Main Responsibilities:
1. Owning, shaping and managing quality tasks: CAPA and NC ownership and investigation documentationAudit front room supportQuality database support (COMET)
2. Keeps track on due dates and writes investigation reports with a best-in-class quality.
3. Work in close collaboration with department manager on timeline & deliverables. Managing and shaping internalprocesses.
4. Close cooperation with internal departments.
5. Create impact assessments, investigation reports and riskfiles.
6. Create storylines for audit front rooms.
7. Can defend his work in front of an auditor.
8. Manage individuals on their deliverables.
9. Keep track on ongoing changes within the department
10. Support the department leader on quality actions
11. Working with engineers and equipment owners as well as external providers to be compliant within our processes
12. Support manufacturing plant excellence at the site by providing guidance
13. Technical optimization of processes and systems / improvement measures
Qualifications and Experience:
14. Relevant working/residency permit or Swiss/EU-Citizenship required
15. Preferably master diploma (preferably mechanical, electrical, industrial, chemical) or equivalent
16. Experience in GMP quality systems preferably in pharma.
17. Audit front room experience
18. Aware of maintenance management, GMP practices
19. Excellent oral and written communication skills at different hierarchical levels in English
20. Fluent German speaking is a must
21. Ability to work in a matrix organization
22. Ability to lead without direct management responsibility
23. Excellent analytical skills