QA Qualification Engineer — Cell Therapy GMP Impact

MindCapture BV; Beerse; Sur place; EUR 60 000 - 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 BV is seeking a QA Qualification Engineer to drive qualification activities for critical facilities, utilities and process equipment in a GMP environment. This consultancy role involves supporting health authority inspections, maintaining data integrity, and collaborating with cross-functional teams to ensure quality standards.

You will oversee qualification strategies, approve protocols and reports, and contribute to process improvements on an international pharma scale.

Qualifications

• Master’s degree in engineering with chemistry/analytical or pharmaceutical sciences background.
• Knowledge of current GMP regulations and EU/US guidance for cell therapy manufacturing.
• Ability to defend qualification strategies during health authority inspections.

Responsabilités

• Review and approve qualification and requalification activities for facilities, utilities and process equipment.
• Safeguard qualification status of critical production assets by identifying, qualifying and controlling requirements.
• Evaluate deviations with quality impact and ensure thorough investigations with CAPA.
• Review change controls and quality-related deviations with manufacturing stakeholders.
• Collaborate with quality functions to maintain qualification and compliance standards.
• Manage compliance status through calibration docs, master data, maintenance plans and records.
• Review and approve data integrity deliverables including audit trails and user access reviews.
• Support regulatory and customer inspections and act as QA qualification representative.
• Review qualification documents including protocols, reports, procedures, requirements, and corrective actions.
• Participate in system and process improvement initiatives while maintaining quality and compliance.

Connaissances

Quality assurance

GMP compliance

Data integrity

Change controls

CAPA investigations

Cross-functional collaboration

Documentation

Formation

Master’s degree in engineering

Pharmaceutical sciences

Outils

Computerised systems

Description du poste

MindCapture BV is seeking a QA Qualification Engineer to drive qualification activities for critical facilities, utilities and process equipment in a GMP environment. This consultancy role involves supporting health authority inspections, maintaining data integrity, and collaborating with cross-functional teams to ensure quality standards.

You will oversee qualification strategies, approve protocols and reports, and contribute to process improvements on an international pharma scale.