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.

• 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.