QA Engineering Expert

vor 3 Wochen

Aubonne, Schweiz Randstad Vollzeit

For our client Merck based in Aubonne, we are looking for a QA Engineering Expert for a duration of 9 months (until 31.12.2024).

Your role:

  • Ensure that equipment & automated systems implemented are in accordance with internal procedures and current guidelines/regulations (including procedures related to change, risk and deviation management)
  • Support Equipment and Automated Systems deviation management.
  • Support, review and approve change control proposal (CCP) as QA engineering for projects
  • Participate to risk assessments
  • Review and approve quality documents (design documents, validation plans & summary reports, procedures, protocols, data reviews, reports and procedural documents)
  • Ensure that validation, calibration and preventive maintenance programs are in place and are respected

    Routine activities:

    • Review and approve quality documents (operational documents, procedures, forms, intervention report for automation activities) for equipment and automated systems activities
    • Ensure support for deviations related to equipment and automated systems including QA assessment, investigation and CAPA review / approval and closure
    • Ensure that periodical technical interventions programs are in place and respected.
    • Participate to annual reviews as required.
    • Ensure QA activities in SAP-PM system: equipment/system and maintenance plans creation /modification/removal
    • Support department to guarantee that equipment and automated systems procedures and forms are understandable and easy to complete and review.
    • Participate to seminars and training sessions on equipment and automated systems qualifications best practices to maintain "state-of-the-art" in-house expertise.
    • Ensure backup of the QA engineer for project and routine activities

      qualifications

      Your profile:

      • English B2 or above
      • Master / Bac +5 level
      • Knowledge of equipments and automated systems
      • Knowledge on Trackwise, CSV and SAP are mandatory
      • 3-5 years of experience in a similar position
      • Experience in Quality Assurance
      • Expertise in cGMP best practices

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