Senior Associate - Quality Assurance (MES)
Eli Lilly
- Limerick
- Permanent
- Full-time
- 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 associated with MES quality events.
- Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems.
- 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 MES.
- Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
- Develop common local procedures for MES and support review and approval of GMP documents associated with qualification and validation for MES.
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- Participate in risk assessments and quality improvement projects.
- Communication and education of personnel in GMP requirements and regulations related to MES
- Stay informed about the latest developments in eBRs and quality assurance.
- 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.
- 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 quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus.