Raghu Raj Sharma
Validation Consultant @Denali Therapeutics
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WORK HISTORY
Validation Consultant @Denali Therapeutics
San Francisco, CA, US
EDUCATION
Malaviya National Institute of Technology Jaipur
Bachelor of Engineering (B.E.), Computer Engineering
SKILLS
ABOUT RAGHU RAJ SHARMA
Over 16 years of experience in IT industry, 10+ years in computer system validation (CSV) experience, working for Gilead Sciences Inc, Biogen, AbbVie, Merck, Schering-Plough and Covance.• Various roles played are Program Test Management, Validation Manager, Validation Lead & Test Lead• Managed Testing Center of Excellence (TCoE) with annual billing revenue over $5 Million. Experience in Service Initiation, Standardization & Stabilization • Well versed in a global delivery business model, onsite & offshore engagements• Managed customer account including financial, contracts, SOW, change requests, project margins/profitability• Managed a program/project delivery and various aspects of program/project managements – demand, resourcing, estimations, project planning (scope, cost, time), risk/issues, mitigations, metrics, client meeting, various status reporting• Prepared and reviewed validation plan & risk management plan (RMP) as per GAMP 5 risk assessment techniques• Reviewed design, user/functional requirement specifications per 21 CFR Part 11• Performed risk assessment on user and functional requirement specifications as per RMP• Prepared and reviewed installation, operational and performance qualification protocols (IQ/OQ/PQ) based on good documentation practices. • Prepared and reviewed traceability matrix, validation summary report• Performed deviation/discrepancy management and managed defect triage meetings• Supported Production release testing, Hyper-care support after production release, Change Management• Established various testing processes, best processes & quality standards • Performed full range of test activities: functional manual & automation; integration, migration & UAT• Hands-on & technically savvy; good in analytical, communication & interpersonal skills
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