Lupin—Senior Manager

Job description

Description: Job Description - Responsible for Overall Mechanical Maintenance of production equipment ,utility equipment, Purified water system and HVAC operations. - Monitoring of Breakdown of all production equipment , utility equipment’s , , Purified water system and HVAC for Mech & Elec - Monitoring of Capex from selection of equipment, Installation, commissioning & Qualification. - Audit trail review of all computer based systems - Knowledge of Calibration of analytical & Digital instruments,SAP,SABA,Veeva - In-depth knowledge for 21 CFR compliance, PLC Validation , computer system validation . - Knowledge of statutory compliance of cGMP , GxP , Regulatory requirement of EH & S - Familiar with regulatory inspections like USFDA, MHRA, WHO, etc. Work Experience 12-15 years Education Graduation in Engineering or Mechanical Engineering Competencies