Quality Engineer (Investigation Owner)Start date: ASAPDuration: 6 months + likely extensionOpenings: 3Language: EnglishDescriptionThe Quality Engineer (Investigation Owner) leads quality investigations into manufacturing processes, products and systems within a pharmaceutical operations unit. The role identifies root causes, drives CAPA and change controls through to completion, and ensures compliance with GMP and regulatory requirements.ResponsibilitiesLead non-conformance investigations and identify root causes of quality issues.Own CAPA records and change controls for the operations unit from initiation through completion.Assemble and lead the cross-functional teams required for quality records.Review documentation associated with operations unit processes and products.Maintain and update procedures in line with new regulatory requirements, investigations and audits.Ensure compliant documentation and timely closure of quality records.Initiate risk mitigations and continuous improvement projects with limited guidance.Escalate risks to safety, product quality and regulatory compliance through formal processes.Perform regular GEMBA walks to verify GMP adherence on the production floor and drive corrective actions.Essential RequirementsRelevant HBO (Bachelor’s) degree.5+ years’ experience as an Investigation Lead, Quality Engineer or similar role in the pharmaceutical industry.Hands-on experience with deviations/non-conformances, root cause analysis, CAPA and change control.Strong working knowledge of GMP.English at B2 level or higher.Specialist-level use of quality business applications, intermediate MS Office and routine data analysis.Preferred RequirementsExperience leading investigations in a manufacturing or operations environment.Structured root cause tools such as 5 Whys, Ishikawa or FMEA.Experience with eQMS systems such as TrackWise or Veeva.Continuous improvement or Lean experience.Dutch language skills.

Sourced from LinkedIn. Relocantly aggregates public job postings; apply on the original site.