As Qualified Person, you hold legal responsibility for releasing radiopharmaceutical products in line with EU GMP, radiation safety, and marketing authorizations. You will work across Production, QC, QA and Radiation Safety to ensure product quality and regulatory compliance. You will prepare for inspections, review documentation, and lead investigations when needed. This role sits at the intersection of science, regulation, and patient safety. You will be part of a global leader advancing molecular imaging through robust quality and compliance.Certify and release radiopharmaceutical batches per EU Directive 2001/83/EC and national lawsEnsure manufacturing and QC activities comply with GMP and radiation safety regulationsReview and approve batch documentation, deviations, CAPAs, change controls, and investigationsCollaborate with Production, QC, QA,



and Radiation Safety teams to ensure quality and complianceAct as primary contact for product release during regulatory inspections and auditsMonitor regulatory developments and maintain site complianceParticipate in risk assessments and investigations involving radioactive materialsProvide expert GMP, quality, and regulatory guidance to internal stakeholdersEnsure personnel receive GMP and radiation safety trainingState Pharmacy Qualification required in ItalyFluent Italian and English, both written and spoken3 to 5 years in Quality Control and/or Quality Assurance within a GMP pharmaceutical environmentExperience in radiopharmaceuticals, sterile manufacturing, or aseptic processing desirableStrong knowledge of EU GMP regulations and pharmaceutical quality systemsExcellent analytical skills, attention to detail, and decision-making abilitiesStrong communication and stakeholder management in cross-functional settings #J-18808-Ljbffr

📌 Qualified Person - Radiopharmaceuticals (F/M/D) (Volpiano)
🏢 Experteer Italy
📍 Volpiano