QA Qualification Engineer

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

Drive quality and compliance for advanced cell therapy manufacturing as a QA C and Q Engineer. In this consultancy role, you will oversee qualification activities for critical facilities, utilities and process equipment while supporting a highly regulated manufacturing environment.

Ready to grow your career and make real impact? Join MindCapture as a QA Qualification Engineer and contribute to impactful healthcare projects in a GMP environment.

What's offered?

Ready to grow your career and make real impact? Join MindCapture!

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car). You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths and make a difference where it matters most.

You will work as a MindCapture consultant for an international market leader in the pharma industry.

Job Description:

• 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

Requirements:

• 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

Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in Pharma.