Sambhu R

About Sambhu R

I am a Computer Software Validation (CSV) Engineer with over 7 years of experience across…

Experience

1. Implementation Consultant

   龙沙

   Sep 2024 — Present · Bengaluru, IN

   Implementation Consultant MODA EM-Managed the implementation and configuration of MODA EM application in client environments, ensuring alignment with user requirements and regulatory expectations-Participated in validation and verification activities by mapping user requirements to system functionalities, creating test cases, and documenting results to support GxP compliance-Assisted in the preparation of Validation Test Plans (VTP), Verification Test Plans, and Summary Reports, ensuring traceability of system functionality to user and product requirements-Coordinated system testing, feature testing, and workflow validation to ensure proper operation of electronic management systems in regulated environments-Supported installation, configuration, and administration of MODA EM application across multiple environments, including test, staging, and production systems-Collaborated with cross-functional teams, including developers, QA, and product owners, to resolve system issues and ensure compliance with 21 CFR Part 11, GxP, and data integrity standards-Maintained documentation, audit trails, and compliance records in accordance with company SOPs and regulatory requirements-Provided training and demos to end-users, ensuring proper use of validated system features and adherence to operational protocols-Supported client audits and regulatory inspections by providing validation evidence, test reports, and system documentation.

Education

• University of Kerala

  Master's degree

  2013 — 2015

• University of Kerala

  Bsc chemistry

  2010 — 2013

Skills

• Pharmaceutical Industry
• Validation
• Gmp
• Standard Operating Procedure (Sop)