Stability Programme Manager, Läkemedelsbolag i Södertälje
Experis AB / Kemistjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla kemistjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos Experis AB i Södertälje,
Ekerö,
Nykvarn,
Botkyrka,
Huddinge eller i
hela Sverige Experis Engineering is now looking for a Stability Programme Manager (SPM) to join the Global Stability group within Operations Quality, at a big international pharmaceutical company in 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 a big international pharmaceutical company in Södertälje! This is a consultant assignment that will start as soon as possible and proceed until end of December 2017.
The Global Stability group, within Operations Quality at the company, is responsible for the overall coordination and quality assurance of the Global Commercial Stability Programme, providing continuous assurance that the 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 the pharmaceutical company '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 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.
Vi tar inte emot ansökningar via email
Skriv gärna in när du kan vara tillgänglig för start av uppdrag. Samt hur du löser boende om du inte bor på orten vi söker kandidater till. Urvalsprocessen sker löpande, det är därför viktigt att du skickar in din ansökan så snart som möjligt.
Ansökan till uppdrag som Stability Programme Manager
Har du frågor angående tjänsten eller konsultrollen är du välkommen att maila till kandidatspecialist Linnea Persson-eriksson
Välkommen med dig ansökan!
Varaktighet, arbetstid
Heltid Contract
Publiceringsdatum2017-07-06ErsättningEj angivet
Så ansöker duSista dag att ansöka är 2017-08-17
Ange följande referens när du ansöker: 26497
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 0181
KontorsadressKlarabergsgatan29
Jobbnummer 3593736
Observera att sista ansökningsdag har passerat.