Joshi Dhiren Kumar

Background

About Joshi Dhiren Kumar

Experience in Pharmaceutical formulation Industry, Achievement in start to end quality production management with validation and documentation in the regulatory plant like Mylan, Dr. Reddys lab, Wockhardt ltd, Cadila pharmaceutical, J.B chemical & pharmaceutical, sovereign pharma pvt ltd.@ Having experience in Green field and brown field sterile formulation projects.@Having experience in sterile formulation production.@ Working experience in Ampoule, Vial,PFS,Cartridges, Opthalmic three piece facilities, BFS, FFS & lyophilization.@Exposure of handling equipment IQ, OQ,PQ.@knowledge about calibration & validation of equipments & machines.@Equipment exposure like Autoclave, Tunnel, Vessels, lyophilizer, filter intgrity testing machine, Isolators, Auto CIP/SIP machine, DHS, leak test appratus, High pressure homogenizer, Filling & Washing machines etc.@Experts in Media filling & process validation.clening validation and Technology Transfer of the product.@ change control, deviation, CAPA, risk assessment.audit & compliance.@ Having working exposure in USFDA, MHRA, MCC, WHO (Geneva) and ANVISA approved plant.Involved in Local FDA Audit and giving the cGMP training on motivation of workman with good planning successfully faced internal & external audit.