PpbSenior Specialist QC Electronical Laboratory Systems /b /p /p p(m/f/d) /p Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: /1 ppb Diesen Job teilen oder drucken /b /p /p ppb Responsibilities /b /p /p liLifecycle of QC systems (applications like LIMS, Tiamo, LabX, Empower, etc.) incl. administration, first second level /liliValidation (CSV) of electronic laboratory systems /liliSupport to meet customer and health authorities requirements/expectations /liliProvide timely support to the QC lab units for the investigations, change controls and deviations /liliInvolved in gap assessment and actions related to the inspection/audit readiness for health authorities inspection and customer audits incl. participation in such /li ppb Profile /b /p /p liStrong knowledge of GxP (GMP, GLP, GAMP5) and Data Integrity (ALCOA+) /liliExperience in CSV (URS, IQ/OQ/PQ, Risk Assessments) and Annex 11 / 21 CFR Part 11 compliance /liliProficient in Deviation, Change Control, and CAPA management /liliSolid experience with laboratory IT systems (LIMS, Empower, LabX, Tiamo, etc.) /liliExperience in audit and inspection preparation and support (FDA, EMA, Swissmedic) /liliStrong skills in Root Cause Analysis, gap assessments, and risk-based approaches /li ppb Benefits /b /p /p liAttractive salary package /liliHAYS Benefits /liliRenowned pharmaceutical company /li