Quality Engineer

Panda International; Leiden; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Formation

Bachelor's degree or equivalent

Description du poste

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

Your 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.

What you bring

• A relevant HBO/bachelor’s degree or equivalent.
• At least 5 years of relevant pharmaceutical experience as a Quality Engineer, Investigation Lead or in a similar role.
• Hands-on experience with quality investigations, root-cause analysis, CAPA and change controls.
• Strong knowledge of GMP and quality documentation requirements.
• English proficiency at B2 level or above; Dutch is preferred.
• Strong analytical and communication skills, with a proactive approach to ownership and problem-solving.
• The ability to manage changing priorities, coordinate stakeholders and meet deadlines.
• Working arrangement: Hybrid, with 2 days on-site per week.
• Hours: 40 hours per week.
• Contract opportunity: Open to freelancers and employed consultants.