Injectable Experience is mandatory
- Knowledge of the QAMS System
- Preparation & review of MPCRs and eBMR
- Preparation & review of the SOP, Risk assessment, and Protocol (e.g. URS/DQ) of various equipment, facility, and utilities.
- Prepare, and review the audit report as per regulatory requirements.
- Handling of Change Control, Deviation, and Incident.
- Root cause analysis and effectiveness of Corrective & Preventive action for Compliance and implementation after recommendations.
- Preparation of Investigation and impact assessment.
- Preparation and review of investigation report generated by deviation.
- Coordinate with other departments to close the corrective & preventive ( CAPA) events against audit Compliance.
- Ensure cGMP & GDP compliance in routine activities per the current regulatory guidance.
Training to be provided to approve Protocol & SOP to all concerned department personnel