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QA Representative - API EM at Eli Lilly and Company - ApplyBlast

QA Representative - API EM

Eli Lilly and Company

3 months ago

4.0 on Glassdoor

Hyderabad, India

Hybrid

Full Time

Senior

0 applicants

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About this role

A Principal Associate in Quality Assurance at Eli Lilly supports external manufacturing organizations by ensuring API batches meet specifications and comply with cGMPs and regulatory commitments. The role involves liaising with contract manufacturers, overseeing quality plans, participating in regulatory inspections, and managing batch documentation and release processes. Candidates must have extensive experience in big pharma QA and a strong background in GMP manufacturing environments.

Responsibilities

Provide quality oversight of external contract manufacturers and API shipments
Serve as the initial point of contact for quality-related issues at manufacturing sites
Participate in regulatory inspection preparations and joint process teams
Review and approve critical documents including procedures and change control proposals
Evaluate and disposition API batches to ensure compliance with specifications

Skills

Qualifications

BS in Pharmacy, Chemistry, Biological Sciences, or Life SciencesMaster of Science preferred

About Eli Lilly and Company

lilly.com

Headquarters

Indianapolis, Indiana, United States

Company Size

10001+ employees

Founded

1876

View Profile

Eli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.