Quality Specialist

Quality Specialist 12-Month Fixed-Term Contract Citywest/Greenogue The role To support the good distribution activities and go-live of the Greenogue 2 facility. Work with the quality, operations, and commercial teams to ensure effective and efficient processes are in place and to ensure that all operations are compliant with GxP standards. This position is a 12 month fixed-term contract. Key Outcomes Assisting with the management of query tickets around returns and complaints. Monitoring the Temperature System (EMS) and printing weekly warehouse temperature reports for the RP/DRP review. Creation and Review of quality-related procedures and quality documentation within the Quality Management System. Assisting with the raising and investigation of Deviations and Non-Conformances within the Quality Management System. Support the business in the daily duties associated with rework activities. Assisting RP with documenting appropriate site-specific CAPAs and change controls. Assist with GDP and procedure-based training. Generation and review of risk assessments. Reporting of exempt medicines products to the HPRA. Supporting regulatory and supplier audits. Supporting the internal audit program. Completing temperature control checks for products at goods receipt. Investigate FMD alerts received by the site. Any other quality duties which may arise. Key Skills & Experiences A third-level qualification in science is preferred but not essential. A minimum of 3 years of experience in a GxP environment is preferred, by not essential. Experience in the operation of warehouse management systems. Excellent PC skills, including Word & Excel, PowerPoint, etc. Experience in technical writing.