ResponsibilitiesTechnical knowledge of sterile manufacturing processesPerform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the riskRespond quickly to unplanned events, technical issuesOperational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MESFull understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirementsConduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP complianceSupport the spot check/walk-through process of the production linesInvolved in customer complaint investigation if requiredWork well cross functionally and be an active team memberProvide Quality support to IPT production teams to ensure cGMP standards are maintained.Understanding of sterile manufacturing operations is preferred.Ability to learn and utilize computerized systems for daily performance of tasks.Ability to prioritize, manage multiple tasks, and meet deadlines.Perform timely reviews on batch documentation ( EBR's ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standardsComply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.RequirementsBachelor's Degree or higher preferred in a Science discipline1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturingExperience in SAP, MES, Trackwise desirableWorking knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and PracticesKnowledge of cGMP and GDP essential Report, standards, policy writing skills requiredCompetent in the use of MES and SAPThe position is onsiteThis is a shift position - 4 cycle 12 hours per shiftWeek 1- Monday and Tuesday Days, Friday, Saturday, Sunday nightsWeek 2- Wednesday and Thurs Days,Week 3:: Monday and Tuesday nights, Friday, Saturday and Sunday daysWeek 4: Wednesday and Thursday nights