Metrology Supervisor (m/f/d)
Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: 869907/1
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Responsibilities
1. Lead and oversee daily metrology and calibration activities across GMP areas (manufacturing, QC, labs, utilities)
2. Ensure all measuring and test equipment is calibrated and maintained in compliance with GMP, FDA, EMA, and ISO standards
3. Manage the full calibration lifecycle: planning, execution, review, approval, and documentation
4. Review and approve calibration certificates, OOT results, deviations, and technical assessments
5. Drive and manage deviation, CAPA, and change control processes related to metrology
6. Ensure data integrity according to ALCOA+ principles in all records and electronic systems
7. Support internal/external audits and regulatory inspections, ensuring inspection readiness
8. Collaborate with QA, Engineering, Validation, and Manufacturing on equipment qualification (IQ/OQ/PQ)
9. Monitor and report KPIs (compliance, turnaround time, right-first-time performance)
10. Train, mentor, and develop metrology technicians in GMP and technical competencies
Profile
11. Bachelor’s degree in Engineering, Life Sciences, or a related technical field
12. Experience in metrology/calibration within a GMP-regulated pharma/biotech environment
13. Proven leadership or supervisory experience
14. Strong knowledge of GMP regulations (21 CFR 210/211, Annex 11) and regulatory expectations
15. Solid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation
16. Experience with computerized system validation (CSV) and ALCOA+ data integrity requirements
17. Familiarity with QMS processes, including deviations, CAPA, and change control
18. Strong analytical and problem-solving skills with a structured, quality-driven mindset
19. Excellent communication and cross-functional collaboration skills
20. Continuous improvement mindset with experience in process optimization
Benefits
21. Renowned pharmaceutical company
22. Attractive salary package
23. HAYS Benefits