QA Qualification Engineer – GMP Cell Therapy Compliance

MindCapture; Oost-Vlaanderen; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Group insurance

Net expense allowance

Company car

Training & development

Résumé du poste

MindCapture is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. This consultancy role supports data integrity and change control while ensuring compliance with European and US cell therapy guidance.

You will collaborate with manufacturing and quality teams, prepare for inspections, and review protocols and reports as part of ongoing system and process improvements.

Qualifications

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences.
• Strong GMP knowledge and familiarity with European and US guidance for cell therapy manufacturing.
• Ability to defend qualification strategies and documentation during health authority inspections.
• Affinity with computerised systems and data management for critical production assets.
• Strong communication and cross‑department collaboration skills.

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 potential quality or compliance impact and ensure investigations with corrective actions.
• Review and approve change controls and quality-related deviations with manufacturing stakeholders.
• Collaborate with quality functions to maintain qualification and compliance standards.
• Manage compliance status through calibration documentation, master data, maintenance plans and records.
• Review data integrity deliverables including audit trails and user access reviews.
• Support inspections and act as QA qualification representative.
• Review qualification documents: protocols, reports, procedures, rationales, discrepancies and CAPAs.
• Participate in system and process improvement initiatives while upholding quality requirements.

Connaissances

Quality awareness

GMP knowledge

Data management

Communication

Risk assessment

Analytical thinking

Collaboration

Formation

Master’s degree in engineering (chemistry/analytical)

Outils

Computerised systems

Description du poste

MindCapture is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. This consultancy role supports data integrity and change control while ensuring compliance with European and US cell therapy guidance.

You will collaborate with manufacturing and quality teams, prepare for inspections, and review protocols and reports as part of ongoing system and process improvements.