Senior Manager
NewJob 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