QA Qualification Engineer

MindCapture; Gent; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Expense allowance

Company car

Training & development

Résumé du poste

MindCapture seeks a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. In this consultancy role you will oversee qualification programs and ensure data integrity and change controls are managed to maintain compliant production assets.

You will collaborate with manufacturing and quality teams, support inspections, review protocols and reports, and contribute to continuous improvement initiatives.

Qualifications

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences.
• Strong GMP knowledge and regulatory guidance for cell therapy manufacturing (EU/US).
• Ability to defend qualification strategies and documentation during inspections.
• Experience with computerised systems and data management for critical assets.
• Excellent communication and cross-department collaboration in a changing environment.
• Fluency in Dutch and English (spoken and written).
• Analytical thinking with risk assessment and clear communication.
• 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 with corrective actions.
• Work with manufacturing stakeholders to review and approve change controls and quality-related deviations.
• Collaborate with quality functions to maintain qualification and compliance standards.
• Manage calibration documentation, master data, maintenance plans and records for critical assets.
• Review and approve data integrity deliverables including system audit trails and user access reviews.
• Support regulatory and customer inspections and act as a QA qualification representative.
• Review qualification documents including protocols, reports, procedures and corrective actions.
• Participate in system and process improvement initiatives while ensuring quality and compliance.

Connaissances

Strong communication skills

Analytical thinking

Risk assessment

Collaboration / teamwork

Formation

Master’s degree in engineering (chemistry/analytical) or pharmaceutical sciences

Outils

Computerised systems experience

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.

If MindCapture sees a potential fit, we’ll get in touch as soon as possible.

If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep your profile in mind for future roles that could suit you better.