Job Description1 Responsible for Overall Mechanical Maintenance of production equipments & utility equipments.2 Indepth knowledge for 21 CFR compliance, PLC Validation , computer system validation .3 Knowledge of statutory compliance of cGMP , GxP , Regulatory requirement of EH & S.4 Familiar with regulatory inspections like USFDA, MHRA, WHO, etc.5 Monitoring of Break down of all production equipments & utility equipments for Mech & Elec.6 Monitoring of Capex from selection of equipments,Installation,commisioning & Qualification.7 Audit trail review of all computer based systems.8 Knowledge of Calibration of analytical & Digital instruments,SAP,SABA,QAMS.Work Experience10 to 15 yearsEducationB.Tech in Mechanical EngineeringCompetencies
