Quality Assurance Manager & Deputy Qualified Person (m / f / d)

Overview

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 & Deputy Qualified Person, and as QA Manager, you will maintain the local quality management system according to GMP regulations and corporate guidelines, ensuring compliance with all internal and external requirements. As Deputy Qualified Person, you will ensure that each batch of medicinal products complies with EU GMP standards and applicable marketing authorizations.

Responsibilities

• You will assure the respect of the GMPs and Health Authorities requirements at local level.
• You will assure the execution of qualification, maintenance, calibration and revalidation programs at local level.
• You will manage OOS, OOT, deviations, CAPA, Change controls and complaints.
• You will perform batch release, ensuring that each batch has been manufactured in full compliance with the EU GMP requirements and those on the Marketing Authorization.
• You will actively collaborate in Competent Authorities' Inspections and third-party audits.
• You will assure ALCOA+ principles are applied in all GxP documents.

Qualifications

About the business

To find out more about the specific business, have a look at Advanced Accelerator Applications Molecular Imaging - Siemens Healthineers

Who we are

We are a team of more than 71,000 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.

How we work

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. Check our Careers Site at

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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