Review batch documentation and quality records, prepare registered products and investigational medicinal products for QP release, and support QA across production, QC and logistics. MBO+ level and experience with quality systems are required.
The role
As a QA Release Officer at our client company in the pharmaceutical sector in Geleen, Limburg, you review batch documentation and prepare registered finished products and investigational medicinal products (IMPs) for release by the Qualified Person (QP). You also provide QA support on the production, QC and logistics floors.
What you will do
- Independently review completed batch documentation, related samples, inspection reports and certificates of analysis.
- Prepare registered finished products and IMPs for QP release; release excipients, artwork and intermediates.
- Issue release labels and forward certificates of analysis for released products.
- Identify deviations and trends; independently initiate deviations and product holds, and track and archive hold records.
- Review and draft procedures, work instructions and forms for the release process, and initiate document changes.
- Print and archive batch documentation and complete batch-related administration in the ERP system.
- Support production and/or QC, contribute to the quality policy and improvement initiatives, and help strengthen quality across production, QC and logistics.
What you bring
- MBO+ level.
- Experience with quality systems, preferably in the pharmaceutical industry.
- Good spoken and written Dutch and English.
- Knowledge of GMP/GxP; knowledge of ISO 13485 is an advantage.
- Strong knowledge of Word and Excel.
What is offered
Our client company offers a challenging role with excellent employment conditions in a dynamic, inspiring work environment. The organization continues to develop. Working hours are flexible, and you will join an enthusiastic team.