Job Description

Senior Specialist QC Electronical Laboratory Systems

(m/f/d)

Freelance/Contracting project Lengnau, Berne Start date: asap Reference number: /1

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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) an...

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