Experteer Italy
Quality Assurance Manager & Qualified Person
Job Location
colleretto-giacosa, Italy
Job Description
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Advanced Accelerator Applications, a Siemens Healthineers company, is a global leader in the production of PET radiotracers. With over two decades of expertise, we are committed to delivering high-quality, reliable diagnostic radiopharmaceuticals and services that have established us as a trusted partner in PET imaging. As part of Siemens Healthineers Molecular Imaging business, we are integrated into a global network of 60 radiotracer production facilities. Siemens Healthineers is the largest supplier of PET diagnostic radiopharmaceuticals, delivering approximately two million doses annually to more than 3,100 imaging centers worldwide. At Advanced Accelerator Applications, we believe in fostering an inclusive, diverse, and collaborative environment where every individual is valued. We encourage personal and professional growth, offering opportunities to step outside your comfort zone while providing the resources and flexibility to thrive. Join us to make a meaningful impact on global healthcare and be part of a team dedicated to shaping the future of medical imaging. Apply now for the position of Quality Assurance Manager & Qualified Person in Colleretto Giacosa, Turin. You will be responsible for maintaining the local quality management system as per GMP regulations and corporate guidelines, as well as overseeing all health-regulated activities to ensure compliance with external and internal requirements. As a Qualified Person, you will also be responsible for releasing batches of pharmaceutical products for human use in accordance with the European Union pharmaceutical regulation (Directive 2001/83/EC). Your role: You maintain and supervise the local quality system as per GMPs and corporate guidelines. You ensure that out-of-specifications, out-of-trend data, deviations, CAPA, and change controls are addressed and recorded according to cGMP and SOPs. You oversee the recall procedure in case of critical issues impacting the products, in compliance with GMPs and health authority requirements (AIFA and FDA). You release the batches of radiopharmaceuticals produced according to Directive 2001/83/EC and national laws. You certify production operations on appropriate documentation and are responsible for their maintenance and updates. Your expertise: Bachelor’s degree in a scientific field (e.g., chemistry, pharmacy, engineering, biology). At least 3 years of experience in the radiopharmaceutical or pharmaceutical industry. Ministerial Qualification as a Qualified Person. Strong communication, leadership, teamwork, and problem-solving skills. Good knowledge of English. To learn more about our business, visit Advanced Accelerator Applications Molecular Imaging - Siemens Healthineers . Who we are: We are a team of over 71,000 dedicated health professionals across more than 70 countries. As leaders in medical technology, we strive to create better outcomes and experiences for patients worldwide, supporting clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and specialists, all committed to contributing diverse ideas and innovations. We come from varied backgrounds and cultures, united in our purpose to pioneer healthcare breakthroughs for everyone, everywhere, sustainably. Learn more at Jobs at Siemens Healthineers . J-18808-Ljbffr
Location: colleretto-giacosa, IT
Posted Date: 6/26/2025
Location: colleretto-giacosa, IT
Posted Date: 6/26/2025
Contact Information
Contact | Human Resources Experteer Italy |
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