Senior Quality Assurance Specialist
1 week ago
About Eli Lilly and Company
Eli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. Our mission is to unite caring with discovery, improving human health through innovative medicines and solutions.
Job Summary
We are seeking a highly motivated and detail-oriented Senior Associate to join our quality assurance team at our next-generation manufacturing facility in Limerick, Ireland. As a Manufacturing Execution System (MES) Quality Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities:
- 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.
- Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA to maintain quality associated with MES quality events.
- Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems.
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
Qualifications:
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
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