Stability Programme Manager to AstraZeneca
Dfind Science & Engineering AB / Kemistjobb / Stockholm
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On behalf of AstraZeneca we are now looking for candidates for a consultant assignment within Stability Programme Management planned to last until december 2017.
An exciting opportunity has arisen to join the Global Stability group within Operations Quality, based in Södertalje, Sweden. Stability is looking for a Stability Programme Manager (SPM), Temporary role 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 role:
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.
Responisbilities:
The Stability Programme Manager is responsible for ensuring compliance with AstraZeneca 's commercial stabilityobligations 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
Business: Dfind Science & Engineering
City: Södertälje
Job type: Full time
Deadline for applications: 2017-07-13
More information: Julia Gonzales,
julia.gonzales@dfind.se, 0733434654 or Sofie Önnestam,
sofie.onnestam@dfind.se, 073 343 99 61
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-06-29ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-07-13
Ange följande referens när du ansöker: 201065336
Klicka på denna länk för att göra din ansökanKontaktSofie Önnestam
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3581304
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