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.