Sr. Associate - Quality for Computer Systems ValidationA Computer Systems Quality Sr. Associate 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 our biopharmaceutical products. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities: 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.Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.Participate in IT and process automation organizations to provide consistency across all computer systems areas.Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.Develop common local procedures for Computer systems and help the site consistently interpret and implement global policies across all computer systems areas. The Person: BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.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.Detail-oriented with a strong commitment to maintaining high-quality standards.Effective communication and teamwork skills.Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus. For further details please contact Paula O'Reilly on 087 7094141 or send CV in confidence to ******.
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