Richa Das

About Richa Das

Dynamic professional with 7 years of biopharma R&D(wet lab) and Information…

Experience

1. Business Analyst

   Cognizant

   Sep 2022 — Present · Kolkata, IN

   Hands-on expertise in Labware MDM and LabVantage LIMS, driving master data creation, user management, and product configuration to support laboratory digitalization and regulatory compliance. Authored and reviewed key validation deliverables (URS, FS, DS), ensuring traceability and strict alignment with business requirements and regulatory standards. Developed, authored, and executed Operational Qualification (OQ) scripts in ALM, validating critical system functionalities in compliance with GxP and 21 CFR Part 11. Partnered with cross-functional teams (QA, QC, IT, and business stakeholders) to streamline data governance, sample management, and workflow automation, enhancing efficiency and audit readiness. Supported the full system validation lifecycle, including requirements gathering, defect tracking, testing, and documentation, ensuring smooth outcomes during regulatory inspections. Improved system efficiency by driving seamless integration of Labware MDM with LIMS workflows, standardizing data structures, and reducing redundancy. Gathered and analyzed business requirements, translated them into Jira user stories, and ensured the timely delivery of functional solutions. Mapped method lifecycle for small molecules, biologics, and vaccines using Visio and ArchiMate, improving traceability and process transparency. Prepared end-to-end business process maps covering R&D, Manufacturing, Stability, and Analytical Method Lifecycle, enabling better process alignment across departments. Contributed to RFI/RFP preparation and developed domain-centric training materials, facilitating vendor evaluation and team upskilling.