QA/QC Officer (Potential QP Internship)
airliquidehr · Schelle
Job description
About the role
Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands are hiring a QA/QC Officer in Schelle, Belgium, within the Benelux Pharmaceutical / Quality Department. You report directly to the Quality Control Manager (Qualified Person) and support daily operational quality tasks for medicinal and non-medicinal products at the European GMP site. You monitor quality along the whole chain, from starting materials to finished products, and are directly responsible for the final batch release of non-medicinal products and raw materials.
Key responsibilities
- Review production and laboratory batch documentation according to SOPs, regulatory requirements and customer quality agreements, and perform the final batch release of non-medicinal products and raw materials, approving certificates of analysis.
- Conduct quality tours and monitor GMP and flow/zoning compliance in production and lab areas.
- Lead investigations into deviations, OOS results, customer complaints and non-conformities, and handle change controls and CAPAs.
- Prepare, execute and follow up validation and qualification activities for equipment, instruments and processes, and authorise and update SOPs and quality documents.
- Write the annual Product Quality Review (PQR) for medicinal products and support site health authority, customer, supplier and internal audits.
- Deliver GMP, GDP and pharmacovigilance training to QC operators, production, warehouse and driver staff.
Required profile
- Bachelor's or Master's degree in Life Sciences, Bio-engineering, Industrial Pharmacy, Chemistry or a related field.
- 0 to 3 years of experience in a QA/QC environment (pharmaceutical, biotech or medical devices); first hands-on experience in a GMP/GLP setting is highly valued.
- Fluent Dutch and English; knowledge of French is a strong asset.
Required skills
- Knowledge of GMP, GDP, GLP, Ph. Eur. and ISO 13485 / MDR.
- Interest in quality investigations, root-cause analysis and batch record review.
- Basic understanding of validation and qualification activities.
- Proficiency with MS Office and Google Workspace.
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Published 21 uur geleden
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airliquidehr
Schelle