Prashant Pawar

Background

About Prashant Pawar

Over twenty years of Extensive Experience in the Life Sciences, Pharmaceutical and Healthcare sector, encompassing Biotechnology, Injectable, Sterile, API and OSD manufacturing plants. Expertise in Automation System, CSA and CSV with Life Cycle management for Manufacturing, Laboratory, IT and Enterprises system with Plant Automation, Instrumentation, Testing and Qualification. Process Expertise in Design and Development of Automation system with DCS, SCADA, PLC, HMI, VFD’s, Field Instrumentation, and expertise for various Enterprise applications like LIMS, CDS, eDMS, LMS, Track wise, Master Control (QMS, DMS, LMS), SAP. Project Management, Implementation, Operation, Remediation, upgradation, integration and retirement for GxP and Non GxP systems, System evaluation and implementation for GxP Gap Assessment with Short Term and Long Term action plan for manufacturing and laboratory system. High expertise in Designing, Executing Projects and Maintaining various Automation System with High Quality and Safety Norms with SDLC, GAMP5, 21CFR PART11, EU Annex 11, ERES, GXP, ICHQ9, cGMP, GDP. Delivery lead for CSV project for Manufacturing, Laboratory, IT and Enterprises systems as per SDLC and GAMP 5 approach like System Impact Assessment, 21 CFR Assessment, Risk Assessment, Project Validation Plan, User Requirement Specification, Functional Requirement Specification, Configuration Specification, Design Specification, FAT, SAT, IQ, OQ, PQ, RTM, Validation Summary Report, Post Implemented Review. Proficient in managing Access Controls, User Management, Electronic Data Management, Audit trail management, review, Backup and Restoration, Periodic review of backup data and Disaster Management. Strong knowledge of QMS like Events, Deviations, Investigations, CAPA, Change Controls etc, SOP Preparation, Review, Translate technical information and requirements into qualification/validation test design. Work for regulations of US FDA, EU EMA-EudraLex, UK MHRA. Excellent interpersonal, team building and leadership skills with proven key account development, delivery and relationship management abilities.