Qualified Person - Radiopharmaceuticals (f/m/d)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7aumz9

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

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7aumz9