Stability Programme Manager, AstraZeneca Södertälje
Experis AB / Kemistjobb / Stockholm
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hela Sverige Experis Engineering is now looking for a Stability Programme Manager (SPM) 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.
Experis Engineering is now looking for a Stability Programme Manager (SPM) 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 we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're 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 as a Stability Programme Manager
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 both 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
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Låt Experis öppna dörrarna till ditt drömföretag. Vi samarbetar med många av Sveriges populäraste företag och kan dessutom erbjuda dig:
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* Nätverkande med personer inom din yrkeskategori genom såväl nätverksträffar som sociala aktiviteter.
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Ansökan till uppdrag som Stability Programme Manager
Har du frågor angående konsultrollen är du välkommen att maila till anna.aurell-
Välkommen med dig ansökan!
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2017-05-09ErsättningEj angivet
Så ansöker duSista dag att ansöka är 2017-05-30
Ange följande referens när du ansöker: 22758
Klicka på denna länk för att göra din ansökanKontaktAnna Aurell-Sundvall
aau@se.experis.com 08 - 736 29 66
FöretagExperis AB
AdressExperis AB
11181
11181 0180
KontorsadressKlarabergsgatan 29
Jobbnummer 3486499
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