooth operations and communication
- Manage the internal trial team to ensure the right input at the right time from different skills within the company
- Present project information at internal and external meetings
- Risk management responsibility and lessons learned for assigned projects
- Manage the project financials in collaboration with the Finance Department and financial follow-up for assigned projects


Who are we looking for?

We believe that you have demonstrated collaboration skills as well as a team-oriented approach to engage with colleagues and clients. You have the flexibility and the ability to handle multiple tasks and projects to meet deadlines while delivering high-quality work in a dynamic environment.

As a person, we further believe that you are outgoing and enthusiastic, a natural communicator, and can adapt your approach depending on the situation. You work as a team player and apply communicative and interactive skills on different levels within the organization and with external parties and customers.

Requirements:

- University degree in Life Science
- At least 3 years’ experience from working with clinical trials from start to end of projects
- Experience within project management of clinical trials is meritorious
- Strong understanding of ICH-GCP and other relevant regulations and guidelines in relation to clinical trials
- Understanding of the full drug development process
- Excellent written and verbal communication skills in English


Are you interested?

Great to hear! Please submit your application via this link with a short personal letter and your CV included, no later than November 30th, 2022.

Please attach degree certificates from higher level education(s) together with your application.

For more information about the position, please contact Carin Tervald, Head of Clinical Operations, at +46 76 111 07 11, or [email protected]

We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.

About Antaros Medical

At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialised in cardiorenal & metabolic diseases and oncology. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI) and COST.

Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden, and we have recently opened a subsidiary in the US. If you want to find out more about our company, go to our website: www.antarosmedical.com (http://www.antarosmedical.com/)

Our culture is our people, and our values make us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even more: Our culture - Antaros Medical (https://antarosmedical.com/our-culture/) Visa mindre

Operational Technologists to AstraZeneca

Ansök    Jun 11    Randstad AB    Läkemedelsinspektör
Job description Drug Product Manufacture (DPM) in Mölndal manufactures investigational products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers) to AZ clinical studies mainly in phase I/II around the globe and is a vital part of the Pharmaceutical Development Supply Chain organisation. At DPM in the GMP (Good Manufacturing Practice) arena you will make a contribution in delivering clinical results and new medicines. Respons... Visa mer
Job description
Drug Product Manufacture (DPM) in Mölndal manufactures investigational products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers) to AZ clinical studies mainly in phase I/II around the globe and is a vital part of the Pharmaceutical Development Supply Chain organisation. At DPM in the GMP (Good Manufacturing Practice) arena you will make a contribution in delivering clinical results and new medicines.

Responsibilities
You will have a great opportunity to learn more about pharmaceutical development working with experienced operators. This role contributes to the manufacturing of drug product in development phase for clinical studies. All below activities will have an impact on the speed, quality and cost of the AZ development portfolio.

Practical hands-on work in our pilot plant GMP facilities with dedicated tasks in close collaboration and to support DPM Scientist or Senior Scientist e.g. assisting GMP operators with:

• Preparation of process rooms before and after clinical manufacture
• Assembly / disassembly and cleaning of equipment
• Dispensing of API (Active Pharmaceutical Ingredients) and excipients (inactive pharmaceutical ingredients)
• Bulk packing
• Visual inspection of drug products
• Metal check of drug products
• Check of log books
• Working according to SHE (Safety Health and environment) and GMP standards

The role holder will not become fully qualified as a GMP operator but will be able to carry out much of the work expected from operators under supervision.

Qualifications
We are looking for flexible staff (temporary positions) with good team working skills. You need to be careful with the faculty of following written procedures and document executed tasks. In addition, you should have an interest in science, technique and manufacturing equipment and practical hands-on work.

You must have completed your studies at upper secondary school level e.g. in natural/technical sciences.

Application
Application deadline: 2020-06-19, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Emma Johansson, consultant manager, [email protected] or Eleonor Ehrman, consultant manager, +4673-343 41 09.

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

QA med inriktning mot auditering

Ansök    Feb 7    APL    Läkemedelsinspektör
APL, Apotek Produktion & Laboratorier AB, är en av Europas största tillverkare av extemporeläkemedel. APL är också en ledande kontraktstillverkare inom Life Science i Skandinavien med resurser för utveckling, tillverkning och analys av läkemedel. APLs 489 medarbetare är verksamma vid fyra produktionsanläggningar runt om i Sverige samt vid beredningsenheter i anslutning till sjukhus. APL har till uppgift att tillverka extemporeläkemedel som skräddarsys för ... Visa mer
APL, Apotek Produktion & Laboratorier AB, är en av Europas största tillverkare av extemporeläkemedel. APL är också en ledande kontraktstillverkare inom Life Science i Skandinavien med resurser för utveckling, tillverkning och analys av läkemedel. APLs 489 medarbetare är verksamma vid fyra produktionsanläggningar runt om i Sverige samt vid beredningsenheter i anslutning till sjukhus. APL har till uppgift att tillverka extemporeläkemedel som skräddarsys för den enskilde patienten. Många beredningar görs till barn och till patienter med olika typer av överkänslighet. APL bidrar till läkemedel som förbättrar och räddar liv. Läs gärna mer på www.apl.se (http://www.apl.se/)

Har du erfarenhet av att arbeta som auditör inom läkemedelsindustrin? Eller har du erfarenhet som auditör inom närliggande verksamhet så som medicinteknik? Har du erfarenhet av GMP? Vill du arbeta självständigt med kvalitetssäkring på ett spännande företag under stark utveckling?

Tjänsten

Tjänsten är placerad inom Supplier QA som är organiserad under enheten QA & Compliance.

Som QA inom SQA på Apotek Produktion och Laboratorier (APL) kommer du genom ditt kvalitetsarbete med APLs tillverkare och leverantörer att bidra till organisationens övergripande ansvar att förse APL med insatsmaterial (råvaror så som API:er, hjälpämnen och förpackningsmaterial) till läkemedelstillverkning till rätt kvalitet. Fokus ligger på auditering av APLs tillverkare av insatsmaterial och tjänsteleverantörer för att verifiera att de uppfyller kvalitetskraven så som GMP och ISO-krav.

Huvudsakliga arbetsuppgiften:

- Auditering av tillverkare och tjänsteleverantörer. Att självständigt boka och genomföra audits hos tillverkare och tjänsteleverantörer.
- Planera och rapportera audits inom anvisad tid.
- Ta in korrigerande åtgärder från tillverkare och tjänsteleverantörer, bedöma dem och komma med förslag till förbättringar.
- Samarbeta med övriga inom SQA-gruppen som arbetar med leverantörsbedömning, med Inköpsavdelningen med fler funktioner inom företaget.
- Skapa relationer, bedöma och kvalitetssäkra APLs tillverkare och leverantörer i supply-kejdan.
- Aktivt delta i och driva ständigt förbättringsarbete av kvalitetssystem och processer inom SQA.
- QA-representant i interna projekt.


Med frihet under ansvar förväntas du själv planera dina audits och resor. För att lyckas i tjänsten är det nödvändigt att du har möjlighet att vara på resande fot ca 80 resdagar per år och resa till både Europa, Asien och USA. Tjänsten kan på sikt även komma att inkludera interninspektioner.

Tjänsten är placerad i Göteborg, men placering i Malmö kan vara möjligt, tjänsten är på heltid, tillsvidare, med start efter överenskommelse.

Kvalifikationer:

Du är högskoleutbildad inom kemi/läkemedelstillverkning/farmaci. Alternativt har du flerårig erfarenhet inom läkemedelsindustrin. Erfarenhet av auditering är meriterande.

Du har god teknisk kunskap och förståelse för tillverkningsprocesser och behärskar både ISO och GMP-krav som ställs på läkemedelstillverkning.

Tjänsten innefattar en del resande till tillverkare/leverantörer främst i Europa, Asien och USA. Detta ställer höga krav på din förmåga att kommunicera både på svenska och engelska samt att du har en förmåga att skapa goda relationer.

Som person är du självgående och drivande. Du har lätt för att förstå tekniska lösningar och dra slutsatser. Du är bekväm med att fatta snabba beslut och brinner för att utveckla den egna verksamheten samtidigt som du har ett helhetstänk och kan se konsekvenser även utanför det egna området.

Sista ansökningsdag: 2020-02-28

För mer information, kontakta Caroline Ericsson Kvalitetschef Supplier QA. Tfn 010-496 88 61 Mobil 073-868 27 00, [email protected] Visa mindre

Data Quality Manager till AstraZeneca

Ansök    Apr 30    Modis Sweden AB    Läkemedelsinspektör
Modis Life Science is now looking for a Data Quality Manager to AstraZeneca in Gothenburg. This is a consultancy assignment that will last until 2020-09-19. Start date as soon as possible. Deadline for application is May 13.   AstraZeneca is a major international healthcarebusiness engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique w... Visa mer
Modis Life Science is now looking for a Data Quality Manager to AstraZeneca in Gothenburg. This is a consultancy assignment that will last until 2020-09-19. Start date as soon as possible. Deadline for application is May 13.

 

AstraZeneca is a major international healthcarebusiness engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The role:

The role of Data Quality Manager (DQM) is to be a member of the AZ study team accountable for the data quality of the studies assigned in Early Clinical Development. The DQM will give guidance in data management processes and related activities to the ECD study teams; provide expertise in data management as well as information on AZ standards, processes, systems and expectations to the vendor. The role is key to enabling efficient, timely and high-quality data delivery, in close cooperation with the vendor. The DQM will also be involved in process development and improvement initiatives. The DQM is responsible for the quality of their own work and will be expected to manage their own daily planning. High attention to detail and a strong analytical mind-set is essential.

 

Typical Accountabilities:

• Provide clinical data management support to internal study teams in early clinical development, and project support to the Data Management Expert (DME).
• Communicate frequently and provide the right level of support to the lead data manager and other relevant functions at the vendor 
• Work within established frameworks to deliver a variety of tasks that support projects in meeting their objectives
• Actively participate in study team meetings and maintain awareness of the current status of the study
• Responsible for providing guidance on existing/new data standards
• Responsible for submitting any new/amended standards and request for LAB codes in line with ECD processes
• Review of key clinical research documents (e.g. Study synopsis, Protocols, Case Report Forms, DMP, SAP etc)
• Provide support, guidance and expertise to Data management activities (. e.g. electronic data capture, data transfer agreements, SDTM mapping, AZ specific coding, data transfer agreements, reconciliation issues.)
• Specialist in TA specific data capture and standards (Oncology, respiratory and cardiovascular) and CDISC standards
• Responsible for the data quality, risk mitigation and assessing solutions within studies
• Contribute to process development and improvement reviews, help define working practices and ensure noncompliant processes are escalated

Minimum requirements:

• BSc or post graduate qualification (or local equivalent) in computing, Life Sciences or equivalent experience
• At least 5 years data management and/or related work in pharmaceutical company or CRO
• Experience as a lead data manager
• Good knowledge of Clinical database applications such as EDC
• Excellent communication skills
• Working knowledge of good clinical practice, Clinical research, Clinical trial processes and the related regulatory requirements and terminology
• Ability to demonstrate strong time management and team working skills
• Truth seeking rather than success seeking
• Open to constructive feedback
• Excellent customer focus and good client relationship skills
• Demonstrate high attention to detail and flexibility in way of working.
• Excellent analytical and problem-solving skills

Preferred experience and key factors:

• TA Experience from Oncology, respiratory and cardiovascular
• Experience as a lead of a large phase III trial or multiple smaller trials
• Experience of vendor management
• Experience on Early Clinical Development trials
• SAS programing/mapping of data to SDTM
• CDISC education
• Technical knowledge of EDC systems

 

Send your application as soon as possible. For questions, please contact: Cecilia Larzon ([email protected]) Visa mindre