Regulatory Compliance Expert
5 days ago
Eli Lilly and Company is a leading global healthcare company committed to discovering and delivering innovative solutions that improve human health.
We are looking for an exceptional Regulatory Compliance Expert to join our quality assurance team and contribute to the success of our organization.
About Us: With a rich history of innovation and a dedication to improving human health, we have become a trusted partner to patients and healthcare professionals around the world.
Key Responsibilities:
- Quality Assurance Oversight:
- Oversee Commissioning and Qualification (C&Q) activities, ensuring alignment with regulatory requirements.
- Develop and maintain quality assurance policies, procedures, and systems.
- Lead self-inspections and monitoring assessments to ensure compliance with cGMP and other regulations.
- Investigate and resolve deviations, non-conformities, and CAPA.
- 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.
- 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.
- 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.
- 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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