Quality Assurance Specialist – Fixed Term Contract (11 Months, On-Site in Carlow)Pay rate e/hr plus 33% shift PremiumRole OverviewThe Quality Assurance Specialist will play a crucial role in ensuring compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements in a dynamic pharmaceutical manufacturing environment. The role requires providing QA support to production teams, conducting batch documentation reviews, and supporting audit readiness, with a focus on sterile manufacturing processes.Key ResponsibilitiesWork within a 4-shift pattern role, supporting manufacturing operations on-site.Provide QA support to production teams, ensuring adherence to cGMP and quality standards.Conduct timely reviews of batch documentation (EBRs), line clearances, investigations, and reports, resolving concerns based on risk assessment.Support audits, inspections, and spot checks/walk-throughs of production areas to maintain audit readiness and compliance.Respond quickly to unplanned events and technical issues in manufacturing.Ensure continuous improvement of quality systems, tracking metrics such as right-first-time documentation and compliance KPIs.Engage in customer complaint investigations, deviations, and CAPA processes as required.Utilize quality systems (SAP, TrackWise, MES) to manage and document QA activities.Maintain a strong understanding of cGMP, GDP, US and EU regulatory requirements .Promote a culture of compliance, safety, and audit readiness across the site.Qualifications & ExperienceBachelor's degree (Science discipline preferred) .2-3 years' experience in a quality role within a pharmaceutical manufacturing facility, preferably aseptic/sterile operations.Demonstrated knowledge of cGMP, GDP, US and EU regulatory requirements .Experience with SAP, MES, TrackWise (or equivalent QA/ERP/QMS systems) is desirable.Strong skills in report writing, standards interpretation, and technical documentation .Ability to prioritize multiple tasks, manage time effectively, and meet strict deadlines .Flexible to work shift-based schedules .Specialized SkillsBatch Record Review (EBR/BMR), Line ClearanceDeviations, CAPA & Change Control (TrackWise, SAP, MES, EDMS)cGMP, GDP, Data Integrity (ALCOA+)Audit Readiness & Regulatory Compliance (FDA, EMA, EU GMP Annex 1)Sterile / Aseptic Manufacturing QA Support