Pradip Kumar Das

Background

About Pradip Kumar Das

Monitoring Scientist for preclinical toxicology in animals and give presentation to NDAC (NEW DRUGS ADVISORY COMMITTEE (NDAC) for Clinical trials Presentation to RCGM, Department of Biotechnology, New Delhi (Review Committee on Genetic Manipulation) on new recombinant to be tested for Preclinical studies Review annual product ensures that all new/reformulated, as well as existing products in manufactured at BE Sites. Investigate the market complaints received by the customers and reply with investigation with root cause. Provides support during new product development and reformulations. Use of trackwise® operations for compliance like change control, deviations, out of specification, out of trends (Quality management systems). Monitor quality of releases of vaccines and compliance of data and ensure timely tracking and publishing of results. Perform safety and efficacy (potency assays in-vivo like diphtheria, pertussis, tetanus, Hepatitis B, Hib, Rabies studies related to pediatric Vaccines Vendor audit Preparation and review of Non-clinical sections for regulatory submissions. Reviews and approves study protocols, performs pre and post approval of test scripts, and review and approval of change controls deviations. Conducting analytical method validation as per regulatory guidelines Trends Analysis and proof check data for vaccines. Prepare monthly report and give presentation progress report for above mentioned vaccines. Conduct non clinical trial studies of vaccines in rodent and non rodent species as per WHO and FDA guidelines. Working under GLP norms Involve as a internal auditor in various departments