Vinod K Sharma

Background

About Vinod K Sharma

A dynamic professional with more than 16 years of comprehensive experience in complex Manufacturing formulation, Packaging, Documentation & Manpower Management in Parenteral. Presently working in Amneal Pharmaceutical as Sr. Manager-production from May 2016 to till date. Key Responsibilities in operations- Responsible for overall activity of production departments. Responsible for Audit and compliance. Experience of pharmaceutical regulatory audits like USFDA, MHRA etc. Handling 3 Filling line in SEZ plant of Amneal pharmaceutical: a) Vial line (Aseptic+ TS product + Lyo product): 2 mL to 30 mL container size. b) PFS Line 1mL to 10mL container size. c) Cartridge Line 1mL to 3mL container size. Handling 2 filling lines in Pipan plant of Amneal Pharmaceutical. d) Vial line with Isolator and Lyophilizer– Under qualification stage. e) Robotic Vial Line with isolator- Under qualification stage. Managing overall operations and ensure timely accomplishment of production targets within the cost parameters. Managing a team of more than 98 employees including Manager, Dy Manager, executives, officer, operators, and workers. Overseeing entire Procurement activities, implementing effective techniques to bring efficiency in operations, improve quality standards & achieve maximum cost savings. Planning, effective manpower deployment & works scheduling of qualified workforce; addressing training needs of staff to enhance skills and productivity. Taking care of submission batches as per schedule. Coordinate with product development team and RA for new exhibit batches. Ensure the maintenance of the facility and equipments on timely basis. Responsible for Project work in plant (Commissioning, installation, and qualification of equipments and area). Preparation of Daily and monthly reports. Maintaining (material, process, personnel, scrap, documentation) flow, safety, and cGMP, within the department. Identify the cost reduction parameters and implementation. Identify and eliminate hazards in the production operations. Identify the cost reduction parameters and implementation. Identify and eliminate hazards in the production operations. Identify training & development needs for subordinates & employees. Ensure the documents should be as per quality systems and comply with regulatory standards. Review and implementation of SOPs and work done as per approved standard procedures. Handling of Deviation, Change control, CAPA, Risk assessment, Impact assessment.