Stability Programme Manager, AstraZeneca Södertälje

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.

Placering: 
Stockholms län, Stockholm
Bransch: 
Teknik, Naturvetenskap, Hälso-,Sjukvård, Omsorg
Antal tjänster: 
1

 

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

Vad erbjuds du som konsult på Experis?


Låt Experis öppna dörrarna till ditt drömföretag. Vi samarbetar med många av Sveriges populäraste företag och kan dessutom erbjuda dig: 

• Möjlighet att arbeta i svensk och internationell miljö.
• Spännande tjänster på marknadens intressantaste företag.
• Utvecklingsmöjligheter på både lång och kort sikt.
• Nätverkande med personer inom din yrkeskategori genom såväl nätverksträffar som sociala aktiviteter.

Vår verksamhet bygger på att våra anställda trivs och vill stanna hos oss. Våra konsulter får en trygg anställning med allt vad det innebär i form av övertidsersättning, semester, tjänstepension och försäkringar enligt kollektivavtal. Friskvårdsbidrag och företagshälsovård är exempel på annat som vi erbjuder alla våra anställda.

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Ansökan till uppdrag som Stability Programme Manager


Har du frågor angående konsultrollen är du välkommen att maila Kandidatspecialist
zara.karlsson@se.experis.com

Välkommen med dig ansökan!