Injectable Experience is mandatory
Knowledge of QAMS System
Preparation & review of MPCRs and BMR
Preparation & review the SOP, Risk assessment and Protocol (. URS/DQ) of various equipment, facility and utilities.
Prepare , 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.
Coordination with other departments for closing the corrective & preventive (CAPA) of events against the audit Compliance.
To ensure cGMP & GDP compliance in routine activities as per the current regulatory guidance.