Vijaya Raman M(ビジャヤラマン) Email & Phone Number

• 8 years of working experience on Manufacturing Execution System (MES) implementation/deployment of HITPHAMS along withComputer System Validation (CSV) for the pharmaceutical industry.• Worked on external systems interfaces such as SAP, LIMS, Equipments (OPC), Weighing balances.• Well versed in pharmaceutical industry best practices, compliance requirements, GAMP5, 21 CFR Part 11, S95 standards, etc.• Good exposure to working at the client’s location (75% traveled).• The key activities of this project are Weighing and Dispensing(warehouse and inventory management), EBR, packaging, and theconfiguration of master data and workflows.• I worked with the site SMEs to gather and understand the business requirements, manufacturing processes for making recipesand system configuration.• Created a new web application (Mieruka), to handle the historian data and generate customized reports, APQR/ePQR reports and thissystem is integrated with the MES application.• Protocols are documented properly before development of the requirement as it helps to develop the feature easily.• Possessing a sound knowledge of SDLC management, SQL, Oracle, ORM.• Hands-on experience on networking, configuring the system in client-server architecture, NLB to maintain a high volume ofclients for optimal solution.• Created design documents for the new features and integration methodology.• Developed new features for the existing system. Created and executed IQ, OQ, and PQ scripts and protocol documents.• Responsible for specification documents and delivery.• Experience in the documentation: Workflow, Design document, FRA, Configuration specification, Interface document, Functionalspecification, Hardware specification, Table specification, etc.• Work closely with customers to address priorities, schedule meetings, maximize productivity, reduce costs, and increaseefficiencies.• Manage team members on tasks and check the progress of tasks every day in meetings.• The project schedule document will be shared with the customer once weekly.• Deliver the specification documents to the customer as per schedule.