For this renowned Biotech in Leiden I am looking for a Quality Assurance Specialist for an assignment of 3 to 6 months.
- Batch record review of manufacturing documentation. Ensure that all operations meet cGMP requirements
- Batch dossier compilation & certificate preparation in collaboration with the QP
- Reliable review and release of raw materials that are needed for the manufacturing process
- Issue management in collaboration with production and support departments. On the shop floor support where necessary.
- Represents the Quality department in operational meetings when needed
- MSc in a scientific discipline e.g. Pharmacy or Bio-Pharmaceutical Sciences
- 5+ years of quality assurance/quality control experience in a pharmaceutical GMP setting, by preference vaccines.
- Solid experience with GMP-standards
- Has experience with review activities of manufacturing documentation (batch records) in a regulated environment.
- Preferably has knowledge and experience with cell culture, purification processes, operations and business processes within a GMP environment.
- 1st of April 2021 (ASAP)
- 3-6 months with high change of extension
If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at email@example.com