Biotechnology Quality Assurance Associate

5 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

About the Role


Eli Lilly and Company is a world-leading biotechnology company that is changing the face of healthcare by bringing innovative treatments to those who need them most. We're looking for a skilled QA Automation Professional to join our team and play a vital role in ensuring the quality and compliance of our biopharmaceutical products.



Job Summary


The successful candidate will be responsible for implementing and upholding quality assurance standards, facilitating inspections and audits, and supporting continuous improvement initiatives. This includes developing and maintaining quality assurance procedures, conducting routine self-inspections, and collaborating with automation, IT, and production teams.



Responsibilities:



  • Quality Assurance Oversight

    • 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.
    • Participate in IT and process automation organizations to provide consistency across all computer systems areas.

  • 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, backup, and archive processes for systems.

  • 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.

  • 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.

  • 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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