Chromeleon CDS, Empower CDS, Analytical Instrumentation, Computer System Validation:● Total 13 years of experience with 10+ years’ experience in Analytical Instrumentation, Chromatography Software’s, Lab Software’s & Customer Support in FDA regulated Pharmaceutical Industry.● Installation and Qualification (IQ/OQ) of Chromeleon CDS Application (Version 6.8, 7.2) & EndoscanV application (version 6.0.2) on Instrument client, Remote Client, Application server and Terminal Server.● Good Understanding of Empower CDS application Installation, Operation & administration. ● Configuration and Troubleshooting issues of HPLC and GC Chromatography Instruments from different vendors (Thermo Fisher, Agilent, Shimadzu, Waters & Perkin Elmer) with Chromatography software like Chromeleon & Empower. ● Experience in designing periodic calibration Protocol (PQ) for Chromatographic instruments. ● Finalization of the User Management (Roles, Privilege’s, Global Polices) as per business requirements.● Creation and Review of CSV documents such as URS, FS, CS and Risk assessment (FRA).● Creation and Review of IQ, OQ and PQ scripts for CDS and other Lab Software Validation.● Execution of IQ. OQ and PQ scripts in HP ALM software as well as with Hardcopy documentation method following all required good documentation practices. ● Good Understanding of Networking Components (Firewall, Router switches), Database servers, Application/Raw data servers and Terminal servers which is required for troubleshooting the issues occurred in software applications implemented in Client Server architecture.● Experienced in investing issues, Incidents and Deviations occurred in CDS software and Chromatography instruments, providing CAPA along with taking required corrective and preventive actions.● Creation and closure of Change controls during implementation of newer versions of software. ● Verification and Support during creation of different operational and administration SOPs of Instruments and Lab software’s. ● Familiar with ERES regulatory guidelines like 21 CFR Part 11. Also familiar with Regulatory requirements like EU Annexure 11 & GAMP 5.● Expert in providing training to End Users on Operation of Chromeleon Application, Waters HPLC instrument and EndoscanV application. ● Attended Regulatory Audits (USFDA, MHRA, WHO) and resolved queries of regulators related to Chromeleon Application.● Creation of the Customized report templates in Chromeleon application for different types of QC Analysis like Assay, Dissolution, CU, BU, RS and RSL.