Stability Programme Manager to AstraZeneca, Södertälje
Adecco Sweden AB / Läkarjobb / Södertälje
2017-04-12
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hela Sverige Adecco Life Science is now looking for a Stability Programme Manager to join the Global Stability group within Operations Quality, at AstraZeneca, Södertälje!
This is a consultant assignment that will start as soon as possible and proceed until end of December 2017.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world 's most serious diseases. But AstraZeneca is more than one of the world 's leading pharmaceutical companies. At AstraZeneca, they are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The Global Stability group, within Operations Quality at AstraZeneca, is responsible for the overall coordination and quality assurance of the Global Commercial Stability Programme, providing continuous assurance that AstraZeneca products remain at the highest level of Quality throughout the shelf life. This involves developing Stability strategies that meet the product lifecycle requirements, dealing with related issues and providing quality oversight to the manufacturing units and Health Authorities.
The role
The Stability Programme Manager is responsible for ensuring compliance with AstraZeneca 's commercial stability obligations by generation, provision and maintenance of the Global Commercial Stability Programme.
* Generation and maintenance of the Stability Master Plans and the supporting stability test protocol information.
* Ensure the global Stability Programme fulfils all regulatory requirements, and is optimized and effective.
* Communication of the Stability Master Plans to the Stability QC Centres.
* Translation of stability sections in CMC documentation and Commitments into the Stability Master Plan.
* Assure the provision of accurate, submission ready stability data information that is in compliance with market specific Health Authority.
* Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.
* Maintenance and update of storage life records within S-Life.
The roles demand thorough understanding of pharmaceutical stability testing and a full overview of Operations activities and how this contributes to achieving the objectives of the business. The job holders have effective levels of interactive communication with stakeholders and project team members directly advising and influencing them.
Minimum Requirements - Education and Experience
* Educated to BSc level, fluent in Swedish and English
* Thorough knowledge of cGMP requirements and their applicability to Operations and Quality
* Strong communication skills and ability to build effective relationships with team and customers
* Excellent team working skills
* A solution based approach
* Desirable Requirements
* Experience in Operations and/or R&D
* Strong knowledge of and background in Quality systems eg stability management, QC or QA
* Able to demonstrate the drive and energy to establish the role and make a difference
What do we offer?
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Adecco Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
Unfortunately we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz,
nalin.yilmaz@adecco.se or Heidi Pettersson,
heidi.pettersson@adecco.seWe look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-04-12ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-05-11
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
nalin.yilmaz@adecco.seHeidi Pettersson
Heidi.Pettersson@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Jobbnummer 3436474
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