Principal Associate - Computer Systems Quality Assurance
- Limerick
- Permanent
- Full-time
- Implement Global Quality Standards to the new Lilly Limerick site.
- Provide quality direction and governance for QA-owned e-systems, site IT systems, and site laboratory systems.
- 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 quality.
- Review and approve change controls related to GxP systems and lab equipment, ensuring appropriate impact and risk assessments.
- Apply ICH Q9 principles to qualify and mitigate risks in system-related changes or deviations Participate in IT and quality organizations to provide consistency across all computer systems areas.
- Evaluate events related to data loss, system outages, or unauthorized access from a quality and compliance perspective.
- Perform and support data flow mapping for production, analytical, and site-wide processes.
- Partner with Digital/IT, QC, TSMS and Engineering teams to ensure GxP compliance of all laboratory e-systems and analytical technologies.
- Ensure compliance with CSV and data integrity principles, including ALCOA+ and 21 CFR Part 11.
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
- Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for IT systems.
- Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP IT systems.
- Conduct or oversee data integrity assessments across systems and equipment and contribute to audit readiness for QA owned systems, QC systems and Process analytical technology systems.
- Assess compliance with 21 CFR Part 11 / EU Annex 11 for electronic records, electronic signatures, audit trails, user access, and backup/restore functions.
- Review audit trail reviews, non-terminal record reviews, exception reports, and integrity control mechanisms.
- Ensure GxP computerized systems undergo routine periodic reviews to assess validation status, user access, audit trail review, and backup testing.
- Ensure readiness of computerized systems and equipment documentation and provide defense of QA oversight activities.
- Support CSV (Computerized System Validation) strategy and execution for GxP systems, ensuring fitness for intended use and regulatory compliance
- Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
- Develop common local procedures for computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
- Develop or contribute to GxP procedures, templates, and guidance documents related to CSV, equipment qualification, data integrity, and system governance.
- Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- Participate in risk assessments and quality improvement projects.
- Drive risk-based decision-making and QA input into digital and automation initiatives.
- Identify and implement QA best practices in support of a fully digital lab environment.
- Provide independent QA oversight throughout the computerized system lifecycle: from planning, specification, qualification/validation, operation, to retirement/decommissioning
- Provide training to staff on all relevant aspects of computer system quality.
- Stay informed about the latest developments in computer systems validation and quality assurance.
- Deliver training on CSV principles, data integrity, and regulatory expectations to internal teams.
- Promote a culture of compliance and continuous improvement related to computerized systems and lab automation.
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- Minimum of 5 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.
- Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
- Experience with data flow mapping and within electronic quality management systems (e.g., TrackWise) and other pharmaceutical IT systems.
- Experience in computerized system validation of QC equipment and process analytical technology.
- Self-driven and comfortable working independently in a dynamic, startup-like environment.