Anil C Email & Phone Number

•Experienced in Computerized System Validation(QC Lab Application, Quality Systems and IT Infrastructure) with compliance to regulations and Industry Standards (GAMP 5; US FDA 21 CFR Part 11; EU Annexure 11).•Exposed to Qualification / Validation of Utilities and Equipment.•Adapted and well versed in documenting and executing GxP documents like URS, VP, Impact Assessment, IRA, FCS, IQ, OQ, PQ, TM, and VSR.• Experienced in IT Infrastructure qualification of servers, workstations and network components.Having experience in PLC Validation, Equipment Validation, Infra Qualification, BMS.•Experienced in QC Lab Applications Validation like Empower, Chromelieon, LabX, LabSolution, Mastersizer, TOC, WincAT, UV IR Manager, Rehocal-T, ICDAS, Spectra Manager.Testing and Execution of OQ protocols for Track and Trace application projects. Involved in the pre and post migration activity (GO Live) RA Manager, Track and Trace, Plant Maintenance and Material Tracking Project. Equipment validation of Pick and place automation for secondary line packing area.•Testing and Execution of OQ protocols for Online Artwork Management System (OAMS) application Project. •Execution of PQ protocols for different modules of LIMS application. Developing the DMD (Data Migration Document) for Chromeleon application. Execution of PQ protocols for DMS (Dossier Management System) application. Trained users on protocol execution and GDP.

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  Jain Institute Of Tech .Davangere