Regulatory Compliance Expert

5 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time
Key Responsibilities:
  • Quality Assurance Oversight:
    • Influence and oversee Commissioning and Qualification (C&Q) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
    • Develop and maintain quality assurance procedures, policies, and systems.
    • Conduct routine self-inspections and monitoring assessments 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).
  • Regulatory Compliance:
    • Stay current with industry regulations, guidelines, and best practices.
    • Assist in the preparation and execution of regulatory inspections and audits.
    • Ensure that all products meet regulatory requirements, including documentation and reporting.
  • Documentation and Reporting:
    • Maintain accurate and comprehensive quality records, including procedures, qualification documentation change control documentation, and quality reports.
    • Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.
  • 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 quality-related procedures and best practices.
    • Stay informed about the latest developments in biotechnology and quality assurance.


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