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