Yogesh Naik
Head of Quality Control
- Role
- Associate Director Quality Control at Rising Pharmaceuticals
- Location
- Decatur, IL, US
- LinkedIn followers
- 500 followers
About Yogesh Naik
Good knowledge of set up new Quality Control Laboratory in India and overseas…
Experience
Associate Director Quality Control
Oct 2023 — Present
Established a state-of-the-art QC lab for injectable products, ensuring regulatory compliance and equipment qualification.Authored 100+ SOPs covering OOS/OOT, stability, validation, and analyst training.Designed onboarding programs and recruited 15+ QC professionals to boost lab capacity.Led documentation support team and validated analytical/cleaning methods for Orphenadrine Citrate USP Injection.Directed IQ/OQ/PQ for HPLC, UV-Vis, TOC; validated 21 CFR Part 11 software systems.Spearheaded glassware cleaning validation and DEA-compliant controlled substance handling.Delivered targeted training in cGMP, 21 CFR 211.194, and analytical techniques.Achieved $400K+ in cost savings via process optimization and vendor negotiations.Consistently enhanced productivity while maintaining top-tier quality standards.
Education
University of Mumbai
MSIT
2003 — 2005
University of Mumbai
Master of Science - MS
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