Quality Systems Specialist

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My client, a global pharmaceutical company with a significant presence in Cork, are looking for a Quality Systems Specialist to join their growing team.This is a role which would see you working on global system improvement projects, and being a system owner with regard to the QMS.As Quality Systems Specialist, you will report into the Quality Systems Manager and will assist in ensuring that the QMS, the associated Electronic QMS software (EQMS), Master Control and other validated electronic systems are operated and maintained in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations.Main Responsibilities:System owner of EQMS, (onsite and additional business units), responsible for the development, integration, modification, operation, maintenance, and upgrading of system. Maintaining compliance in accordance with cGMPs, GAMP, Annex 11, 21 CFR Part 11 and other applicable regulations. Quality reviewer/approver for quality processes e.g. change controls, deviations, CAPAs, Standard operating procedure (SOP) and other quality related documents. Co-ordinate Change Control requests and associated documentation from CMO sitesProvide quality support to other departments in relation to validated electronic systemsParticipate in internal audit programCo-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and preparation for and/or conducting internal auditsDevelopment and/or appraisal of systems for tracking, trending and reporting of Quality/Site Metrics/KPI'sEducation & Experience:6+ years pharmaceutical experience in a progressive multinational organisation. Minimum 4 years in a Quality Assurance role.Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.Prior experience of being a system owner of an EQMS 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