Role & responsibilities :

1. Ensure compliance with cGMP requirements, Good Engineering Practices (GEP), and applicable statutory laws, rules, and regulations.

- Ensure legal and statutory compliance as per applicable norms for Boilers, Electrical systems, and other utilities.
- Ensure timely execution of preventive maintenance schedules for Utility and HVAC systems in close coordination with cross-functional teams (CFT).
- Ensure all periodic and breakdown maintenance activities are completed within minimum downtime.
- Manage spares inventory, including PR/PO processing as per approved procedures.
- Ensure training and skill development of the engineering team to minimize downtime and avoid non-compliance.
- Liaise with Government authorities such as Boiler Inspector and other statutory bodies as required.
- Work in close coordination with cross-functional teams for smooth planning, execution, and handling of new systems.
- Manage QMS activities related to the Engineering/Utility department.
- Participate in monthly Quality Review Meetings (QRM).
- Monitor and track performance and efficiency of Utility and HVAC equipment and implement energy-saving initiatives.
- Review observations and non-compliances identified during internal and external audits.




- Prepare and submit audit responses in coordination with the QA department.
- Track and follow up on audit observations to ensure timely and effective closure.
- Review qualification documents such as URS, DQ, IQ, and OQ for recent equipment and systems.
- Review and approve engineering drawings and technical documents.
- Execute project activities as per approved plans and requirements.
- Monitor and review legal compliance status of the Utility department and ensure timely renewals and submissions.
- Ensure adherence to GDP, GEP, and cGMP practices during all utility operations and maintenance activities.
- Provide training, guidance, and performance feedback to subordinates.
- Report critical operational issues to higher management and provide regular updates on corrective actions.
- Carry out any additional responsibilities assigned by management.
- Ensure strict adherence to safety practices during utility operation and maintenance.
- Review, monitor, and ensure calibration of utility-related equipment and instruments.
- Oversee building and civil maintenance activities as and when required.
- Perform all tasks assigned by the reporting manager in line with organizational requirements.

📌 Deputy Manager (Injectables Pharma Plant Experience Only) (Udaipur)
🏢 Cadila Pharmaceuticals
📍 Udaipur