QA Qualification Engineer

MindCapture BV; Beerse; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

meal vouchers

eco vouchers

DKV health insurance

group insurance

net expense allowance

company car

Job summary

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.

Responsibilities

• 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.

Skills

Quality assurance

GMP compliance

Data integrity

Change controls

CAPA investigations

Cross-functional collaboration

Documentation

Education

Master’s degree in engineering

Pharmaceutical sciences

Tools

Computerised systems

Job description

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.

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

What's offered?

We offer competitive salaries.

• meal vouchers
• eco vouchers
• DKV health insurance
• group insurance
• net expense allowance
• 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.