Senior Quality Assurance Manager

Mylan (Dublin, Ireland) 3 days ago

Primary Location: IRE-Leinster-Dublin

Organization: Rottapharm Limited

At Viatris, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Manager role will make an impact:

Key responsibilities for this role include:Support, review and develop GMP systems on site and administer the change control systems in accordance with the relevant SOPs.Support, review and develop GMP systems on site and administer the change control systems in accordance with the relevant SOPs.
  • Support, review and develop GMP systems on site and administer the change control systems in accordance with the relevant SOPs.
  • Administer and co-ordinate the deviation reporting system in accordance with the relevant SOPs.
  • Review monthly reports for pest management system and ensure corrective actions are implemented as appropriate.
  • Manage regulatory and customer inspections associated with Company business.
  • Review investigate and closeout of product complaints as per the product complaint SOP.
  • Overall responsibility for the on hold and reject system.
  • Ensure that manufacturing license for the site is updated as appropriate and ensure all batches are reviewed effectively before product release.
  • Ensure adequate reference samples and appropriate records are archived for all products shipped.
  • Manage the preparation of annual product review reports as per the relevant SOP.
  • Maintain and co-ordinate the approved supplier qualification program.
  • Publish and maintain the internal audit schedule. To execute this calendar of events including reporting and close out of all issues.
The minimum qualifications for this role are:
  • 3rd level qualification in BSc required, MSc desirable
  • Minimum of 5 years GMP/Pharmaceuticals experience
  • QP qualified desirable but not critical
  • Strong people management skills and experience
At Viatris, 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.

Other Locations:

Schedule: Full-time

Permanent

Job Posting: Jan 18, 2021, 11:21:59 AM

Unposting Date: Ongoing

Senior Quality Assurance Manager

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