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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Specialist (hybrid)


Reference:RK1559 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Specialist

Quality Assurance Specialist (hybrid)
RK1559
Contract 6 months
Dublin



We’re currently recruiting for an exciting opportunity with a leading global logistics organization supporting the pharmaceutical and life sciences sector in Dublin. This is an excellent role for anyone looking to join a world-class multinational known for its high standards and strong reputation in quality and compliance.



Duties:

  • Manage the preventative maintenance schedule and liaising with contractors to arrange site visits, follow up on reports and ensure appropriate documentation is received and internal logs are maintained.
  • Ensuring all appropriate qualifications are performed for activities undertaken under the WDA, e.g. temperature mapping, monitoring, validation, equipment validation, system validation, transport validation.
  • Liaising with contractors to arrange validations and site visits, peer reviewing protocols and reports and ensuring appropriate documentation is received and internal logs are maintained.
  • Ensuring that the warehouse/facility is successfully operated in keeping with GDP, including temperature management, and that any excursions/issues are addressed and reported on a timely basis (CAPA’s closed out correctly).
  • Drafting change controls and risk assessments in line with current EU and HPRA guidelines to ensuring a comprehensive and effective Quality Risk Management/Change Control & CAPA procedures is in place
  • Drafting and updating Quality Technical Agreements and supporting with the third-party supplier approval process
  • Support with managing the daily interfaces with supply chain, customer services and facility management to ensure all
  • medicinal product receipts and deliveries are made in keeping with GDP best practice and per SOPs.
  • Ensure that all records are completed in real time and to a high standard in keeping with SOP’s/Quality Systems.
  • Assist with updating operational work instructions and updating SOPs
  • Assist the quality team in ensuring that initial and continuous training programmes are updated, implemented and maintained.
  • Ensure that all relevant complaints are investigated in a timely manner. Ensure that such complaints are documented and followed up to ensure that all appropriate corrective actions are taken



Educational and Experience

  • University degree in an Engineering or Science-related discipline (preferred).
  • Over 2 years of relevant experience in the pharmaceutical or biotechnology industry
  • Experience with handling deviations, CAPAs, risk management, change control, validations, document authoring and control, temperature monitoring and temperature control
  • Familiar with EU GDP Regulation (2013/C/343/01)

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