Vinay T Email and Phone Number

Professional Summary : I have around 4 Years of professional work experience in IT industry as a LIMS consultant, this includes 1.8 year of experience in Pharma Domain as a LIMS Consultant at Satyam Computer Services Limited, 8 months of experience in Pharma Domain as a LIMS Consultant at Wipro Technologies and 1.5 years of experience in Bridge I Technologies as a QA. I have worked extensively in Labware LIMS, LabVantage LIMS(Sapphire LIMS), Crystal Reports and Other lab environment related applications like EMKA, GENDATA and SAMTRACK. I possess good understanding of GxP (GLP, GMP and GCP) and regulatory requirements including familiarization of FDA ‘21 CFR Part 11’ guidelines, Computer System Validation, Change Management, Incident and Problem Management I have Experience in all aspects of computer systems validation (CSV) lifecycle of Lab Software and Lab Instruments to comply with FDA regulations, particularly 21 CFR part 11. Good experience and knowledge in validation of Labware LIMS and CDS. I have excellent documentation skills including User Requirement Specifications (URS), Functional Requirements Specification (FRS), Test Plans, Test Cases, Validation Protocols, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Operational Qualification Summary and Test Summary. I have developed and designed  validation plans and testing protocols. I am also trained and worked with 2 Pharma majors Novartis, Pfizer and Kent Health care Ltd and possess good understanding of Life science domain and regulatory guidelines. I am also well versed with GxP, Pharma 101 and ITIL processes. I am well versed with RDBMS like Oracle and OS concepts. I possess good knowledge of SDLC. I have great passion of working on cutting edge technologies in software development and endeavoring to achieve this aim by working constantly everyday to improve the present stature and knowledge.