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Quality Systems Specialist – Fixed Term

Company:
Mylan
Location:
Dublin, Country: Ireland
Job Type:
Job Description

Primary Location

IRE-Leinster-Dublin

Organization

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.

Schedule

Full-time

Contract Type

Fixed Term

Job Posting

Dec 21, 2020, 8:27:59 AM

Unposting Date

Ongoing

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Mylan
Company size: 1-49
Contact: NA