Quality Assurance Specialist

Quality Assurance Specialist (hybrid)RK1559Contract 6 monthsDublin 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 placeDrafting and updating Quality Technical Agreements and supporting with the third-party supplier approval processSupport with managing the daily interfaces with supply chain, customer services and facility management to ensure allmedicinal 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 SOPsAssist 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 ExperienceUniversity degree in an Engineering or Science-related discipline (preferred).Over 2 years of relevant experience in the pharmaceutical or biotechnology industryExperience with handling deviations, CAPAs, risk management, change control, validations, document authoring and control, temperature monitoring and temperature controlFamiliar 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.