Hemantha Kumar V Email & Phone Number

CURRENT JOB PROFILE: LIMS Master • Responsible for operations of Caliber LIMS 3.3.0.E (Laboratory Information Management System) - used as electronic data management system with instruments and QMS interface for Quality Control activities. • Preparation of LIMS SOP’S, test scripts, protocols, reports and all such other documents at various phases of LIMS qualification and implementation.• Experience in preparation and review of URS, GxP Assessment, Supplier assessment, System Validation Plan, Functional specification, Functional Risk Assessment, IQ, OQ, PQ, Traceable Matrix and Validation report.• Involved and executed the qualification activities like IQ, SAT, OQ and PQ. • Responsible for custom field’s creation in EMPOWER for LIMS interface.• Working knowledge of GxP, GAMP V guidelines especially in the areas of computer or related systems.• Responsible for creation of Masters Data in LIMS for laboratory usage to in line with regulatory requirements.• Coordinating and providing training to team members and plant users on Sample Manager, Resource Manager and System Manager.Technical responsibilities:• Requirements gathering from operations and assess the technical feasibility w.r.to enterprise applications.• Prepare & review validation documents of enterprise applications• Perform testing of application in various environment• Provide demo of the application to the end user before Initiation of PQ activities.• Provide training to end users on application operations.• Perform Risk & impact assessment for changes in operation phase• Provide support to end users Post Live in production build.• Assess the application w.r.to continues improvement based on operation.• Provide support in preparation of procedure related to application operations• Coordinate with application vendor for validation documents review & approval.• Coordinate with application vendor for issues/bugs /enhancement.

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  Andhra University

  Organic Chemistry