Leela Gurudas C. Email & Phone Number

West Haven, Connecticut, United States

Waltham, Massachusetts, United States

- Generated qualification protocols and reports, assessing critical parameters related to the installation, operation, and performance of utilities, instruments, and equipment.- Proficient in using Kneat Gx to generate, review, and approve system lifecycle documents, as well as submit general work orders related to systems via BRAM.- Authored and revised system lifecycle deliverables, including System Impact Assessments, Data Integrity Assessments, User Requirements Specifications (URS), Validation Plans, IQ/OQ/PQ Protocols, Trace Matrices, and Validation Summary Reports.- Systems managed include: - Analytical Instruments: MiniCapt, STEMvision, MSD Plate Reader, TOC Analyzer, etc. - Equipment: CTUs (Refrigerators, Freezers, CO2 Incubators, Micro Incubators, CryoPods), Visual Inspection Booths, Kaye AVS, Bio Safety Cabinets, etc. - Utilities: Process CO2, N2 & CA gases, Water for Injection (WFI) System - Facilities: CRT & Warehouse Mapping, AVS/Recovery Studies for Grade C Airlocks- Collaborated closely with engineering teams to ensure successful system lifecycle management from installation through decommissioning.- Supported revalidation and periodic review efforts for regulated systems, ensuring compliance with quality and regulatory standards.- Contributed to site capital projects and improvement initiatives by generating system impact assessments and validation deliverables for new equipment and instruments.- Worked cross-functionally with Engineering/Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.