Qualified Person
Pubblicato il 02-09-2026 - Siemens Mobility in Colleretto Giacosa
515837
31-Jul-2026
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. 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.
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.
Your role:
- Certify and release radiopharmaceutical batches in accordance with EU Directive 2001/83/EC and applicable national legislation.
- 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.
Your profile:
- Degree in Pharmacy or CTF (Chemistry and Pharmace