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

• University degree in an Engineering or Science-related discipline (preferred).
• Over 2 years of relevant experience in the pharmaceutical or biotechnology industry with an understanding of Good Distributions Practices
• 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)