- Prepare and execute URS, DQ, IQ, OQ and PQ documents for equipment, systems and facilities.
- Coordinate qualification of injectable manufacturing and packing equipment.
- Perform qualification of HVAC, purified water, WFI, compressed air, clean steam and other critical utilities.
- Ensure qualification activities are performed as per approved protocols and SOPs.
- Review qualification reports and ensure proper closure of observations/deviations.
Process Validation
- Prepare and execute Process Validation Protocols and Reports for injectable products.
- Coordinate validation batches with Production, QA, QC and Engineering.
- Monitor critical process parameters and critical quality attributes during validation.
- Evaluate process trends and establish process consistency.
- Support continued process verification (CPV) activities.
Cleaning Validation
- Prepare and execute Cleaning Validation Protocols for manufacturing equipment.
- Identify worst-case products/equipment for cleaning validation.
- Coordinate swab and rinse sampling with QC.
- Evaluate cleaning validation results and prepare reports.
- Ensure validated cleaning procedures remain effective after changes.
Sterilization & Aseptic Process Validation(Optional)
- Support validation of autoclave/sterilizer cycles and sterilization processes.
- Coordinate media fill/aseptic process simulation activities with QA and Production.
- Support validation of depyrogenation tunnels/ovens, where applicable.
- Support filter integrity testing and sterilizing filtration validation.
- Ensure critical sterilization parameters are properly documented and evaluated.
Environmental & Facility Qualification
- Coordinate qualification of cleanrooms and controlled areas.
Support testing of:
- HEPA filter integrity
- Air velocity
- Air changes
- Differential pressure
- Temperature and RH
- Recovery time
- Airflow visualization/smoke study
- Microbiological environmental monitoring qualification, where applicable
- Process simulation (Media Fill activity)