A Senior Associate Quality for Computer Systemsis required to join a global cutting-edge biotechnology company in Limerick. You will 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.
• Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
• Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
• Investigate and address deviations, non-conformities, and CAPA to maintain quality.
• Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
• Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.

• BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
• Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
• Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
• Excellent problem-solving and analytical skills.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus