Quality Assurance Engineer - CAR-T

📋 Description

• Guard qualification status of critical assets; mitigate deviations affecting quality.
• Collaborate with Manufacturing to approve change controls and investigate deviations.
• Build strong connections with different quality organizations.
• Manage asset compliance via procedures, calibration records, and data.
• Support regulatory and customer inspections and act as QA spokesperson.
• Approve qualification docs including changes, protocols, reports and SOPs.

🎯 Requirements

• Master’s degree in engineering with chemistry or analytical background or pharmaceutical sciences.
• Knowledge of cGMP and FDA/EU guidance for cell therapy manufacturing.
• Affinity with computerized systems and data management in critical production assets.
• Strong communication; able to work cross-department in a changing environment.
• Fluent in Dutch and English, both oral and written.
• Strong analytical thinking, risk assessment, and collaboration skills.