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QA for QC – Dry External Manufacturing at Eli Lilly and Company - ApplyBlast

QA for QC – Dry External Manufacturing

Eli Lilly and Company

4 months ago

4.0 on Glassdoor

Hyderabad, India

Onsite

Full Time

Senior

0 applicants

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About this role

The Dry Product External Manufacturing QA Representative at Lilly provides quality assurance oversight of Contract Manufacturing Organizations' laboratory operations, ensuring compliance with cGMP and regulatory standards for solid oral dosage forms. This role serves as the primary liaison between external manufacturers and Lilly, managing quality issues, coordinating sample shipments, and supporting regulatory inspections while maintaining data integrity across laboratory systems.

Responsibilities

Provide quality assurance oversight of Contract Manufacturing Organizations laboratory operations
Serve as liaison between CMs and Lilly for all laboratory related quality issues
Conduct routine reviews of laboratory practices through data integrity assessments and audit trail reviews
Oversee CM laboratory investigations including Out of Specification deviations and CAPA management
Participate in regulatory inspection preparations and provide on-site support during inspections

Skills

Qualifications

BS in Pharmacy, Chemistry, Biological Sciences, or related Life Sciences8 years of GMP experience in pharmaceutical laboratory quality assurance or quality control

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.