Yogesh Naik
Associate Director Quality Control @Rising Pharmaceuticals
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WORK HISTORY
Associate Director Quality Control @Rising Pharmaceuticals
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
University of Mumbai
Master of Science - MS
ABOUT YOGESH NAIK
Good knowledge of set up new Quality Control Laboratory in India and overseas…
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