JOB DESCRIPTION & SPECIFIC OBJECTIVESThe Quality Assurance Specialist within Our Company is required toWork a 4 shift pattern roleTechnical 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 memberPOSITION RESPONSIBILITIESProvide 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.REPORTING STRUCTUREReports to Quality ManagerQUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTSSkills and KnowledgeTypical Minimum Education· Bachelor's Degree or higher preferred in a Science disciplineTypical Minimum Experience· 1-2 years experience in a Quality Role at pharmaceutical manufacturingfacility preferably aseptic manufacturing· Experience in SAP, MES, Trackwise desirable· TechnicalWorking knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices· Knowledge of cGMP and GDP essential Report, standards, policy writing skills required· Competent in the use of MES and SAPThe position is onsite and remote or hybrid is not applicable for this role,This is a shift position – 4 cycle 12 hours per shift e.gWeek 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nightsWeek 2- short week: Wed and Thurs Days,Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun DaysWeek 4: short week: Wednes and Thurs NightsShift premium is 33%For the job shift experience, working in a quality function or in an aseptic environment is beneficial