Quality Assurance Specialist
4 settimane fa
Quality Assurance Support Role
Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are seeking a Quality Assurance Support to join our team.
The Quality Assurance Support will be responsible for managing complaints of products on the TW system, updating it according to new and further information, reviewing relative investigations and response letters investigations, CAPAs, deviations on the system till closure.
Key responsibilities for this role include:
- Manage complaints of products on 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 info requests about products;
- Manage APQR/PQR of local and group products: requesting to the supplier, review, checking with the supplier for additional info 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.
The minimum qualifications for this role are:
- Minimum of a Bachelor's degree preferably in Scientific Field (or equivalent);
- Knowledge of GMP, GDP, national pharmaceutical legislations (Decreto Legislativo n.219/2006);
- Problem solving and team working;
- 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.
Viatris offers 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.
Viatris is an Equal Opportunity Employer.
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