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QA Release - QC Specialist

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28/03/2024 100% Temporary (short-term)
AXEPTA SA

Our client, a global and growing international biotechnology company with a strong reputation, is looking for a QA Release - QC Specialist for the quality oversight of Drug Substance batches testing and release.

This person will be responsible for QA oversight of QC activities (incl. routine testing and methods transfer/validation), ensuring QC activities are performed according to Incyte Quality policies, cGMP and applicable regulations (approx.. 80% of activity) and for batch disposition preparation and related activities, confirming compliance with GMP, internal procedures, specifications and registration files. (approx.. 20% of activity).

QA Release - QC Specialist

Your responsibilities :

  • Collect and review all records required for Drug Substance batch disposition and shipping.
  • Chair the weekly Drug Substance disposition meetings and maintain related KPIs.
  • Act as QA representative for QC topics, including (but not limited to):
    • review and approval of methods transfers and validation protocols and reports
    • commissioning and qualification of laboratory equipment
    • deviations, OOS and OOT
    • changes related to QC testing
    • SOPs development, updates and periodic review.
    • specifications and methods updates
    • risk assessments
  • Ensure QA oversight for all quality events related to the area of responsibility
  • Support Health Authorities’ Inspection Readiness Programs
  • Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements
  • Contribute positively to a strong culture of Quality, business integrity and ethics

Your profile :

  • Scientific background in pharmacy, biotechnology, chemistry…
  • Significant experience from pharmaceutical industry.
  • Minimum of 3 years related experience in QA for QC topics.
  • Experience in batch release is preferred.
  • Must speak English and French

Contact

Morgane Cayuela

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About the company

5,0 (2 reviews)

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