p p31-Jul-**** /p pSiemens Healthineers /p pQuality Management /p pMid-level Professional /p pAt Siemens Healthineers (SHS) Radiopharma, we are committed to driving sustainable progress through cutting-edge technology.
We empower our customers by bridging the physical and digital worlds—enhancing the way we live, work, and move, today and for future generations.
/p pWe believe that business success begins with our people.
That's why we prioritize a culture where individuals thrive.
Our diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways.
Together, there are limitless possibilities of where our shared journey may lead.
/p pAs the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, SHS Radiopharma pioneered the commercial PET radiopharmacy model over 30 years ago—and continues to shape the future of molecular imaging.
/p h3Your role: /h3 ul liCertify and release radiopharmaceutical batches in accordance with EU Directive *******/EC and applicable national legislation.
/li liEnsure manufacturing and quality control activities comply with GMP requirements and radiation safety regulations.
/li liReview and approve batch documentation, deviations, CAPAs, change controls, and quality investigations.
/li liCollaborate closely with Production, Quality Control, Quality Assurance, and Radiation Safety teams to ensure product quality, integrity, and compliance.
/li liAct as the primary contact for product release activities during regulatory inspections and customer audits.
/li liMonitor regulatory developments and ensure continued site compliance with applicable requirements.
/li liParticipate in risk assessments and investigations involving radioactive materials.
/li liProvide expert advice on GMP, quality, and regulatory topics to internal stakeholders.




/li liEnsure personnel involved in manufacturing and quality control activities receive appropriate GMP and radiation safety training.
/li /ul h3Your profile: /h3 ul liDegree in Pharmacy or CTF (Chemistry and Pharmaceutical Technology).
/li liState Pharmacy Qualification required in Italy.
/li liFluent Italian and English, both written and spoken.
/li li3 to 5 years of experience in Quality Control and/or Quality Assurance within a GMP-regulated pharmaceutical environment.
/li liExperience in radiopharmaceuticals, sterile manufacturing, or aseptic processing is highly desirable.
/li liStrong knowledge of EU GMP regulations and pharmaceutical quality systems.
/li liExcellent analytical skills, attention to detail, and ability to make quality-critical decisions.
/li liStrong communication and stakeholder management skills within a cross-functional environment.
/li /ul h3Who we are: /h3 pWe are a team of more than 74,000 highly dedicated Healthineers in more than 70 countries.
As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.
Our portfolio is crucial for clinical decision-making and treatment pathways.
/p h3How we work: /h3 pWhen you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas.
We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare.
For everyone.
Everywhere.
Sustainably.
/p pAs an equal opportunity employer, we welcome applications from individuals with disabilities.
/p pWe care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.
For this reason, we ask you not to send us your CV or resume by email.
/p /p #J-*****-Ljbffr

📌 Qualified Person - Radiopharmaceuticals (F/M/D) (Montà)
🏢 Siemens Mobility
📍 Montà