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Senior Quality Officer/Specialist

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Sophie Steels
Senior Recruiter



Sophie Steels
Senior Recruiter
+32 496 49 18 21


Jobomschrijving


  • Release product in accordance with approved specifications and procedures.
  • Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and
  • accuracy of products and production equipment.
  • Compile data and write summaries for periodic product reviews, investigations, complaints, and
  • deviations.
  • Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
  • Expert review.
  • Interact with multi-functional internal and external project teams to ensure compliance.
  • Respond to technical and quality issues and handle schedule and/or process-related conflicts.
  • Demonstrate understanding of applicable US and global regulations related to manufacture of
  • medicinal products (small molecules and biologics).
  • Monitor contractor performance to established Key Performance Indicators (KPI) and report
  • adverse trends.
  • Provide guidance to less experienced staff, as applicable.


Profiel

  • Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include +3 years in a Quality role
  • Excellent communication and organizational skills


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Gerelateerde vacatures

QC Medewerker


QA Compliance Officer


+32 496 49 18 21