Senior Specialist QC Electronical Laboratory Systems (m/f/d)

Über uns

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

Aufgaben

• 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

Profil

• 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

Wir bieten

• Attractive salary package
• HAYS Benefits
• Renowned pharmaceutical company

Ihr Kontakt

Referenznummer
879820/1

Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

Anstellungsart
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