Umesh Rajani

Engineering graduate with post graduate in management having technical sound experience in the medical device industry , industrial automation mnc , project management and pharma software technology working as a validation lead in csv and leading a project of validation ,automation and remediation.

In the pharmaceutical background , role played towards Computer System Validation, Process Validation, Qualification of Equipment, Process Automated Equipment. developed and author documentations for computer System Development Life Cycle. SDLC methodologies , Documentation of Regulatory Compliance and FDA regulations 21CFR part 11, 211, and 820, GAMP 5 ,e-BMR , Validation protocols/reports (IQ, OQ, & PQ) , Serialization , Validation Master Plan, Configuration Master Plan, Retirement Plans, Test plans / scripts, requirements matrix and Validation summary reports. Controlling incident deviation and CAPA management

In medical device industry , author and executed IQ/OQ/PQ Protocols for both Pharmaceutical and Medical Devices Product ,Factory acceptance testing, device testing ,system setup, site acceptance testing ,installation and commissioning, packaging line ,validation offsite & onsite testing , audit trail, alarm reports , batch reports and startup assistance at various Projects at CVC Technologies Inc.