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 for the Benelux Pharmaceutical / Quality Department, reporting directly to the Quality Control Manager (Qualified Person). The role provides daily operational support for pharmaceutical and quality tasks at the European GMP site in Schelle, monitoring quality from starting materials to finished products and ensuring compliance with GMP, GDP, MDR and ISO 13485. It is described as a potential QP internship.
Key responsibilities
- Review production and laboratory batch documentation against SOPs, regulatory requirements and customer quality agreements, and perform the final batch release of non-medicinal products and raw materials, approving certificates of analysis.
- Manage the release of raw materials, packaging materials and intermediate products.
- 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, authorise and update SOPs and quality documents, and write the annual Product Quality Review.
- Support site health authority inspections, customer and supplier audits and internal self-inspections.
- 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.
- Proficiency with MS Office and Google Workspace.
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Published 21 hours ago
Expires 1 month from now
3 views · 0 interested
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airliquidehr
Schelle