CAR-T QA C&Q Engineer
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Our client, a prominent pharmaceutical organization, is seeking a CAR-T QA C&Q Engineer to support their innovative manufacturing operations. This role is responsible for the oversight and approval of qualification activities for facilities, utilities, and process equipment within a specialized therapeutic environment.
- Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
- Maintain the qualification status of critical production assets by ensuring all system-critical aspects are identified and controlled.
- Evaluate and investigate deviations related to equipment issues, defining and implementing appropriate corrective and preventive actions.
- Manage the compliance status of production assets through the review of calibration records, maintenance plans, and master data.
- Oversee data integrity deliverables, including system audit trails and user access reviews.
- Approve essential documentation such as change controls, protocols, URS, and SOPs.
- Participate in regulatory inspections as a subject matter expert for quality assurance and qualification.
- You have a Master's degree in Engineering, Pharmaceutical Sciences, or a related field with a chemistry or analytical background.
- You possess knowledge of cGMP regulations and FDA/EU guidance related to the manufacturing of medicinal products.
- You bring an affinity for computerized systems, including system parameter configurations and data management.
- You have strong analytical thinking, risk assessment capabilities, and the ability to work effectively in a team.
- You are fluent in Dutch and English, both orally and in writing.
Nice to Haves
- Experience defending strategies and documentation during health authority inspections.
- Proven ability to work cross-departmentally in a continuously changing environment.
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