Qualified Person (Italia)

Qualified Person (Italia)

13 ago
|
Siemens Mobility
|
Italia

13 ago

Siemens Mobility

Italia

Siemens Healthineers
Quality Management
Mid-level Professional
At 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.
We believe that business success begins with our people. Our diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways. As 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.
Ensure manufacturing and quality control activities comply with GMP requirements and radiation safety regulations.
Review and approve batch documentation, deviations, CAPAs, change controls, and quality investigations.
Collaborate closely with Production, Quality Control, Quality Assurance, and Radiation Safety teams to ensure product quality, integrity, and compliance.




Act as the primary contact for product release activities during regulatory inspections and customer audits.
Monitor regulatory developments and ensure continued site compliance with applicable requirements.
Participate in risk assessments and investigations involving radioactive materials.
Provide expert advice on GMP, quality, and regulatory topics to internal stakeholders.
Ensure personnel involved in manufacturing and quality control activities receive appropriate GMP and radiation safety training.
Degree in Pharmacy or CTF (Chemistry and Pharmaceutical Technology).
~ State Pharmacy Qualification required in Italy.
~ Fluent Italian and English, both written and spoken.
~3 to 5 years of experience in Quality Control and/or Quality Assurance within a GMP-regulated pharmaceutical environment.
~ Experience in radiopharmaceuticals, sterile manufacturing, or aseptic processing is highly des

📌 Qualified Person (Italia)
🏢 Siemens Mobility
📍 Italia

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