Head of Sterility Assurance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mq7n1

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:
Lead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives.
Ensure compliance of all Sterility Assurance activities with applicable GMP requirements, regulatory expectations, corporate quality standards,



and internal procedures.
Chair the global Sterility Assurance Committee, including the development of global SOPs, aseptic training programs, and oversight of Environmental Monitoring (EM) performance across the network.
Define and coordinate CAPAs related to Sterility Assurance, including those arising from health authority inspections, audits, deviations, and escalations.
Provide leadership and support during quality or compliance crisis situations.
Act as a subject matter expert, supporting site investigations and the definition and implementation of effective CAPAs.
Support the definition of User Requirement Specifications (URS) and validation strategies for new facilities, equipment, and production lines.
Define, prioritize, and coordinate global Sterility Assurance projects across the SHS Radiopharma network.
Conduct site visits and provide guidance to ensure consistent application of cGMP requirement

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mq7n1