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.