1. Ensure compliance with cGMP requirements, Good Engineering Practices (GEP), and applicable statutory laws, rules, and regulations. 2. Ensure legal and statutory compliance as per applicable norms for Boilers, Electrical systems, and other utilities. 3. Ensure timely execution of preventive maintenance schedules for Utility and HVAC systems in close coordination with cross-functional teams (CFT). 4. Ensure all periodic and breakdown maintenance activities are completed within minimum downtime. 5. Manage spares inventory, including PR/PO processing as per approved procedures. 6. Ensure training and skill development of the engineering team to minimize downtime and avoid non-compliance. 7. Liaise with Government authorities such as Boiler Inspector and other statutory bodies as required. 8. Work in close coordination with cross-functional teams for smooth planning, execution, and handling of new systems. 9. Manage QMS activities related to the Engineering/Utility department. 10. Participate in monthly Quality Review Meetings (QRM). 11. Monitor and track performance and efficiency of Utility and HVAC equipment and implement energy-saving initiatives. 12. Review observations and non-compliances identified during internal and external audits. 13. Prepare and submit audit responses in coordination with the QA department. 14. Track and follow up on audit observations to ensure timely and effective closure. 15. Review qualification documents such as URS, DQ, IQ, and OQ for new equipment and systems. 16. Review and approve engineering drawings and technical documents. 17. Execute project activities as per approved plans and requirements. 18. Monitor and review legal compliance status of the Utility department and ensure timely renewals and submissions. 19. Ensure adherence to GDP, GEP, and cGMP practices during all utility operations and maintenance activities. 20. Provide training, guidance, and performance feedback to subordinates. 21. Report critical operational issues to higher management and provide regular updates on corrective actions. 22. Carry out any additional responsibilities assigned by management. 23. Ensure strict adherence to safety practices during utility operation and maintenance. 24. Review, monitor, and ensure calibration of utility-related equipment and instruments. 25. Oversee building and civil maintenance activities as and when required. 26. Perform all tasks assigned by the reporting manager in line with organizational requirements.
