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Quality Systems Specialist – Fixed Term

Dublin, Country: Ireland
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Job Description

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McDermott Laboratories Limited
Quality Systems Specialist – Fixed Term - 20001279
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 Quality Systems Specialist role will make an impact:

Key responsibilities for this role include:
  • Investigations into OOT Complaints for in-network and 3rd party complaints/issues notified to Viatris.
  • Ensure stability for in-network and 3rd party is scheduled and annual reports provided to QA for review.
  • Review of OOS for stability notified to Viatris by in-network/3rd party suppliers.
  • Review of 200+ in-network/3rd party PQRs for the release sites and notification to QA / QPs of any trends in Q that occur.
  • Review of RFT figures for in-network/3rd party supplier trends and work with 3rd party to assign CAPA.
  • Review all Audit reports for new suppliers for 3rd party product for Manufacturing License updates.
  • Implementation of Quality Risk Requirements (ICH Q9) required by QP release sites to support HA inspections for review of Quality Supply chain requirements.
  • Assist in change control coordination for external and in-network bulk and packed product for Viatris Ireland.
  • Assist in Technical Agreement coordination for outsourced product.
  • Support QA Manager for QA systems for Launch and 3rd party requirements.
The minimum qualifications for this role are:
  • 3rd level qualification in science related discipline.
  • Experience of Quality Systems in a Pharmaceutical environment would be of benefit.
  • Relevant experience in GMP/GLP environment.
  • Strong organisational skills / ability to prioritize work.
  • Proven track record as a team player.
  • High level of proficiency in Microsoft Word/Excel.
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.



Contract Type

Fixed Term

Job Posting

Dec 21, 2020, 8:27:59 AM

Unposting Date


Job Settings
Number of jobs: 1 hires
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Company: Mylan
Company size: 1-49
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