Shrinivas Tripathi

Background

About Shrinivas Tripathi

Working as Asst.General Manager having 20 years of versatile experince in pharmaceutical industry in Analytical method development department having sound knowledge in Method development, Routine analysis, Stability studies, Analytical method validation and Technology Transfer for ROW markets including CIS countries, Africa, Philippines, Tanzania, Asian and Russia. 10 years of exclusive experience in EU markets and ANDA markets. Worked on different types of solid oral dosages method development for Hormonal products, ER and IR formulation injectables,Liposomal formulation,Suspesion and Syrup. Complete life cycle management of productsHaving sound knowledge of regulatory queries from various FDA team. Good knowledge of Root cause investigation and provide adequate scientific support to site to resolve OOS and OOT closure. Provide technical support required in analytical method to site to release the commercial batches as if when required. Planning and execution of routine Analytical support for formulation development through reverse engineering and discriminating media development for formulation optimization. Planning and execution of analytical method Validation and Technolgy transfer at GMP site as per scheduled date.Taking care of on line release of pre scale up and scale up batches, market compliance, Alternate vendor development study and selection of vendor. Plan the analysis and provide data for Pilot BE and Pivotal BE related study.Maintained the GLP and keep the department updated in audit readiness, fullfil deprtamental requirement for smooth functioning, provide training to subordinate and discussing and meeting with all functional heads to achieve and complete the organizational goal with zero error policy.