QA Technician
On-siteVillers-le-Bouillet, Wallonia, Belgium
Job Summary
Implement and maintain the local Quality Management System to ensure compliance with global, European, and local regulations. Provide QA oversight for the product and process lifecycle by monitoring performance, identifying trends, and managing deviations, CAPAs, and change controls. Review operational documentation including forms, batch records, and labels, then release batches by approving incoming materials and final products. Ensure personnel receive appropriate training and maintain training matrices. This role supports operational activities within Cryoport Systems' supply chain partner for the life sciences industry, focusing on quality assurance in the biotech sector. Fluency in French and English is required, with a Bachelor's degree and two years of QA or RA experience in a pharmaceutical or biotech environment preferred.
Required Qualifications
- Bachelor's degree in a life science-related field
- At least 2 years of experience in a pharmaceutical, biotech, or CDMO environment, in a QA or RA role
- Knowledge of GMP, GTP, GDP, HBM regulations and standards (ISO, ICH, EDQM)
- Strong analytical skills
- Attention to detail
- Ability to anticipate impacts and set priorities
- Proactive attitude
- Ability to work autonomously
- Ability to adapt to a fast-changing environment
- Fluency in French & English
Desired Qualifications
- B2 level preferred
- Knowledge of Human Body Material Belgian legislation
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