Job Description
A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products. The role Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. Develop and maintain quality assurance procedures, policies, and systems Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports The Person BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements Experience with quality management systems (e.g., TrackWise, MES) is a plus For further details please contact;Paula OReillyon or send CV in confidence to Skills: QA Experience GMP Experience Quality Assurance