We are looking for an experienced CSV (Computer System Validation) Subject Matter Expert to ensure compliance of IT systems in highly regulated environments. You will lead validation efforts for platforms including Learning Management Systems (LMS), ensuring strict adherence to FDA and GxP requirements.

? Note ✅ Experience in IT Systems Validation is mandatory ✅ Hands-on experience with LMS (Learning Management System) validation is a must ? Responsibilities Design and execute validation protocols (IQ/OQ/PQ)

Create test scripts, risk assessments, and reports

Ensure compliance with FDA, GxP, 21 CFR Part 11 Lead validations specifically for LMS platforms Train teams on validation procedures and compliance standards

Identify process improvements and conduct periodic reviews ? Requirements 5–6 years of experience in IT systems validation , especially in LMS

Strong understanding of GxP and 21 CFR Part 11 Experience In Pharma, Biotech, Or Medical Device Domains Proficient in validation documentation and tools

Cooperative Team Player With Excellent Communication Skills ? Education Bachelor’s in Life Sciences, Engineering, Pharmacy, or Computer Science Certifications in QA, Validation, or Regulatory Compliance are a plus

📌 CSV SME (Bengaluru)
🏢 eMonkGlobal
📍 Bengaluru