11 ago
|
Ith Icoserve
|
Montà
11 ago
Ith Icoserve
Montà
ppJob ID /p pPosted since /pp31-Jul-**** /ppField of work /ppQuality Management /ppCompany /ppMid-level Professional /ppJob type /ppFull-time /ppOffice/Site only /ppEmployment type /ppPermanent /ppLocation(s) /ppAt 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.
/ppWe 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.
/ppAs 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.
/ppbQualified Person (QP) /b, and take legal responsibility for ensuring that radiopharmaceutical products are manufactured, tested, and released in full compliance with EU GMP requirements, radiation safety regulations, and Marketing Authorization requirements before being supplied for clinical or commercial use.
/ppbCompensation: /b €39,000 - €52,000 base salary + benefits /ppbYour role: /b /pulliCertify and release radiopharmaceutical batches in accordance with EU Directive *******/EC and applicable national legislation.
/liliEnsure manufacturing and quality control activities comply with GMP requirements and radiation safety regulations.
/liliReview and approve batch documentation, deviations, CAPAs, change controls, and quality investigations.
/liliCollaborate closely with Production, Quality Control, Quality Assurance, and Radiation Safety teams to ensure product quality, integrity, and compliance.
/liliAct as the primary contact for product release activities during regulatory inspections and customer audits.
/liliMonitor regulatory developments and ensure continued site compliance with applicable requirements.
/liliParticipate in risk assessments and investigations involving radioactive materials.
/liliProvide expert advice on GMP, quality, and regulatory topics to internal stakeholders.
/liliEnsure personnel involved in manufacturing and quality control activities receive appropriate GMP and radiation safety training.
/li /ulpbYour profile: /b /pulliDegree in Pharmacy or CTF (Chemistry and Pharmaceutical Technology).
/liliState Pharmacy Qualification required in Italy.
/liliFluent Italian and English, both written and spoken.
/lili3 to 5 years of experience in Quality Control and/or Quality Assurance within a GMP-regulated pharmaceutical environment.
/liliExperience in radiopharmaceuticals, sterile manufacturing, or aseptic processing is highly desirable.
/liliStrong knowledge of EU GMP regulations and pharmaceutical quality systems.
/liliExcellent analytical skills, attention to detail, and ability to make quality-critical decisions.
/liliStrong communication and stakeholder management skills within a cross-functional environment.
/li /ulpbWho we are: /bbr/We 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.
/ppbHow we work: /bbr/When 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.
/ppAs an equal opportunity employer, we welcome applications from individuals with disabilities.
/p /p #J-*****-Ljbffr
📌 Qualified Person - Radiopharmaceuticals (F/M/D) (Montà)
🏢 Ith Icoserve
📍 Montà