CSV SME

eMonkGlobal; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

eMonkGlobal is seeking an experienced CSV (Computer System Validation) Subject Matter Expert based in Bengaluru, India. The candidate will lead validation efforts for IT systems, particularly Learning Management Systems (LMS), ensuring compliance with FDA and GxP standards. Required skills include extensive experience in IT validation and a strong understanding of regulatory requirements. The role involves designing protocols, training teams, and executing validations. Ideal candidates possess relevant educational backgrounds and communication skills.

Qualifications

• 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.

Responsibilities

• Design and execute validation protocols (IQ/OQ/PQ).
• Create test scripts, risk assessments, and reports.
• Ensure compliance with FDA, GxP, and 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.

Skills

IT systems validation

GxP understanding

Collaboration

Communication skills

Education

Bachelor’s in Life Sciences, Engineering, Pharmacy, or Computer Science

Certifications in QA, Validation, or Regulatory Compliance

Job description

Overview

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.

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
• Collaborative 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