(Senior) QA Specialist
(Senior) QA Specialist biologics
For a CDMO, specialised in brain blood-barrier pharmaceutical solutions, we are currently looking for a (Senior) QA Specialist. The company is based in Leiden with a brand new production location.
Reporting to the Production Manager, you will be responsible for the daily QA responsibilities like handling off deviations, CAPA's, change controls, batch release and complaints handling. Additionally you are focused on site improvement projects, supporting internal and external audits and training of operators regarding quality.
- Maintenance of the QMS (GMP)
- Handling of deviations, CAPA's and change controls
- Training of operators and other personnel
- Prepare and review of documents regarding batch release
- Writing of SOP's and quality documentation
- Participate in improvement projects regarding quality
- BSc in Life Sciences
- Minimum 3 years of experience within a QA environment
- Excellent working knowledge of GMP, ISO 9001
- First work experience with Biologics is an asset
- You speak / write fluent English (Dutch preferred)
- Team player and self-starter
Are you interested? Respond via the button below! For questions please feel free to call.