GMP QA Qualification Engineer — Cell Therapy

MindCapture; Beerse; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Résumé du poste

MindCapture is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. You will ensure compliance and support regulatory inspections as a QA qualification representative.

In this consultancy role, you review qualification documents, manage calibration reviews and collaborate with manufacturing to maintain data integrity and change controls.

Qualifications

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences
• Strong GMP knowledge and awareness of European/US guidelines 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 and cross‑functional collaboration in a 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

Responsabilités

• Review and approve qualification and requalification activities for facilities, utilities and process equipment
• Safeguard the qualification status of critical production assets by ensuring requirements are identified, qualified and controlled
• Evaluate equipment related deviations with potential quality or compliance impact and ensure thorough investigations and CAPAs
• Work closely with manufacturing to review and approve change controls and quality deviations
• Collaborate with different quality functions to maintain qualification and compliance standards
• Manage the compliance status of critical assets through review of calibration docs, master data, maintenance plans and records
• Review and approve data integrity deliverables including system audit trails and user access reviews
• Support preparation for regulatory and customer inspections as QA qualification representative
• Review and approve qualification documents including protocols, reports, procedures and discrepancies
• Participate in system and process improvement initiatives while upholding quality and compliance

Connaissances

Quality awareness

GMP knowledge

Data management

Communication across departments

Risk assessment

Analytical thinking

Dutch and English proficiency

Teamwork

Formation

Master’s degree in engineering with chemistry/analytical background or pharmaceutical sciences

Outils

Computerised systems

System parameter configurations

Description du poste

MindCapture is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. You will ensure compliance and support regulatory inspections as a QA qualification representative.

In this consultancy role, you review qualification documents, manage calibration reviews and collaborate with manufacturing to maintain data integrity and change controls.