Senior Associate

6 days ago

Limerick, Limerick, Ireland Eli Lilly and Company Full time
About Us

Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies.

Position Summary

This is an exciting opportunity for a highly motivated and detail-oriented QA Sr. Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our computer systems.

Key Responsibilities
  1. Quality Assurance Oversight:
    • 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.
  2. Regulatory Compliance:
    • 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 processes for systems.
  3. Documentation and Reporting:
    • 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.
  4. Quality Improvement Initiatives:
    • Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
    • Participate in risk assessments and quality improvement projects.
  5. Training and Development:
    • 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.

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