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 - Mechanical
Required Experience:12 - 15 years
