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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior QA Associate (shift)


Reference:RK35092 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior QA Associate (shift)
RK35092
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.



This 24/7 shift role demands a 12-hour shift pattern (4 on, 4 off) to support manufacturing operations.



Key Responsibilities:

  • Ensure adherence to safety standards and SOPs in all activities.
  • Review and approve production batch records and associated documentation for Qualified Person disposition activities.
  • Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
  • Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
  • Offer Quality Assurance support for on-the-floor investigations and deviations.
  • Review and approve deviations for closure, ensuring compliance with appropriate documentation.
  • Participate in customer complaint investigations.
  • Conduct routine Quality Assurance walks on the production floor.
  • Review and issue logbooks, ensuring compliance with procedures.
  • Provide training and guidance to staff for effective performance.
  • Review and approve cGMP records, ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.
  • Undertake other tasks/projects as assigned by the manager.


Education and Experience:
  • University degree in an Engineering or Science-related discipline (preferred).
  • Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.
  • Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
  • Competent in the use of MES, Trackwise and SAP


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