Himaja V.
Clinical Trial Labeling Regulatory Compliance Associate @Eli Lilly and Company
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WORK HISTORY
Clinical Trial Labeling Regulatory Compliance Associate @Eli Lilly and Company
Indianapolis, IN, US
Collaborated with Global Regulatory Affairs, QC, and Clinical teams to manage ATLAS phrase libraries, support product labeling, and ensure standardized scientific messaging across submissions.• Executed and tracked regulatory requests (ZZ orders, Load & Go orders) while managing document version control, change controls, and deviation tracking in TrackWise, QDocs, SAP, and Veeva Vault.• Supported aseptic sample handling, sterility testing, microbial enumeration, and environmental monitoring, maintaining compliance with cGMP standards and ALCOA+ principles.• Drafted, reviewed, and updated SOPs, technical reports, and validation protocols, contributing to regulatory readiness, batch record accuracy, and operational efficiency.• Partnered with cross-functional teams to investigate deviations, implement CAPAs, and optimize laboratory processes, driving continuous improvement and inspection readiness.
ABOUT HIMAJA V.
I\'m a clinical research professional with 3+ years of experience executing FDA-regulated,…
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