Sheeba Rani Email & Phone Number

Over 7+ years of experience in Pharmaceutical, Biotech Industry with Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control Management and Implementation of business applications. Reviewed and Validated Computer Systems in Compliance with 21 CFR Part 11 and GxP FDA Regulations.Abundant Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA Regulations for Pharmaceutical IndustriesWorking Knowledge of GLP, GMP, GAMP5 guidelines especially in the areas of computer and related systems. Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol deviations, Risk Assessment, Decommission report, Periodic review report.Experience in reviewing all SDLC documents, protocols, and SOPs to ensure they meet GxP and FDA regulations.Excellent Knowledge and Experience in Good Documentation Practices. Demonstrated capability to quickly gain a detailed understanding of process in order to optimize efficiencies and improve quality.