AddressRoles and Responsibilities:
- Managing maintenance for OSD utilities, plant equipment, electrical systems, instrumentation, calibration, HVAC, civil design, and overseeing overall site engineering operations, with expertise in handling large volume projects.
- Evaluate instrument/equipment/calibration points in the SAP system for calibration, preventive maintenance, and breakdown maintenance.
- Implementing energy conservation strategies for power and fuel cost reduction
- Achieving optimal plant machinery utilization through the development and implementation of new technologies.
- Coordinating with corporate engineering for the implementation of utility modification, renovation, and cost reduction projects.
- Reviewing the maintenance of ASRS and machinery
- Managing Trackwise, LMS, SAP, Documentum, and EDMS software.
- Monitoring and maintaining ETP/MEE.
- Coordinating with government bodies related to Boiler, PCC, DNH Power Distribution Corporation Limited, etc.
- Implementing cGMP practices, GEP practices, and introducing energy-saving initiatives.
- Reviewing and approving the investigation, root cause identification, and CAPA derivation for system failures, out-of-specification observations, change control, and action items through the Trackwise (QMS) system.
- Ensuring compliance with internal audits, external audits, and addressing visit observations.
- Coordinating with corporate engineering for monthly and quarterly reports.
- Ensuring compliance with all EHS (Environment, Health, and Safety) requirements
- Reviewing the operation of EMS/BMS systems.
- Ensuring vendor services align with AMC schedules.
Candidate Profile:
- Preferred candidate should have a background exclusively in the Pharma Industry, with specific experience in Oral Solid Facility operations.
- Preferred candidate should have experience in managing engineering and maintenance activities for a Large Volume block.
- Desired candidate should possess exposure to regulatory audits, specifically with experience in USFDA audits.
