QA Specialist

Purpose The Quality Assurance Specialist is a vital partner to our Integrated Production Team (IPT), ensuring the highest standards of quality and compliance are met in our sterile manufacturing facility. Your primary purpose is to safeguard product quality and patient safety by providing real-time quality oversight, reviewing critical processes, and fostering a culture of continuous improvement and cGMP excellence. You will be the on-the-ground quality expert, responding to events and ensuring our operations are always audit-ready. Shift Pattern : 4-shift pattern - 12 hours per shift Week 1- long week : Monday Tuesday Days then Fri, Sat, Sun nights Week 2- short week : Wed and Thurs Days, Week 3 : Long week : Monday Tuesday nights, Fri, Sat, and Sun days Week 4 : short week : Wedand Thurs nights Responsibilities Perform timely and detailed reviews of batch documentation, including Electronic Batch Records (EBRs), line clearances, and associated reports. Identify, highlight, and assist in the resolution of quality concerns, ensuring actions are commensurate with risk. Support the spot check and walk-through process of the production lines to verify adherence to cGMP. Respond quickly to unplanned events and technical issues, providing immediate quality guidance. Support and review investigations, including customer complaints, to ensure root causes are identified and effective CAPAs are implemented. Utilize quality systems (e.g., Trackwise, SAP, MES) for managing deviations, CAPAs, and change controls. Conduct, report, and display Quality Right-First-Time and audit readiness metrics weekly to drive continuous compliance. Liaise with department representatives to promote improvements in GMP and quality standards. : Provide daily Quality support to IPT production teams, acting as a subject matter expert on quality matters. Ensure compliance with our Company's Manufacturing Division, Quality, and EHS (Environment, Health, and Safety) Management System requirements. Requirements Bachelors Degree or higher in a Science discipline (Microbiology, Chemistry, Pharmacy, or related field) is preferred. Minimum of 1-2 years of experience in a Quality role within a pharmaceutical manufacturing facility; experience in aseptic / sterile manufacturing is highly preferred. Demonstrated operational experience with quality systems such as SAP, Trackwise, and MES (Manufacturing Execution System). Essential : Strong technical knowledge of sterile manufacturing processes and a full understanding of cGMP and GDP principles. Essential : Working knowledge of Irish, EU, and US regulatory requirements for sterile products. Proven ability to prioritize multiple tasks, manage deadlines, and work effectively in a dynamic, fast-paced environment. Strong problem-solving skills with the ability to make risk-based decisions. Excellent communication and report-writing skills. Competent in the use of Microsoft Office applications. Skills : Aseptic Manufacturing Experience SAP MES Trackwise Quality GMP