I have the brain of an engineer, the heart of a designer, and the speech of a diplomat. With over 13 years of experience across pharmaceuticals, biotechnology, medical devices, and biomedical technologies, I specialize in driving digital transformation by connecting People, Process, and Data through Business Analysis, Product/Brand Quality, and Digital Solutions. As a Thought Leader in the Life Sciences industry, I have a proven track record of analyzing complex business process requirements and delivering value through innovative product implementations and application developments, empowering businesses to evolve and thrive.Skilled in:• Product Management • Requirements Engineering - Translating business requirements into product-specific designs and configuration, detailed requirement specifications and use cases,• Agile framework and Practices - SAFe 5.1 and SCRUM. Creating Epics, Features and User Stories in JIRA. Backlog Refinement, Timeboxing,• UI Prototyping, Release Planning, Business Requirement Doc, • System Integration (Point-to-Point, Vertical and Star),• Workflow Designing and Configuration – Sequential, State Machine and Rule Driven • Legacy Data Migration – Storage, Database, On-prem/Cloud to Cloud and Application Migration, • Defining and Validating Test Cases, • 21 CFR Part 11 Compliance app implementations adhering to HIPAA, EU GDPR, EU MDR 2017, DISHA, ISO 13485:2016 - QMS,• GAMP 4 and 5 Computer Software Validation Support (GxP), • Product Demonstrations and Trainings.• Managing and prioritizing the product backlog, translating product strategies to development tasks, and learning the customers' and market's requirements.Implementations :• Honeywell Recall Management • Honeywell Annual Product Quality Review • Clinical Trial Management Systems in Contract Research Organization (CRO)• Electronic Document Management System in Manufacturing and Formulations site• Quality Management System processes• User ID Management with RPA-Automation Anywhere• SAP Integration – Materials Management (Create, Block, Unblock, Extend Vendor and Materials Master) Sales and Distribution (Create, Block, Unblock, Extend Customer Master) • Vendor Q-Score SAP• Management of Integrated database & Tracker for Regulatory Affairs• Pharmacovigilance• Bio-Pilot & Study Pivotal• Operational Excellence – DISHA and Six Sigma web applications redesign• R&D Timesheet• Product Lifecycle Management• Product License Management
Listed skills include Analysis, Software Development, Seo, Market Research, and 18 others.