Quality Compliance Specialist
(m/f/d)
Freelance/temporary employment for a project Neuchatel Start date: asap Reference number: 864224/1
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Responsibilities
1. Lead and continuously improve the GMP self-inspection program, including annual planning and execution
2. Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness
3. Perform gap assessments on global procedures and drive alignment across site functions
4. Coordinate cross-functional activities and ensure effective communication with all departments
5. Support internal, external, and mock audit preparation, including document review and QA input
6. Act as backroom/ACC or scribe team member during audits and inspections
7. Serve as Data Integrity Champion and ensure consistent DI implementation across the site
8. Prepare and present compliance topics to the Quality Council and site leadership
9. Support continuous improvement initiatives and coordinate operational activities within the compliance team
10. Act as back-up for the Quality Compliance & Systems Expert when required
Profile
11. University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline
12. Solid experience in biotechnology and/or pharmaceutical industry
13. Strong knowledge of GMP requirements and Quality Systems
14. Understanding of manufacturing, QC laboratory, and warehouse processes for biological products
15. Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles
16. Experience supporting audits and regulatory inspections
17. Skilled in writing, reviewing, and updating SOPs and technical documentation
18. Familiarity with risk management tools (FMEA, RCA, etc.)
19. Proficiency in French and English (minimum B2)
20. Experience with eQMS tools (, Veeva Vault, TrackWise), Microsoft Office, SharePoint, and Power BI
Benefits
21. A very renowned company
22. Continuous support during the assignment
23. Individual all-round care: Support throughout the entire application phase