Quality Operations Specialist

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My client, a start-up Biologics company in Waterford are in the process of building their Quality Department and are looking for a Quality Operations Specialist to join their team. As Quality Operations Specialist, you will be responsible for supporting the maintenance and management the Pharmaceutical Quality System so that it is consistently deployed and maintained for operations and supporting functions. You will initiate action to correct quality and or compliance concerns, inform as appropriate through the Quality Leadership Team. As Quality Operations Specialist you will;Ensure review of all Quality and production batch documentation is completed correctly, to achieve a high level of customer service and cGMPEnsure customer / contract services Technical Agreements are implemented and maintained according to established proceduresProvide support for the development, implementation and maintenance of the HTID Pharmaceutical Quality System and supplier management programProvide support for management of complaints, deviations, CAPA's and change controls associated with commercial productsSupport Investigating out-of-trend/specification (OOT/S) reportsProvide operation and maintenance support of quality documentation systemEnsure that Batch documentation, Laboratory results and related Quality System documentation is correct and approved prior to QA/QP release Education & Experience:Bachelor's degree in chemistry, biology or a related discipline is desirable.5 years' experience working in Quality or Manufacturing, with a minimum of 2 years in a sterile manufacturing environment.Experience with investigations, change controls and CAPAs. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales