Associate

Job 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.
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 / HVAC & Utilities operational and validation activities and ensure compliance to cGMP and quality system. Maintain and ensure validations carried out as per planner.
4. 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. Review of operational log books and reports daily basis.
7. Analysis of breakdown notifications.
8. Maintaining and procurement of critical spare parts.
9. Maintaining UPS & electrical panels in safe and compliance condition.
10. Tracking allocated QMS task completion and closer within time.
11. Ensure compliance to cGMP and quality system.
12. Exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc.
13. Ensuring Compliance of safety policies, safe work environment for all the team members, external party, contractors etc.
14. Legal compliance with respect to safety & environment, licensing with government authorities.

Work Experience

3 to 5 years

Education

Competencies