Senior Executive

Long Description

1. Assign and coordinate with external vendors and execute the HVAC & Utilities validations as per planned schedule with coordination of user departments. Develop good rapport with external agencies to ensure validation of system is in place on time and ability to lead team of 5 to10 members.
2. Develop and maintain accurate, efficient HVAC & Utilities operational and validation procedures. Keep abreast of the latest amendments as per ISO14644 and other regulatory standards.
3. Implementation and review of departmental documentation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time.
4. Lead continuous improvement initiatives in the HVAC & Utilities to increase process efficiency, energy conservation and capacity while maintaining a high level of quality.
5. Should have hands on experience in HVAC / BMS / EMS / Air compressors / Air Dryers/ Heat Pumps /Brine chillers / Chillers / Cooling Towers etc.
6. Analysis of breakdown notifications. Maintaining and procurement of critical spare parts.
7. Preparing and renewal of annual maintenance contracts with external agencies.
8. Maintaining UPS & electrical panels in safe and compliance condition.
9. Ensure compliance to cGMP and quality system.
10. Develop and train the HVAC & Utility staff on procedures and validations. Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc.
11. Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department.
12. Legal compliance with respect to safety & environment, licensing with government authorities.

Competencies

Education

Work Experience

6 to 8 Years in Injectable HVAC & Utilities lead position