Quality Engineer Lead

4 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

As a Quality Engineer Lead at Eli Lilly and Company, you will play a critical role in ensuring the quality and integrity of our biopharmaceutical products.

This position offers the opportunity to lead a high-performing team and drive quality improvements across the organization.

About Us: We are a global healthcare leader, driven by our commitment to improving human health and transforming lives.

Key Responsibilities:

  1. Quality Assurance Oversight:
    • Lead the development and implementation of quality assurance strategies and programs.
    • Oversee Commissioning and Qualification (C&Q) activities, ensuring alignment with regulatory requirements.
    • Develop and maintain quality assurance policies, procedures, and systems.
    • Investigate and resolve deviations, non-conformities, and CAPA.
  2. Regulatory Compliance:
    • Monitor and stay up-to-date with changing regulations and guidelines.
    • Support regulatory inspections and audits, ensuring compliance with regulatory requirements.
    • Verify that all products meet regulatory standards.
  3. Documentation and Reporting:
    • Maintain accurate and comprehensive quality records, including procedures, qualifications, and quality reports.
    • Prepare and review documentation related to product quality and compliance.
  4. Quality Improvement Initiatives:
    • Promote continuous improvement by identifying areas for process enhancement and collaborating with cross-functional teams.
    • Participate in risk assessments and quality improvement projects.
  5. Training and Development:
    • Train staff on quality-related procedures and best practices.
    • Stay current with the latest developments in biotechnology and quality assurance.


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