Senior QA Engineer

Our client, a leading organization in the medical radioisotope sector, is looking for an experienced professional to support the start-up of a new production facility. The role focuses on establishing quality systems and ensuring operational procedures are compliant and audit-ready before production commences.

• Develop and draft operational QA procedures including training, supplier qualification, internal audits, and product release.
• Conduct supplier qualification audits and assessments to ensure compliance with quality standards.
• Review validation plans, protocols, tests, and reports for equipment, systems, analytical methods, and clean room environments.
• Review operational documentation such as material specifications and incoming goods inspection protocols.
• Manage the issuance of controlled copies, including batch records.
• Verify compliance with GMP guidelines, specifically Annex 1, Annex 3, and Annex 11 / FDA 21 CFR Part 11.
• Provide advisory support to the project team regarding GMP compliancy and audit readiness.

• You bring 10+ years of relevant experience in a GMP environment focusing on QA and validation.
• You possess a Master’s degree in a scientific field such as Engineering, Chemistry, Biomedical Sciences, or Pharmacy.
• You have extensive knowledge of GMP guidelines, specifically Annex 1 (sterile products) and Annex 3 (radiopharmaceuticals).
• You have proven experience setting up and implementing entirely new QA processes.
• You're experienced with computerized system validation and data integrity standards like Annex 11 and FDA 21 CFR Part 11.
• You are native or fluent in both Dutch and English (C2 level).
• You are proactive, hands-on, and possess the discipline to drive projects through to successful validation.
• You're willing to perform inspections in controlled environments where radioactive materials are processed.

Nice to Haves

• Experience with the start-up phase of a new production facility.

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