PE Global is currently recruiting QA Specialist on behalf of our client based in Carlow:11-month initial contract- with 33% Shift Premium – 4 cycle shift pattern, 12 hours day/nightsJOB DESCRIPTION & SPECIFIC OBJECTIVESThe Quality Assurance Specialist within Our Company is required to:Work 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 requiredProvide 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.QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTSTypical Minimum EducationBachelor's Degree or higher preferred in a Science disciplineTypical Minimum Experience1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturingExperience in SAP, MES, Trackwise desirableTechnicalWorking 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 SAPInterested candidates should submit an updated CV.Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***