Quality Assurance GMP Netherlands

Resourcing Life Science Ltd.; Netherlands; On-site; EUR 70,000 - 90,000; Full time

Job summary

Resourcing Life Science Ltd. is seeking a Quality Assurance professional to ensure GMP compliance across manufacturing and finished products. You will review SOPs, assess documentation, and investigate incidents to drive CAPAs and improvements.

You will coordinate internal and external audits, prepare annual quality reviews, and support cross-functional teams with quality discussions and agreements. A strong GMP background and 5+ years in pharma/biotech are required.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• At least five years of Quality Assurance experience / GMP-regulated environment in pharma/biotech.
• Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system.

Responsibilities

• Maintain GMP compliance across manufacturing processes and finished products.
• Review and update SOPs, work instructions and quality documentation.
• Assess production and batch documentation for accuracy and compliance.
• Investigate quality incidents and deviations, implement corrective and preventive actions.
• Manage customer complaints and coordinate CAPAs.
• Plan and perform internal audits; document findings and improvements.
• Coordinate external audits and inspections, including responses and follow-up.
• Compile annual product quality reviews and report on quality system performance.
• Support quality discussions with internal teams and partners; review quality agreements.
• Advise production teams on quality requirements and promote GMP awareness.

Skills

GMP knowledge

CAPA system

Audit experience

Education

Bachelor’s or Master’s degree in a scientific/technical field

Job description

Your responsibilities

• Maintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products.
• Review, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations.
• Assess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements.
• Investigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively.
• Manage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs.
• Plan and perform internal audits, document findings and ensure agreed improvements are completed.
• Coordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities.
• Compile annual product quality reviews, assess quality system performance and prepare required reports and management information.
• Support quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements.
• Advise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization.
• Identify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting.

Your profile

• A bachelor’s or master’s degree in a relevant scientific or technical discipline.
• At least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech
• Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system