Bhanusri Nadella

Background

About Bhanusri Nadella

IT professional with 8+ years of experience in life sciences domain.• Good understanding of E2B R2, R3, ICH, PMDA, EMA, GDPR, FDA guidelines, 21 CFR Part-11 and regulations.• Experience in working on CSV and technical roles.• Proficient in maintaining GxP compliance for computer systems.• Experience in working on waterfall and agile methodologies.• Experience in handling deviation, CAPA and risk management.• Experience in authoring, reviewing and approving CSV documents like URS, CS, FS, DS, IQ, OQ, PQ, impact assessment, change control, IQ/OQ/PQ plans and reports, validation plan, RTM, VSR etc.• Experience in Argus Safety configurations, complex customizations.• Experience in handling workshops for requirements gathering, solution design, development and testing of various regulatory and business requirements.• Experience in supporting internal and external audits and providing support to customers in regulatory authorities, partners audits and ISO audits.• Good understanding of Argus Safety, LSMV database architecture and tables.• Experience in working on MedDRA and WHODD dictionaries management.• Experience in conducting data migration workshops for requirements gathering and data migration mapping document preparation.• Experience in data migration code development and testing.• Experience in development and review of line listings using SQL/PLSQL and from reporting tools like BI Publisher.• Experience in working on operations and consulting projects.• Experience in performing root-cause analysis and defining corrective and preventive measures for validation incidents.• Good knowledge on service desk applications for support tickets and following SLA timelines.