QA Qualification et Validation Expert (m/f/d).

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Job Details

zusammenfassung.

  • Branche
    Industrie
  • Kontakt
    Andreia Lourenço
  • Referenznummer
    129085-40159

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Job Details

An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-sur-Vevey.
As an integral member of the Quality Unit, you provide QA expertise for Process Validation and Analytical Validation:

  • You elaborate the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan
  • You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics
  • You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material.10. You ensure GMP compliance during all phases of qualification/validation.

An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-sur-Vevey.
As an integral member of the Quality Unit, you provide QA expertise for Process Validation and Analytical Validation:

  • You elaborate the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan
  • You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics
  • You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material.10. You ensure GMP compliance during all phases of qualification/validation.

  • Qualifikationen

    • You have a university degree with at least 5 years of experience in pharmaceutical quality environment
    • Proven experience in analytical methods validation and manufacturing process validation
    • Strong communication and strong team spirit
    • Good stress resistance
    • Fluent in French and English (oral & written)

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AL

Andreia Lourenço

  • Randstad Merck Aubonne

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