Role & responsibilities

Engineering & Utility Compliance

- Quality oversight of Engineering and Warehouse operations.
- Review AHU, HVAC, Water System, Dust Collector, and Compressed Air logs.
- Ensure compliance of utility systems with cGMP requirements.
- Review preventive maintenance and calibration schedules.
- Supervise Annual Maintenance Contracts (AMC) of equipment.
- Verify technical agreements of service providers.

Qualification & Validation

- Review and verify Qualification & Validation activities.
- Ensure continued validated state of utility systems.
- Support equipment qualification and requalification activities.
- Review HEPA filter qualification and utility system validation records.
- Monitor qualification status of critical engineering systems.

Calibration & Maintenance Review

- Review calibration records of instruments and equipment.
- Verify periodic calibration of balances and instruments.
- Review preventive maintenance records and checklists.
- Ensure compliance with calibration and maintenance planners.





Data Integrity & Electronic Records

- Ensure compliance with Data Integrity policies.
- Review PLC, SCADA, Audit Trails, Electronic Records, and Alarms.
- Verify user access management for utility and warehouse equipment.
- Daily review of data logger records for temperature and humidity monitoring.

Quality Systems

- Review Change Controls, Deviations, CAPA, and QMS documentation.
- Participate in investigations related to deviations and incidents.
- Evaluate engineering-related compliance risks.
- Ensure implementation effectiveness of Change Control and CAPA.

Documentation & Compliance

- Review engineering SOPs and ensure implementation.
- Verify logbooks and contemporaneous documentation practices.
- Oversee document destruction activities.
- Review maintenance requests and compliance records.
- Verify scrap management records.

📌 Officer / Executive - QA Engineering Qualification & Validation (Baddi)
🏢 Zydus Lifesciences
📍 Baddi