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

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
- 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 Specialist & Deputy Qualified Person. As QA Specialist, 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

• Assure the respect of the GMPs and Health Authorities requirements at local level.
• Perform batch release, ensuring that each batch has been manufactured in full compliance with the EU GMP requirements and those on the Marketing Authorization.
• Assure the execution of qualification, maintenance, calibration and revalidation programs at local level.
• Manage OOS, OOT, deviations, CAPA, Change controls and complaints.
• Manage other QMS topics such as local training, SOPs, annual product reviews,
  - inspections plan and suppliers' qualifications.
• Actively collaborate in Competent Authorities’ Inspections and
  - party audits.
• Assure ALCOA+ principles are applied in all Gx
  P documents.

Qualifications

• Eligible to act as a Qualified Person, holding the Industry Specialist Certificate issued by the Portuguese Pharmaceutical Society.
• Country language. English: fluent spoken and writing.
• More than 2 years of expertise in Quality Assurance Department and knowledge of GMP normative.
• Open and clear collaboration and communication to make sure the daily operation runs smoothly.
• Shows the appropriate sense of urgency around given tasks.
• Able to work and take decisions under pressure.
• Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system.

Additional information

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 Healthineers in more than 70 countries, united by a shared purpose to pioneer breakthroughs in healthcare. We are committed to equal opportunity and welcome applicants from diverse backgrounds.

How we work: When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists who believe in each individual’s potential. We foster diversity and collaboration to fight diseases and enable access to care. Check our Careers Site at https://www.siemens-healthineers.com/es/careers.

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