Implementation of planned preventive maintenance with effective engineering technique to ensure availability of machines for production & utility at all time.
cGMP documents Preventive maintenance checklist/Plan, Facility maintenance checklist/Plan, Calibration report/Plan, URS, Qualification documents like - SOP, Training, Area validation, Change control, Deviations, Water system reports etc.
All activities of maintenance department (Machine/Facility inspection & maintenance, Calibration etc.) should be carried out as per the SOP or other GMP document.
Internal audit of engineering department & its compliance.
Regulatory audits Local FDA, WHO, USFDA, UKMHRA etc.
Compliance to Regulatory audits for points related to maintenance department.
Maintain inventory and arrangement for spares, hardware, tools etc.
Facility maintenance of plant (civil, painting, plumbing etc.)
Dealing with local government authority such as Electricity board, Factory Inspector, Pollution Control Board and Industrial Development Corporation etc.
Keep the track of electricity and water consumption and take corrective action in case of any abnormality
On job training to subordinates.
Facility up gradation and efficient utilization of installed capacity.
Dealing with external agency and contractors, review of maintenance contracts with AMC parties.
Salary: INR 4,25,000 - 9,25,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Employment Type: Permanent Job, Full Time