Senior Scientist Raw Material
(m/f/d)
Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: 836328/1
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Responsibilities
1. Ensure GMP-compliant introduction and release of manufacturing materials, including specifications, sampling plans, and documentation
2. Review analytical data in LIMS, including job authorization, result certification, and ensuring data integrity
3. Independently review and certify raw data, including internal and external Certificates of Analysis (CoA)
4. Manage deviations, Out of Specification (OOS) results, and change controls within the area of responsibility
5. Maintain audit and inspection readiness, including participation in customer and authority audits
6. Collaborate with QA and Supply Chain to resolve quality issues related to material batch release
7. Support creation of Material Qualification Forms and technical specifications in collaboration with process owners
8. Participate in Gemba Walks and mock audits to drive continuous improvement
9. Contribute to PPI projects and other QC processes as needed
10. Act as a subject matter expert, leading or supporting resolution of technical issues
Profile
11. Bachelor’s or Master’s degree in Life Sciences (, chemistry, biochemistry, biology); alternatively, a laboratory apprenticeship with relevant industry experience may be accepted
12. Solid experience in GMP-regulated industries, ideally within global corporate environments
13. Hands-on experience in pharmaceutical Quality Control and/or Quality Assurance
14. Proven experience managing deviations, change controls, and CAPA processes
15. Strong collaboration skills with cross-functional teams to drive project success
16. Fluency in English is required; German proficiency is a strong asset
17. Experience with ERP systems, especially SAP, is advantageous
18. In-depth understanding of GMP regulations and standards to ensure compliance
19. Excellent technical writing skills for accurate documentation and reporting
20. Ability to work independently and act as a subject matter expert in assigned areas
Benefits
21. Renowned pharmaceutical company
22. Furhter paid training oppurtunities
23. Attractive salary package