The Company
Our client is a professional Pharmaceutical organisation, based in Netherlands. They focus on the discovery, development, manufacturing and marketing of biologic products to protect people worldwide from a range of diseases. Together with another 150 locations world wide they are trying to achieve the best possible results for their health.
Role Description
As a QA Officer you will be responsible for the batch documentation review of incoming raw materials and subsequent release.
Responsibilities
- - Review of paper and electronic Batch Records on completeness, clarity, and GMP compliance;
- - Review of raw material related documentation and release of raw materials
- - Provide advice to requesting departments regarding GMP aspects;
- - Review and approve QA controlled documentation (SOP’s, Batch Records, work instructions)
- - Assessing change requests on consistency, relevance, GMP compliance, and clarity
- - Review and Preparation of batch release documentation;
- - Support the department in continuous improvement activities
Requirements
- - BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
- - Up to date knowledge of current GMP regulations;
- - Experience in pharmaceutical or related industry (QA, QC, Production Operations or supporting functions).
Other Information
For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.