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.