Job Description

1 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 Experience

10 to 15 years

Education B.Tech in Mechanical EngineeringCompetencies