Quality Investigation Lead — GMP/CAPA

DPS Group Global; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

DPS Group Global is looking for a Quality Engineer (Investigation Owner) in Leiden to lead quality investigations, drive root cause analysis, and manage CAPA activities within a GMP-regulated pharmaceutical setting.

You will work with cross-functional teams, ensuring compliant documentation and effective corrective actions, while contributing to continuous improvement on the production floor.

Qualifications

• HBO degree in science or engineering with relevant background.
• Minimum 5 years in Quality Engineering, Investigation Lead or GMP-regulated role.
• Pharmaceutical or biotech experience is essential.
• Fluency in English (B2 or higher).
• Strong knowledge of deviation investigations, CAPA, and Change Control.

Responsibilities

• Lead non-conformance investigations from initiation through closure.
• Own and manage CAPA records and Change Controls (CC).
• Perform root cause analysis and implement effective corrective and preventive actions.
• Review and maintain quality documentation for manufacturing operations.
• Ensure timely and compliant completion of quality records.
• Support quality improvement initiatives and risk mitigation activities.
• Participate in formal escalation processes related to product quality, safety, and compliance.
• Conduct regular GEMBA walks on the production floor to monitor GMP adherence and identify improvement opportunities.
• Collaborate with cross-functional teams and communicate investigation outcomes to key stakeholders.

Skills

Analytical skills

Root cause analysis

Stakeholder management

Communication

Problem-solving

Education

HBO degree in science/engineering

Tools

CAPA

Change Control

GEMBA walks

Job description

DPS Group Global is looking for a Quality Engineer (Investigation Owner) in Leiden to lead quality investigations, drive root cause analysis, and manage CAPA activities within a GMP-regulated pharmaceutical setting.

You will work with cross-functional teams, ensuring compliant documentation and effective corrective actions, while contributing to continuous improvement on the production floor.