A Stability QA Sr. Associate is required a leading global Biopharmaceutical organisation in Limerick. This is an opportunity to play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within this next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. The Role Develop and maintain quality assurance procedures, policies, and systems. Oversee the stability & reference standards program and ensure compliance with global, regulatory and quality standards (e.g., ICH Q1A-Q1E, FDA, EMA, WHO) including Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Support actively stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met. Act as a subject matter expert (SME) in stability & reference standard quality assurance and support audits and regulatory inspections. Ensure proper storage, sampling, and testing of stability & reference standard samples, under defined conditions (e.g., accelerated, long-term, and stress studies). Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership. Support investigations and corrective/preventive actions (CAPAs) related to stability issues. The Person: BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline. Minimum of 3 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment. Strong knowledge of ICH guidelines (Q1A-Q1E), FDA/EMA regulations, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements. Proficiency in data analysis and statistical tools for stability trend evaluation (e.g., JMP, Minitab). Excellent problem-solving and analytical skills. For further details please contact;Paula OReillyon or send CV in confidence to