Group Leader

Job Description

Purpose of the role: Responsible for all areas of the Engineering function of DS block and Water System. Primary Responsibility: Strategic: • To conduct Periodical plant energy audits to improve the efficiency of the system & to bring down the operating cost. • Plant upgradation works planning, execution on periodical basis. • Plan & work towards the target set by the management based on business needs. • Updated & aware of cGMP requirements. Operational: • Operation & Maintenance of Utility equipment’s – Boiler, Chiller, Hot water system, Cooling tower, Air compressor, Pumps, Valves, Piping system. • Operation & maintenance of clean Utility equipment’s: Raw water storage & Distribution system, Water Pre- Treatment system, Softener, Purified water generation, Water for Injection generation, Pure steam generation along with Storage & Distribution system. • Attend to Preventive & Breakdown maintenance for Plant & Process equipment’s related to Drug product- Filling lines, Autoclaves, Manufacturing/ Filtration vessels, CIP, SIP, TCU, Autoclaves, Packing machine, etc. Drug Substance- Fermenters, Centrifuges, Homogenizers, HPLC columns, Filtration vessels, CIP, SIP, TCU, Autoclaves, etc. • Gas distribution systems. • Mechanical maintenance support Fire protection systems. • Mechanical support for ETP & STP. • HVAC, BMS, EMS systems. • Good Documentation practices. • Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. • Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. • Knowledge of plant safety & cGMP requirements. Audit & Statutory Compliance. • Coordination with user departments & plan for Preventive/Breakdown maintenance. • Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. • Plan for required spare parts inventory & AMC. • Shift scheduling, Manpower planning & reporting. • Computer skills including Auto CAD, Microsoft Projects. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. • Goal settings to team members & annual review. Providing the same to department head for review & approval. • Responsible for handling of controlled documents such as SOP’s, logbook and qualification protocol etc., • Responsible to ensure preventive maintenance of the equipment is completed as per schedule and review the preventive maintenance schedule as per SOP. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ including EDMS documentation