Yashwanth Mouli Pathipati

About Yashwanth Mouli Pathipati

8+years of experience in the Life Sciences industry with self-assured responsibility in the Pharmaceutical domain with emphasis on Computers Systems Validation in compliance with FDA guidelines. Experience in Validation with expertise in Computer System Validation, Software Development Lifecycle in healthcare industries with good knowledge of FDA regulations such as 21 CFR part 11 and GAMP5. Specialties: Computer System Validation, Software Development Project Management, GxP Compliance, Veeva Vault for QDMS, Change management systems. Established the key deliverables of computer and automated Validation, User Requirement specification (URS), Functional Requirement Specification (FRS), Validations Plans, cGxP Impact risk assessment, Reviewing technical documentation Design Specifications (DS) and Configuration Specifications (CS). Experience in and authoring the Report Specifications (RSpec) and reviewing, modifying Standard Operating Procedures (SOP’s) and work instructions (WI). Authoring validation documents IQ/OQ/PQ including Validation Project Plan (VPP), Validation Summary, Data Migration Protocol/Summary, and Requirement Traceability Matrix (RTM) Etc. Experience in MS Word, Excel, Power point and Windows based applications.

Experience

1. Csv Engineer Eln System Administrator

   Gilead Sciences

   Aug 2022 — Present · Foster City, CA, US

   Administrator, configure and maintain the Electronic Laboratory Notebook (ELN)application to ensure optimal performance and functionality.• Responsible for planning, coordination, and execution of ELN applicationupgrade configurations, including assessing new features, testing, and deploymentto enhance system capabilities.• Provide technical support to users, troubleshoot issues, and ensure smoothapplication operation.• Support data integrity, security, and access control within the ELN system.• Collaborate with IT teams and application vendor to integrate ELN applicationswith other laboratory systems and ensure seamless data exchange andinteroperability.• Customize and configure the ELN application, including design templates, forms,and workflows to meet the specific user requirements.• Monitor system performance, identify bottlenecks or areas for improvement, andimplement optimizations to enhance efficiency and user experience.• Maintain documentation of system configurations, procedures, andtroubleshooting guidelines. Generate regular reports on system usage andperformance metrics.• Implement change requests for new enhancements or bug fixes and provideproduction support.• Interact frequently with the system manager and stakeholders to use the ELNsystem efficiently.• Coordinate with Infrastructure, IT, and Database administrators to ensurecontinuous system availability.

Education

• Wilmington University

  Master’s Degree, Information Technology

  2015 — 2016

• Jawaharlal Nehru Technological University

  Bachelor of Technology (B.Tech.), Electrical and Electronics Engineering

  2007 — 2011