QA Qualification Engineer

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.