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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Systems Specialist


Reference:RK22464 Location: Tipperary
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Auditor

Quality Systems Specialist
RK22464
Contract – 11 months
Tipperary

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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.

Duties:

  • Act as Quality SME for Process, Cleaning, Water, Equipment and Change Control systems.
  • Lead validation activities and serve on site committees (PVC, CVG, WVC, EQVC).
  • Oversee laboratory QA activities including incidents, stability reports, GLIMS and microbiology liaison.
  • Manage critical systems including Annual Product Reviews, Quality Agreements, Supplier Change Evaluations, and Returned Goods.
  • Approve validation documentation, participate in regulatory inspections, and ensure filing/licence maintenance.
  • Maintain the integrity of site documentation for regulatory submissions and product filings.
  • Drive GMP compliance and continuous improvement initiatives through internal audits and cross-functional collaboration.


Experience and Education:

  • Degree or post-graduate qualification in Science, Pharmacy or Engineering field
  • 3+ years’ experience, ideally in Quality within the Biological and/or pharmaceutical industry.
  • Demonstrated experience with Change Control, Equipment/Process Validation, Laboratory QA, and System Ownership.
  • Familiarity with SAP, GLIMS, and document control systems.


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