SAP Validation Consultant

Emonkglobal; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

eMonkGlobal Bengaluru seeks an experienced IT validation specialist to design and execute IQ/OQ/PQ protocols for LMS platforms, ensuring adherence to GxP and 21 CFR Part 11. The role focuses on pharma/biotech domain validations and strong documentation practices.

You will lead validation efforts, train teams on procedures, and identify process improvements across projects, contributing to compliance readiness and quality assurance.

Qualifications

• 5-6 years of experience in IT systems validation, especially 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.

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

Skills

SAP Validation

GxP & 21 CFR Part 11

IT systems validation

LMS

Communication skills

Education

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

QA/Validation/Regulatory Compliance certifications

Job description

EXP:1-2 Years

Mandatory Requirement: Hands-on experience in SAP Validation is essential.

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