Qualified Person

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7e6jms

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 laws
Ensure manufacturing and QC activities comply with GMP and radiation safety regulations
Review and approve batch documentation, deviations, CAPAs, change controls, and investigations
Collaborate with Production, QC, QA, and Radiation Safety teams to ensure quality and compliance
Act as primary contact for product release during regulatory inspections and audits




Monitor regulatory developments and maintain site compliance
Participate in risk assessments and investigations involving radioactive materials
Provide expert GMP, quality, and regulatory guidance to internal stakeholders
Ensure personnel receive GMP and radiation safety training
State Pharmacy Qualification required in Italy
Fluent Italian and English, both written and spoken
3 to 5 years in Quality Control and/or Quality Assurance within a GMP pharmaceutical environment
Experience in radiopharmaceuticals, sterile manufacturing, or aseptic processing desirable
Strong knowledge of EU GMP regulations and pharmaceutical quality systems
Excellent analytical skills, attention to detail, and decision-making abilities
Strong communication and stakeholder management in cross-functional settings
J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7e6jms