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Quality Systems Specialist – Fixed Term
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.
Dec 21, 2020, 8:27:59 AM
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