Nishith Pathak

Background

About Nishith Pathak

ABILITIES: 1. Designing, installation and commissioning of API Manufacturing Plant. To acquire all necessary government licenses to manufacture API. To design & establish DSIR approved R&D centre for development of API. To review and approve TTD (Technology Transfer Document) for Biotech & Synthetic API, and ensure the Technology at PILOT PLANT. The successful transfer of Technology to commercial scale up batches and assimilates the process and other aspects thoroughly while implementation of new products / technologies at the plant for optimum output and quality standards. Strong hold on designing and implementation of Quality Systems and Regulatory compliances (i.e. To review Qualifications for Water System, HVAC, Production & utility equipments, Manufacturing and Testing Process Validations, Annual Product Quality Review ( APQR ).To review technology transfer documents, Product Development Report, Drug Master Formula (DMF), to review specifications of Raw Materials, Packing Materials, water and Finished Goods, to review Standard Operation Procedures ( SOPs), to review Cleaning Validation and Equipment Qualification Protocol and planning, to handle deviations, change controls and their evaluations, to handle Out of Specifications and their investigations, to handle market complains and recalls, to review for internal self audit, to conduct training on GMP and Quality System. Working as an auditor in international prestigious inspections like WHO, EDQM, USFDA, and OHSAS 18001 (inspection of Health and Safety). FDA Approved by Govt. of Maharashtra and Gujarat in Bulk drug Production, Approval no: TP/GTB/3II/1098/46468/B and JC/KD/QP-172/157-09/3. Highly exposed to the high-tech computerized process operating systems like DCS, SCADA, and PLC. Over all techno-commercial experience in Pharmaceutical Industries in various functions like Marketing, Planning and implementations of manufacturing operations ( Biotech & Synthetic) in API and its formulations, Designing Quality Systems for water, air and finished goods and their implementation, Designing cost awareness programs and evaluations of their implementations, Designing HR policies for competent personnel and their regular training, Liaison with government authorities like FDA, Pollution Control Board, Industrial Corporation, Central & State Excise, Factory Inspectorate, etc.