Officer / Executive - QA Engineering Qualification & Validation

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.