ZUID HOLLAND, Netherlands
Technical Specialist (QC)
This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines. For this specific role, you will join the Covid-19 project.
As a Technical Specialist you will support the required analytical activity and handle quality and compliance related topics, including deviations. CAPA, NPI Gap Assessments and Change Controls.
- Ensure that assays are executed in a timely manner, cGMP compliant and safe.
- Perform GAP analysis, protocols and reports during new product implementation.
- Act as a SME for a set of techniques during internal/external meetings.
- Create URS's in collaboration with automation specialist and provide input for the new equipment or technologies to NPI Lead.
- Acting as lead investigator for Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining CAPAs.
- Monitor timely closure of medium/high-level investigations and associated CRA’s.
- Bachelor's Degree in Biology, Biotechnology or similar.
- 2-4 years of experience in a GMP environment.
- Knowledge of testing techniques (chemical separations, sample management, bioassays, AVA/Mycoplasma or biophysical techniques).
- Knowledge of CAPAs, non-conformances, change controls.
- Excellent communications skills in English.
For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or email@example.com