We are looking for an experienced QA officer! In this position as QA Specialist you will be responsible for wide range of QA activities to ensure high quality production of an innovative cancer treatment under cGMP and GLP regulations.
An international, high-tech biopharmaceutical company in Hoofddorp that produces an innovative cancer immunotherapy is looking for a QA Specialist. As QA specialist, you are a key link in the release of quality products. You review and approve documentation and data from manufacturing, environmental monitoring and QC for the in-process and finished products. You prepare the final documentation for QP release and make sure everything is under the correct regulatory requirements within the organization. Other QA-related tasks such as GEMBA walks, approval of deviations and CAPA, may also be part of your tasks.
- Safeguard compliance with company and cGMP requirements
- Review and approve documentation for in process and finished products from various departments.
- Compile binder documents in preparation for QP release
- Identifications and report of deviations to senior colleagues
- Additional QA activities may apply as well depending on experience
- Finished HBO or WO education in relevant field (e.g. (Bio)medical, Life Science or Analytical Chemistry)
- Experience in a QA position under GMP regulations is a must
- Able to communicate in a clear and concise way in English
- Being able to prioritize and plan and follow up with and for your team
- Start with an Oxford contract, long term position
- Salary range: €3863 - €4200, depending on experience
- Fulltime position, 32 hours is discussable
- Region: Amsterdam
Vacancy number: 21638
IMPORTANT NOTE: Please do not apply if you do not have a valid working permit in the Netherlands. Your application will not be processed.