★ Bhanu is a salt and pepper combination of Pharmaceutical /LIMS / GLP/ IT-System(IT-QA/CSVC/Scientific application Support) / Lab Informatics professional with 17 years experience. He began his career in Pharmaceutical Research and Development, GLP/ CSVC(Computerized system validation), LIMS. ★ He is supporting the Pharmaceutical and Life science domain: Discovery Chemistry, Chemical Development, Analytical, Biology, Viral testing facility, Bio-analytical, Clinical, Quality Control, Discovery Biology. ★ He is supporting Pharmaceutical Scientific application: Chromeleon 7.2(Client-server), LIMS 7.4.1(Thermo Scientific), LC Solution CDS, Analyst Software CDS(AB Sciex) 1.5.1,1.6.1,1.6.2, Empower3 CDS(User management,Backup), Masslynx CDS ,4.1(waters). and standalone equipment software. ★Manage end to end IT project. ★Conduct audit of Computerized system validation and compliance as per Predicate Rule, GAMP5, US FDA (21 CFR part 11), Annexure 11 EU, USP Chapter 1058, under GXP environment. ★Contribute to take initiatives within Risk Management, such as Global Computerized system Risk Assessment for CSV projects, CAPA, Change management, Deviations, Lab investigations ★Preparation/Review of validation master plan for CSVC activity under GXP Environment ★Data Integrity and security for CDS System (Analyst, Mass lynx, Eurotherm, LIMS, Empower3, LC Solution,). ★ Identify the critical IT infrastructure components and procedure to data quality, accuracy and integrity.GXP critical: LAN, WAN, and Hardware supporting GXP application, Data storage, Security, and access. ★Knowledge of 21CFR Part 11/Annex 11, gamp5, GAMP Guidance for IT infrastructure control and Compliance and related regulations & guidelines. ★Accountable for Compliance of specific application deliverables such as validation master plan, validation protocols (DQ, IQ, OQ, PQ), trace matrix, and validation summary report. ★Contribute to take initiatives within Risk Management, such as Global Computerized system Risk Assessment for CSV projects, CAPA, Change management, Deviations, Lab investigations.  Project Expertise: Live Implementation Experience in LIMS-Watson, Chromeleon CDS-7.2 sr4 and sr5, Analyst 1.5, 1.6.2, Mass lynx 4.1, Tiamo, Eurotherm, Newtronics Chambers, SAS.9.2, ICPMS, and XRD-Diffrac.Suite EVA., PRISM, Biograph, Empower3 Mob: +91-8884243241, 9482464405 ✉ bhanu99@gmail.com