Sunil Kumar
Pharmaceutical Quality Leader | Site QC Head | 20+ Yrs in QC/QA | GMP Compliance | Regulatory Audit Readiness (WHO, TGA, SAHPRA, ANVISA) | Continuous Improvement/Operation Excellence | Driving Global Quality Excellence
- Role
- Deputy General Manager at Aristo Pharmaceuticals Pvt. Ltd.
- Location
- Hamirpur, HP, IN
- LinkedIn followers
- 500 followers
About Sunil Kumar
I am an accomplished quality professional with over two decade of industry experience…
Experience
Deputy General Manager
Aristo Pharmaceuticals Pvt. Ltd.
Sep 2023 — Present · Daman and Diu, IN
Leading a 55-member QC team including microbiology lab for OSD formulations (tablets, capsules, liquids, suspensions) for India & ROW markets.• Ensuring regulatory compliance with CDSCO, WHO, and ROW audits by implementing Global Quality Standards.• Spearheaded LEAP (Laboratory Excellence Achievement Program), achieving 20% productivity improvement through lean practices.• Directed technology transfer, RM/PM/FP release, stability studies, OOS/OOT investigations, deviation, CAPA, market complaint and change control.• Implemented continuous improvement projects like kaizen, 5S, PDCA, Six Sigma to optimize the QC operations.• Ensuring laboratory safety and management of hazardous & bio medical waste.• Achieved 99.95% accuracy in QC operations with 100% productivity goal attainment.
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