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QA Sterile process/Packaging

  • Location:

    Barcelona, Spain

  • Contact:

    Fernando Martin

  • Job type:

    Contract

  • Industry:

    Life Sciences

  • Contact email:

    fernando_martin@oxfordcorp.com

We need QA TECHNICIAN for an international pharmaceutical company based in Barcelona:

MAIN RESPONSABILITIES:

  • Ellaboration of dossier corresponding parts which support Sterility Assurance Package for products with scope FDA.
  • Evaluation of compliance and assurance of current requirements in terms of Regulatory Guidelines and GMP, of manufacturing processes and validation for sterile products, mainly by terminal sterilization processes.
  • GMP activities of review of documentation for release.
  • Support in audits & evaluation of GMP compliance requirements by suppliers.

PROJECT SCOPE:

  • Main focus is on sterile generic products for FDA market.

EDUCATIONAL REQUIREMENTS:

  • University Degree in Life Science.
  • Minimum 3 years of experience in production/QA with sterile production products.
  • Excellent level of english and editorial skills