Quality Assurance Engineer

Zydus Lifesciences; Solan; On-site; INR 600,000 - 900,000; Full time

Job summary

Zydus Lifesciences in Solan, Himachal Pradesh, seeks a Quality Compliance professional to ensure cGMP/GDP adherence and data integrity across engineering, maintenance, and facilities. The role includes reviewing SOPs, calibration records, and audit trails to uphold site standards and regulatory compliance.

You will oversee documentation, CAPA implementation, and change control within Engineering, ensuring continuous improvement and compliance across utility systems and warehouse logs.

Qualifications

• Experience in QA/QMS processes and data governance.
• Knowledge of regulatory standards (cGMP/GDP) and site SOPs.
• Attention to detail and strong documentation skills.

Responsibilities

• Review and ensure data integrity across electronic records and logs.
• Oversee preventive maintenance and calibration activities for utility systems.
• Verify calibration records, SOPs, and maintenance checklists for compliance.
• Support change control and CAPA implementations in Engineering.
• Participate in investigations of deviations and incidents and document findings.

Skills

Data integrity

cGMP compliance

Documentation review

CAPA handling

Job description

1. 1. To ensure service floor compliance to cGMP and GDP in technical area/utility area/equipment up keeping.
2. 2. Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.
3. 3. Responsible daily oversight of document destruction process.
4. 4. Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.
5. 5. To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms as per site SOP.
6. 6. To ensure compliance to preventive maintenance/ calibration planner.
7. 7. To verify equipment preventive maintenance checklist and its execution.
8. 8. To supervise Annual maintenance contracts of specified equipment and technical agreement with the service providers.
9. 9. To review SOPs of engineering department and ensure compliance.
10. 10. To verify qualification /validation activities of all Utility systems and continuous performance.
11. 11. To evaluate and comment on change proposals/ deviation and other applicable QMS documents initiated in the area of operation.
12. 12. To review the calibration records of equipment/instrument (other than QC).
13. 13. To review maintenance requests and ensure the completeness with respect to compliance.
14. 14. To verify the daily logs of, AHU/HVAC, Water system, Dust collector, Compressed air''.
15. 15. To review the filter replacements records and filter cleaning records.
16. 16. To review the Data logger’s calibration certificates of storage area of warehouse.
17. 17. To review calibration records of standards weights calibrated by outside party of balances of Engineering and Warehouse.
18. 18. To review SOPs of engineering department and ensure compliance.
19. 19. To ensure compliance to preventive maintenance/ calibration planner.
20. 20. To ensure compliance to Filter cleaning schedule and HEPA Filter Qualification Planner.
21. 21. To verify qualification /validation activities of all Utility systems.
22. 22. To verify the effectiveness of change control and CAPA implementation in Engineering.
23. 23. To participate in investigation of deviations and incidents in Engineering.
24. 24. To review and manage the User Access Management of Utility and warehouse equipment.