Compliance Specialist

Title: Compliance EngineerThis position is based at our clients’ site in the County Waterford area, the purpose of this position is to ensure all department compliance metrics are up to date and the department is always in an audit ready state regarding quality / EHS systems.As a Compliance Engineer, you will be responsible for:Track and monitor all department compliance metrics (EHS / Quality)Interact with the responsible persons regarding completing action’s related to metrics closure (Carisma, CAPA, DE, MC etc) Be the department Quality System MERP’s SMEEnsuring all monthly forums take place and minuted (EHS / Quality)Coordinate monthly Level 1 audits / annual level 2 audits / coordinate interim L3 & L4 audits for departmentCoordinate monthly GEMBA;s with Quality / EHS / Dept SMECoordinate Depatment Risk Map and track Risk Assessments to scheduleTrack RMS acions to closureReview EHS and Quality alerts with dept SME team and carry out gap analysisEnsure all AVL’s are in place, in use and up to dateComplete any department related DE’s raised with department SME’sComplete any department related IN’s with support from the department SME.Support organising training courses coming dueCoordinate all due Dept Documentation with dept admin and approvalsManage completion of EHS related metricsArrange monthly EHS inspectionsArrange and chair monthly EHS meetingsPrepare the department risk map and coordinate the risk assessment scheduleRead and understand Standard Operation Procedures applicable to roleFeed into Tool Box Talks relating to complianceEnsure that any training SOP’s are read and CAQ’s signed off on promptly Ensure all Safety Permits are filled out as required for each job being carried outThe maintenance department is audit ready What we need from you is:Third level Qualification in Engineering or equivalent or preferred Level 7 Qualification in EngineeringWorked previously in a pharmaceutical/Medical Devices manufacturing environment. Worked as an Engineering compliance engineerRequired knowledge to be effective in the role Experience:·       5 years in a similar role as the role requires reasonable experience to carry out all tasks as per the role responsibility Skills/Background:·       Green Belt. ·       Working knowledge of DMAIC or similar process that drive problem resolution and improvement




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