Key Skills

Job Description

Quality Engineer (Investigation Owner) | Leiden, Netherlands | 12-Month Contract 🚀 We are currently looking for an experienced Quality Engineer (Investigation Owner) to join a leading international pharmaceutical organization in the Leiden area. In this role, you will be responsible for leading quality investigations, driving root cause analysis, managing CAPA activities, and ensuring compliance with GMP and regulatory requirements. You will work closely with cross-functional stakeholders to maintain the highest quality standards while supporting continuous improvement initiatives within a manufacturing environment. Key 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 What We're Looking For ✔ HBO degree or equivalent in a relevant scientific or engineering discipline ✔ Minimum 5 years of experience in a Quality Engineering, Investigation Lead, or similar GMP-regulated role ✔ Pharmaceutical or biotech industry experience is essential ✔ Strong knowledge of deviation investigations, CAPA, and Change Control processes ✔ Experience working within GMP-regulated manufacturing environments ✔ Strong analytical and problem-solving skills with the ability to identify root causes and develop sustainable solutions ✔ Ability to manage multiple priorities and work effectively in a fast-paced environment ✔ Professional communication skills and stakeholder management experience ✔ Fluency in English (minimum B2 level) Contract Details 📍 Location: Leiden, Netherlands 📅 Duration: 12-month contract 🏢 Industry: Global Pharmaceutical Manufacturing Interested? If you have a strong quality background within the pharmaceutical industry and enjoy owning investigations while driving continuous improvement, I'd love to hear from you.

Core Responsibilities

Lead non-conformance investigations from initiation through closure, perform root cause analysis, and manage CAPA records and Change Controls. Maintain compliant manufacturing quality documentation, support continuous improvement and risk mitigation, monitor GMP adherence on the production floor, and communicate outcomes to stakeholders.

Requirements

Requires an HBO degree or equivalent in a relevant scientific or engineering discipline and at least five years of experience in a quality or investigation role within a GMP-regulated pharmaceutical or biotech environment. Candidates should have strong knowledge of investigations, CAPA, and Change Control, along with analytical, problem-solving, prioritization, and stakeholder communication skills; English proficiency at B2 level or higher is required.