At our client company in Geleen, you will review batch records, samples and certificates of analysis, prepare QP release and support QA in production, QC and logistics. MBO+ level, quality-systems experience, and good Dutch and English are required.
The role
At our client company in Geleen, Limburg, you will work as a QA Release Officer. You will review batch documentation for registered products and the associated samples, and prepare registered finished products and IMPs for release by the QP. You will also provide QA support on the shop floor in production, QC and logistics.
Responsibilities
- Take responsibility for the direct, independent review of batch documentation, inspection reports, samples and certificates of analysis.
- Prepare registered finished products and IMPs for release by the QP, and handle the release of excipients, artwork and intermediates.
- Issue release labels and forward certificates of analysis for released products.
- Identify deviations and trends; independently initiate deviations and holds, and maintain and archive holds.
- Support the quality policy; archive and print batch documentation and process batch administration in the ERP system.
- Review and prepare procedures, work instructions and forms for the release process, and initiate document changes.
- Support production and/or QC on the shop floor, help improve quality in production, QC and logistics, and take part in improvement initiatives.
- Keep up with developments in the field and changes to regulations, especially GMP guidelines.
What you bring
- MBO+ level of professional knowledge and judgement.
- Experience with quality systems, preferably in the pharmaceutical industry.
- Good spoken and written Dutch and English.
- Knowledge of GMP/GxP guidelines and ISO 13485 is an advantage.
- Solid knowledge of Word and Excel.
What’s offered
- A challenging role with excellent employment conditions in a dynamic, inspiring environment.
- Flexible working hours; the organization is continuously developing.
- The opportunity to work with an enthusiastic team.