QA Qualification Engineer

• Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
• Safeguard the qualification status of critical production assets by ensuring critical system, product, and process requirements are identified, qualified, and controlled.
• Evaluate equipment-related deviations with potential quality or compliance impact and ensure thorough investigation with appropriate corrective or preventive actions.
• Work closely with manufacturing stakeholders to review and approve new change controls and quality-related deviations.
• Collaborate with different quality functions to maintain consistent qualification and compliance standards.
• Manage the compliance status of critical production assets through review and approval of calibration documentation, master data, maintenance plans, and operational records.
• Review and approve data integrity deliverables including system audit trails and user access reviews.
• Support preparation for regulatory and customer inspections and act as a QA qualification representative.
• Review and approve qualification documents including protocols, reports, procedures, requirements, rationales, discrepancies, and related corrective actions.
• Participate in system and process improvement initiatives while ensuring quality and compliance requirements are maintained.

What they ask

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences.
• Strong quality awareness with knowledge of current GMP regulations and relevant European and US regulatory guidance for cell therapy manufacturing.
• Ability to support and defend qualification strategies and documentation during health authority inspections.
• Affinity with computerised systems, system parameter configurations, and data management for critical production assets.
• Strong communication skills with the ability to collaborate effectively across departments in a continuously changing environment.
• Thorough knowledge of Dutch and English, both spoken and written.
• Strong analytical thinking, risk assessment, and communication capabilities.
• Strong collaboration and teamwork skills.