Senior Quality Assurance Specialist
2 days ago
At Eli Lilly and Company, we combine our passion for innovation with a commitment to excellence in quality assurance.
We're seeking a highly motivated and detail-oriented Senior Quality Assurance Specialist to join our quality assurance team supporting our facilities, cleaning, and utilities. This role will play a critical part in maintaining the highest standards of product quality and compliance.
About Us: As a global healthcare leader, we're dedicated to revolutionizing the 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.
Key Responsibilities:
- Quality Assurance Oversight:
- Influence and oversee Commissioning and Qualification (C&Q) of GMP assets, including review and approval of associated deliverables.
- 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.
- Investigate and address deviations, non-conformities, and CAPA.
- 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.
- Quality Improvement Initiatives:
- Identify areas for process improvement and work collaboratively with cross-functional 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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