Quality Engineer

Quality & Validation Management. Profiel van de geschikte interim professional: Background in QMS, deviations, non-conformances, CAPAs and change control; Insight into manufacturing operations, preferably USP and/or DSP; Solid skills in technical writing and documentation; Background in root cause analysis and managing investigations; Familiarity with COMET, TrackWise or Veeva is a plus; Pharmaceutical or biotechnology manufacturing experience preferred; food industry experience also considered; Strong capabilities in analysis, organization and stakeholder management; Availability for two days per week onsite, with extra onsite presence during onboarding.

Taken & verantwoordelijkheden: As Quality Engineer you support GMP compliance and quality investigations within manufacturing operations. Lead deviation and non-conformance investigations from start to closure; Manage CAPAs and change controls to ensure timely, compliant completion; Perform root cause analysis, including the Fishbone method; Check and keep quality records, procedures and technical documentation up to date; Liaise with Operations, Engineering, MSAT and QA; Spot risks and roll out corrective measures and quality enhancements; Support GMP compliance through floor observations and GEMBA walks; Flag quality risks upward and share investigation outcomes with stakeholders.