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).
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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