Orion Group Life Sciences are currently recruiting aQuality Assurance Specialist (Shift)on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-Month contract.This is a shift position– 4 cycle 12 hours per shiftWeek 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: Wednesday and Thurs NightsShift premium is 33%Role OverviewThe Quality Assurance Specialist is required to:Work a 4-shift pattern rolePossess technical knowledge of sterile manufacturing processesPerform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns commensurate with riskRespond quickly to unplanned events and technical issuesDemonstrate operational experience with quality systems in a dynamic manufacturing environment (e.g. SAP, Trackwise, MES)Have a full understanding of relevant quality and compliance regulations, including knowledge of requirements for cGMP and both US and EU regulatory standardsConduct, report, and display Quality Right First Time and audit readiness metrics weekly to ensure continuous audit readiness and cGMP complianceSupport the spot check and walk-through processes of production linesParticipate in customer complaint investigations as requiredAdditional ResponsibilitiesProvide Quality support to production teams to ensure cGMP standards are consistently maintainedUnderstand sterile manufacturing operations (preferred)Learn and utilize computerized systems to perform daily tasksPrioritize and manage multiple tasks to meet defined deadlinesReview batch documentation (e.g. Electronic Batch Records), perform line clearances, and assist in resolving concernsLiaise with other departments to promote improvements in GMP and Quality standardsComply with all relevant Quality and EHS Management System requirements as applicable to commercial operationsQualifications & ExperienceEducationBachelor's Degree or higher preferred in a Science disciplineExperience1–2 years' experience in a Quality role within a pharmaceutical manufacturing environment, preferably sterile/aseptic manufacturingExperience using systems such as SAP, MES, and Trackwise (desirable)Strong technical writing and documentation skillsWorking knowledge of applicable Irish, European, and international codes, standards, and practicesSolid understanding of cGMP and GDP requirementsCompetency in the use of MES and SAP systems