Joshna R.
Senior Consultant @Novo Nordisk
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WORK HISTORY
Senior Consultant @Novo Nordisk
Lead the end-to-end design, configuration, and implementation of Rockwell PharmaSuite MES to support production, quality, and electronic batch record (eBR) processes for GxP manufacturing. Work closely with Manufacturing, QA, IT, Validation, Automation, and Supply Chain teams to gather requirements, define user stories, and deliver scalable MES solutions aligned with business and regulatory needs. Manage the full MES project lifecycle—including URS/FRS development, system configuration, testing (IQ/OQ/PQ), go-live, hypercare, and ongoing sustainment. Designed, configured, and deployed Rockwell PharmaSuite MES modules, including workflow design, master recipe development, and electronic batch record (eBR) configuration to support GxP-compliant manufacturing. Develop and configure MES workflows, master recipes, and equipment models based on ISA-88 and ISA-95 frameworks to enable efficient batch execution and full traceability. Integrated PharmaSuite MES with SAP, LIMS, and SCADA/PLC systems, enabling seamless data flow, automated batch execution, and real-time visibility across production operations. Ensure full compliance with FDA 21 CFR Part 11, GxP, and ISO 13485 requirements through secure system design, electronic signatures, audit trails, and robust validation documentation. Lead Computer System Validation (CSV) activities, including test script creation, execution, deviation management, and support for system qualification. Troubleshoot MES issues, perform root-cause analysis, and support deviation and CAPA processes to minimize downtime. Support multi-site MES rollouts using global templates, ensuring proper configuration, testing, and validation for each site. Contribute to digital transformation initiatives such as paperless manufacturing, real-time batch visibility, advanced analytics, AR/low-code MES enhancements, and data-driven process optimization.
EDUCATION
Acharya Nagarjuna University
Bacherlor's, Computer Science
ABOUT JOSHNA R.
Senior MES Specialist at Lantheus
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