CQV Engineer


Lausanne
Negotiable
CR/571309_1765196895
CQV Engineer

We are looking for an experienced CQV consultant to support qualification and validation activities in a pharmaceutical environment. This is a temporary position for a duration of 6 months. The role involves managing equipment qualification projects and, ideally, computerized system validation (CSV). Experience in chemical production is highly desirable.

Main Responsibilities

  • Commissioning & Qualification:
    • Drafting and reviewing IQ/OQ/PQ protocols.
    • Performing qualification tests on production equipment.
    • Managing deviations and implementing CAPAs.
    • Preparing and following up on qualification reports.
  • Validation:
    • Computerized System Validation (CSV) according to GAMP 5.
    • Drafting URS, FS, DS, and test protocols.
    • Ensuring compliance with regulatory requirements (FDA, EMA).
  • Documentation & Compliance:
    • Guaranteeing traceability and document compliance.
    • Adhering to GMP standards and internal guidelines.
  • Coordination:
    • Collaborating with production, quality, and engineering teams.
    • Participating in project meetings and providing regular reporting.

Profile

  • Experience: Minimum 5 years in CQV roles with full mastery of associated activities (IQ/OQ/PQ qualification, protocol drafting, deviation management, CSV validation).
  • Technical Skills:
    • Qualification of pharmaceutical production equipment.
    • Knowledge of computerized systems and CSV validation (a plus).
    • Ideally, experience in chemical production.
  • Languages: Fluent in French and English (spoken and written).

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