Job Description

Responsible for plant utilities operation and facilities maintenance (HVAC, electrical system, water system, infrastructure services) within regulatory guidelines and good engineering practice. Good knowledge of Water system operation (RO plant, EDI , PW loop, MGF and ozone system) as per Pharmaceutical requirement and WHO guideline. Good knowledge of Operation of screw air compressor, reciprocating air compressor and air dryer along with compressed air testing as per ISPE medical gases and ISO 8573 standards. Responsible for operation and maintenance of HVAC, Chiller, cooling tower and Hot water system. Knowledge of HVAC validation as per ISO guideline and other pharmaceutical requirement. Knowledge of plant maintenance in OSD pharmaceutical is preferred like Coating machine, RMG, Compression machine and FBP/FBD. Plan and support resources to operate utilities and ensure 24 X 7 continuous system operation to support plant activities. Ensure all time audit readiness by complying with effective standards, regulatory/statutory and cGMP requirement to protect product and prevent major compliance observation. Review and approve the utilities log sheets and work orders for compliance with quality requirement. Knowledge of QMS system like Trackwise, change control and SOP preparedness. Provide engineering support, organize and implement routine PM and yearly schedule shutdown. Train and develop maintenance employees, upgrade their capability continuously. Assist maintenance manager to ensure maintenance team compliant with GMP requirement. Establish spare part list and effective inventory level to ensure maximum equipment uptime of Utilities System. Manage operation and maintenance service contracts to ensure Utilities systems are operated and maintained in accordance with regulatory, quality, ESH and budgetary requirement to sustain safe, reliable and efficient utilities operations. Lead/Participate in discrepancy management process, identify root cause, implement corrective & preventive measures and drive records for timely closure. Ensure CAPA is in place for any deviations to prevent future recurrence incident. Support Engineering, site expansion and other and projects. * Undertake tasks assigned by leaders as and when appropriate