Biopharmaceutical Quality Assurance Specialist
3 days ago
Eli Lilly and Company is a global healthcare leader seeking a highly motivated and detail-oriented QA Sr. Associate to join our quality assurance team. As a Senior Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility.
Key Responsibilities- Quality Assurance Oversight:
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
- Regulatory Compliance:
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
- Ensure compliance with periodic review, change control, deviation, back-up, and archive processes for systems.
- Documentation and Reporting:
- Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
- Develop common local procedures for Computer Systems and help the site consistently interpret and implement global policies across all Computer Systems areas.
- 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 all relevant aspects of Computer System quality.
- Stay informed about the latest developments in Computer Systems validation and quality assurance.
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Limerick, Limerick, Ireland Eli Lilly and Company Full timeCompany OverviewEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, with operations in over 80 countries worldwide. Our employees are united by a shared passion for improving human health through innovative medicines and solutions.Job TitleSenior Associate - Quality Assurance for Manufacturing Execution...
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Limerick, Limerick, Ireland Eli Lilly and Company Full timeCompany OverviewEli Lilly and Company is a global healthcare leader dedicated to revolutionizing the biopharmaceutical industry. Our state-of-the-art manufacturing facility in Limerick, Ireland, employs cutting-edge bioprocessing technologies to create life-saving therapies.Job DescriptionWe are seeking a highly motivated and detail-oriented Manufacturing...
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