ppAs 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. /pulliCertify and release radiopharmaceutical batches per EU Directive 2001/83/EC and national laws /liliEnsure manufacturing and QC activities comply with GMP and radiation safety regulations /liliReview and approve batch documentation, deviations, CAPAs, change controls, and investigations /liliCollaborate with Production, QC, QA,



and Radiation Safety teams to ensure quality and compliance /liliAct as primary contact for product release during regulatory inspections and audits /liliMonitor regulatory developments and maintain site compliance /liliParticipate in risk assessments and investigations involving radioactive materials /liliProvide expert GMP, quality, and regulatory guidance to internal stakeholders /liliEnsure personnel receive GMP and radiation safety training /liliState Pharmacy Qualification required in Italy /liliFluent Italian and English, both written and spoken /lili3 to 5 years in Quality Control and/or Quality Assurance within a GMP pharmaceutical environment /liliExperience in radiopharmaceuticals, sterile manufacturing, or aseptic processing desirable /liliStrong knowledge of EU GMP regulations and pharmaceutical quality systems /liliExcellent analytical skills, attention to detail, and decision-making abilities /liliStrong communication and stakeholder management in cross-functional settings /li /ul /p #J-18808-Ljbffr

📌 Qualified Person - Radiopharmaceuticals (f/m/d) (Torino)
🏢 Experteer Italy
📍 Torino