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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Manager


Reference:RK5141 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Manager

Quality Assurance Manager (Onsite once a week)
RK5141
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Key Responsibilities:

  • Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA)
  • Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.
  • Owner and approver of GMP/GDP QMS documents
  • Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.
  • Preparation and periodic review of Bona Fides
  • QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
  • QA approval of change control proposals (third party contractors and internal) and action plans.
  • Coordinate mock recall task force team to test the recall process in accordance with governing procedures and issuance of report with recommendations and corrective action plans for any deficiencies identified.
  • Support OpEx programs and champion continuous improvements and initiatives



Education and Experience:
  • Bachelor’s Degree in a Science Field
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to oversee multiple projects simultaneously
  • Ability to travel +/- 10% of time to domestic and international sites


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.