Description du poste

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

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