Senior Specialist QC Electronical Laboratory Systems
(m/f/d)
Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: 879820/1
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Responsibilities
1. Lifecycle of QC systems (applications like LIMS, Tiamo, LabX, Empower, etc.) incl. administration, first & second level
2. Validation (CSV) of electronic laboratory systems
3. Support to meet customer and health authorities requirements/expectations
4. Provide timely support to the QC lab units for the investigations, change controls and deviations
5. Involved in gap assessment and actions related to the inspection/audit readiness for health authorities inspection and customer audits incl. participation in such
Profile
6. Strong knowledge of GxP (GMP, GLP, GAMP5) and Data Integrity (ALCOA+)
7. Experience in CSV (URS, IQ/OQ/PQ, Risk Assessments) and Annex 11 / 21 CFR Part 11 compliance
8. Proficient in Deviation, Change Control, and CAPA management
9. Solid experience with laboratory IT systems (LIMS, Empower, LabX, Tiamo, etc.)
10. Experience in audit and inspection preparation and support (FDA, EMA, Swissmedic)
11. Strong skills in Root Cause Analysis, gap assessments, and risk-based approaches
Benefits
12. Attractive salary package
13. HAYS Benefits
14. Renowned pharmaceutical company