Investigations Specialist

MindCapture BV; Oost-Vlaanderen; Presencial; EUR 70 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Personalised training and development

Resumo da oferta

MindCapture BV is seeking a highly skilled MSAT professional to own GMP investigations and strengthen manufacturing processes in a life sciences setting. You will lead root cause analyses, CAPA implementations, and support regulatory inspections across cell and gene therapy manufacturing.

The role requires strong technical communication, collaboration with Quality, Engineering and Operations, and deep knowledge of GMP, process validation, and continuous improvement.

Qualificações

• Experience leading GMP manufacturing investigations.
• Experience with root cause analysis and CAPA implementation.
• Experience supporting GMP regulatory inspections and compliance activities.
• Understanding of process robustness, process validation and manufacturing operations.
• Experience with deviations, investigations, CAPAs and quality management systems.
• Strong technical and interpersonal communication skills.
• Full professional proficiency in English.
• Dutch language skills are considered an advantage.

Responsabilidades

• Define investigation strategies and drive root cause identification.
• Support CAPA implementation related to manufacturing processes.
• Maintain process knowledge and oversight of cell and gene therapy manufacturing processes.
• Troubleshoot complex scientific and technical manufacturing issues.
• Support regulatory inspections and investigation related responses.
• Apply risk assessment methodologies and assess product quality impact.
• Identify recurring deviations, analyse trends and support process improvements.
• Support technical feasibility studies for manufacturing technologies and automation.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain and other functions.
• Support process validation, technical transfer and manufacturing operations.

Conhecimentos

GMP investigations

Root cause analysis

CAPA implementation

Cell and gene therapy manufacturing

Regulatory inspections

Quality management systems

Process validation

Cross-functional collaboration

English proficiency

Dutch advantage

Descrição da oferta de emprego

Ready to take ownership of complex GMP investigations and strengthen manufacturing processes in an advanced life sciences environment? Join MindCapture and use your MSAT expertise to support quality, compliance and continuous improvement.

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 healthcare industry.

Job Description:

• Define investigation strategies and drive root cause identification
• Support CAPA implementation related to manufacturing processes
• Maintain process knowledge and oversight of cell and gene therapy manufacturing processes
• Troubleshoot complex scientific and technical manufacturing issues
• Support regulatory inspections and investigation related responses
• Apply risk assessment methodologies and assess product quality impact
• Identify recurring deviations, analyse trends and support process improvements
• Support technical feasibility studies for manufacturing technologies and automation
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain and other functions
• Support process validation, technical transfer and manufacturing operations

Requirements:

• Experience with cell and gene therapy manufacturing processes
• Experience leading GMP manufacturing investigations
• Experience with root cause analysis and CAPA implementation
• Experience supporting GMP regulatory inspections and compliance activities
• Understanding of process robustness, process validation and manufacturing operations
• Experience with deviations, investigations, CAPAs and quality management systems
• Strong technical and interpersonal communication skills
• Full professional proficiency in English
• Dutch language skills are considered an advantage

Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in biotechnology.

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.