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Job Description:The candidate should have knowledge about Parenteral / Injectable experience To handle Utilities (Chiller, AHUs, Water system, PSG, Compressed air, Nitrogen and Electrical) To maintain the process equipment's in validated state, PM schedule, calibration schedule, Qualification of AHU, Qualification of Water system, Qualification of BMS, EMS, Qualification of Steam, Qualification of Chiller Preparation, review and approval of SOPs, Protocols, technical rationale documents and Handling of QMS documents like change controls, CAPA, deviations and other quality documents, whenever required as per GDP. Adherence to standard operating procedures, Safety, cGMP, GDP, GEP and EHS requirements. Faster effective communication both within the team and with other departments to ensure smooth operations and coordination. Efficiently allocate resources, including personnel and other resouces to meet production goals. Co-ordination for audits (Internal and external) related to Engineering and QMS. Inventory management, Vendor identification, Request for Quotations, Placing Purchase Requests for spares, equipment and service. To maintain minimum breakdown time and ensure the maximum availability of Equipment for production usage. Adherence to Preventive Maintenance and Calibration schedules. Cost optimization in the entire phase of the project, while selection of equipment, process optimization and sizing. Address and resolve any issues or challenges that arise during production process promptly and effectively. Implementation of energy conservation measures and also need to coordinate with external agencies for AMC/CAMC activities. Planning and execution of different types of maintenance of equipment and its accessories in co-ordination with users. Handling Training requirements. Should have sound knowledge on SAP PM & Breakdown Maintenance module.Required Education Qualification: B Tech / B.E - MechanicalRequired Experience: 12 - 15 years
