Quality Assurance Specialist (Logistics)
Quality Assurance Specialist (hybrid)
RK****
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 liaise with contractors to arrange site visits, follow up on reports and ensure appropriate documentation is received and internal logs are maintained.
Ensure all appropriate qualifications are performed for activities undertaken under the WDA, e.g., temperature mapping, monitoring, validation, equipment validation, system validation, transport validation.
Liaise with contractors to arrange validations and site visits, peer-review protocols and reports, and ensure appropriate documentation is received and internal logs are maintained.
Ensure 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).
Draft change controls and risk assessments in line with current EU and HPRA guidelines to ensure a comprehensive and effective Quality Risk Management/Change Control & CAPA procedures are in place.
Draft and update Quality Technical Agreements and support 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 SOPs/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, 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 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 *****/C/******).
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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