Quality Investigation Engineer - CAPA & GMP Lead

Sire Search; Leiden; On-site; EUR 70,000 - 90,000; Full time

Job summary

Sire Search in the Netherlands is seeking a Quality Engineer (Investigation Owner) to lead and manage quality investigations across manufacturing processes, products, and systems. You will identify root causes, drive CAPA actions, and ensure regulatory and internal standards are met.

The role requires collaboration with cross-functional teams, documentation of findings, and implementation of process improvements. Strong analytical thinking and stakeholder communication are essential.

Qualifications

• HBO degree with relevant quality investigations experience in pharma.
• Proven ability to lead root cause investigations and CAPA.
• Strong documentation and data-analysis skills.

Responsibilities

• Lead root cause investigations of non-conformances and quality issues, including managing CAPA records and change controls from initiation to completion.
• Review and support documentation associated with manufacturing processes and activities.
• Maintain and update procedures and quality records, ensuring compliance with regulatory requirements.
• Initiate and support risk mitigation initiatives and continuous quality improvement projects.
• Support formal escalation processes related to safety, product quality, and regulatory compliance risks.
• Conduct GEMBA walks regularly to observe GMP adherence, identify areas for improvement, and implement corrective actions.
• Assemble and lead teams for quality record management, escalating issues as needed, and maintaining high professional standards.

Skills

Root cause analysis

CAPA management

Change controls

Regulatory compliance

Documentation

GEMBA walks

Quality records

Stakeholder communication

Analytical thinking

Prioritization

Education

HBO degree

Tools

MS Office

Data analysis tools

Job description

Sire Search in the Netherlands is seeking a Quality Engineer (Investigation Owner) to lead and manage quality investigations across manufacturing processes, products, and systems. You will identify root causes, drive CAPA actions, and ensure regulatory and internal standards are met.

The role requires collaboration with cross-functional teams, documentation of findings, and implementation of process improvements. Strong analytical thinking and stakeholder communication are essential.