GMP Quality Investigator | CAPA & Root-Cause Lead (Hybrid)

Panda International; Leiden; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Panda International is recruiting a Quality Engineer to support Janssen Biologics in Leiden. You will lead manufacturing quality investigations, identify root causes and drive corrective and preventive actions through to completion.

The role requires a relevant HBO/bachelor’s degree and 5+ years in pharmaceutical QA. Hybrid work with 2 on-site days per week, 40 hours, and flexibility for freelancers or employed consultants.

Qualifications

• HBO/bachelor’s degree or equivalent.
• 5+ years pharmaceutical QA experience as Quality Engineer or Investigation Lead.
• Experience with quality investigations, root-cause analysis, CAPA and change controls.
• Strong GMP knowledge and quality documentation requirements.
• English B2 or higher; Dutch preferred.

Responsibilities

• Own non-conformance investigations, CAPA records and change controls from initiation to closure.
• Coordinate cross-functional investigation teams and ensure quality records are completed accurately and on time.
• Investigate issues affecting manufacturing processes, products and systems, using data to identify root causes and practical solutions.
• Review operational documentation and update procedures following investigations, audits and regulatory changes.
• Implement risk mitigations and continuous quality improvements.
• Escalate risks relating to safety, product quality and regulatory compliance.
• Conduct regular GEMBA walks on the production floor to assess GMP adherence and support improvements.

Education

Bachelor's degree or equivalent

Job description

Panda International is recruiting a Quality Engineer to support Janssen Biologics in Leiden. You will lead manufacturing quality investigations, identify root causes and drive corrective and preventive actions through to completion.

The role requires a relevant HBO/bachelor’s degree and 5+ years in pharmaceutical QA. Hybrid work with 2 on-site days per week, 40 hours, and flexibility for freelancers or employed consultants.