CSV Consultant

Role description Strong knowledge of Pharmaceutical Laboratory systems CSV covering the complete lifecycle including Requirements gathering SLRA Validation plan Specifications DS FS CS Functional Risk assessment IQ OQ PQ Validation report and Trace matrix Understanding of pharmaceutical network Infrastructure layers and its qualification Data center and all relevant network equipment including monitoring tools servers routers firewalls network switches cabling and end access Points Experience in Spreadsheets qualification Categorization IQ OQ Experience in validation of Laboratory Information management Systems LabVantage Hands on experience with ValGenesis validation tool Raising an ITCR with proper description reason for change implementation plan impact assessment and other requirements per customers SOP Reviewing and verify execution of ITCR Monitoring ITCR 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 Raising deviation processing investigation causal analysis implementation efficacy closure and other requirements per customers SOP Raising an IT CAPA initiation action processing root cause analysis Monitoring deviations and CAPAs for extension amendment approval and closure CreateReview requirements specification for compliance with the applicable regulatory requirements Knowledge of Patch management Write review evaluate the configuration management plans and procedures associated with the development process Conduct postimplementation periodic review of systems

Created: 2026-03-10