Senior Manager

Job 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