Regulatory Compliance Specialist
5 days ago
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them.
We are a cutting-edge biotechnology company dedicated to revolutionizing the healthcare 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.
Position SummaryThe Qualified Person plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. This position is responsible for implementing and executing batch approval and regulatory authorization for the site.
Key Responsibilities- Technical Leadership: Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
- Quality Monitoring Programs: Monitor the Site Self-Inspection program and audit of production, systems, and service areas for compliance with Product Quality Systems, policies, guidelines, and procedures.
- Document Review/Approval: Responsible for reviewing and approving change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies, and reports associated with the manufactured batches.
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