Quality Assurance Specialist – Full-Time, Onsite (Shift Role)Location:Onsite (Hybrid/Remote not applicable)Shift Pattern:4‑cycle rotating shift (12‑hour shifts)Shift Premium:33%Our Company is seeking aQuality Assurance Specialistto join our team in a sterile pharmaceutical manufacturing environment. This role is fully onsite and operates on a rotating 4‑shift cycle.Key ResponsibilitiesWork within a 4‑shift pattern, supporting sterile manufacturing operations.Carry out timely reviews of batch documentation (including EBRs), investigations, and reports.Highlight and help resolve issues based on risk level.Respond promptly to unplanned events and technical issues .Use quality systems such as SAP, Trackwise, and MES in a dynamic manufacturing environment.Maintain full knowledge of cGMP, GDP, and relevant US/EU regulatory requirements .Conduct weekly reporting of Quality Right First Time and audit readiness metrics .Support ongoing audit readiness and ensure compliance with cGMP standards.Participate in spot checks/walk‑throughs of production lines.Support customer complaint investigations when required.Work effectively cross‑functionally as an active team member.Position ResponsibilitiesProvide Quality support to IPT production teams and maintain high cGMP standards.Apply an understanding of sterile manufacturing operations (preferred).Use computerized systems to complete daily tasks effectively.Prioritize and manage multiple tasks while meeting deadlines.Liaise with other departments to drive improvements in GMP and Quality standards.Comply with Quality, EHS, and Manufacturing Division requirements relevant to commercial operations.Reporting StructureReports to: Quality ManagerQualifications & ExperienceEducationBachelor's Degree or higher in a Science discipline (preferred)Experience1–2 years experience in a Quality role within a pharmaceutical manufacturing facility (aseptic experience preferred).Experience with SAP, MES, and Trackwise is desirable.Skills & Technical KnowledgeStrong understanding of Irish, European, and International regulatory and code requirements.Essential knowledge of cGMP and GDP .Ability to write reports, standards, and policies.Competent use of MES and SAP .Prior experience working in a quality function or aseptic environment is highly beneficial.Shift Structure (4‑Cycle Rotation – 12 Hour Shifts)Week 1 – Long Week:Monday–Tuesday (Days)Friday, Saturday, Sunday (Nights)Week 2 – Short Week:Wednesday–Thursday (Days)Week 3 – Long Week:Monday–Tuesday (Nights)Friday, Saturday, Sunday (Days)Week 4 – Short Week:Wednesday–Thursday (Nights)Shift Premium:33%