Role description
Strong knowledge of Pharmaceutical QMS Laboratory systems covering the complete lifecycle
Knowledge of handling Veeva Deviations and CAPA
Raising deviation processing investigation causal analysis implementation efficacy closure and other requirements per customers SOP
Raising an ITCR in ServiceNow with proper description reason for change implementation plan impact assessment and other requirements per customers SOP
Raising an IT CAPA and processing root cause analysis
Monitoring deviations and CAPAs for extension amendment approval and closure
Experience in validation of Laboratory Systems
Hands on experience with ValGenesis validation tool
ITCR Monitoring through closure
Good understanding of 21 CFR Part 11 and GAMP 5 and other GxP standards
Drafting and execution of qualification protocols
User access review
Create and Review requirements specification for compliance with the applicable regulatory requirements
Knowledge of Patch management
Conduct postimplementation periodic review of systems
