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Quality Assurance Specialist

2 mesi fa

Milano, Lombardia, Italia Viatris A tempo pieno
About the Role

Viatris is seeking a highly skilled Quality Assurance Support professional to join our team. As a Quality Assurance Support, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Manage complaints of products on the TW system, updating it according to new and further information, review of the relative investigations and response letters investigations, CAPAs, deviations on the system till closure;
  • Manage information requests about products;
  • Manage APQR/PQR of local and group products: requesting to the supplier, review, checking with the supplier for additional information if needed;
  • Collect relevant documentation from the suppliers to verify their compliance with E.I. Guideline ICH-Q3D impurities;
  • Manage change control on TWS system;
  • Manage Incident/investigation;
  • Support QA Officer to update Vendor List;
  • Sop management and D2 coordinator activities;
  • Perform any other duties as assigned.
About Your Skills and Experience

We are looking for a candidate with a strong background in quality assurance and regulatory compliance. The ideal candidate will have:

  • A minimum of a Bachelor's degree in a scientific field (or equivalent);
  • Knowledge of GMP, GDP, national pharmaceutical legislations (Decreto Legislativo n.219/2006);
  • Problem-solving and team-working skills;
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis;
  • Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
About Viatris

Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We do so by providing high-quality trusted medicines, advancing sustainable operations and innovative solutions to improve patient health, and leveraging our collective expertise to connect people to products and services.

We are committed to helping create healthier communities worldwide through education, outreach, and better access to treatment. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.

We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.