Job Summary

An SAP Validation Analyst is responsible for ensuring SAP applications and related business processes meet Computer System Validation (CSV), GxP, data integrity, and regulatory compliance requirements, particularly in pharmaceutical, biotechnology, and medical-device environments. The role supports SAP implementations, upgrades, enhancements, and change controls through risk-based validation, testing, and documentation

Key Responsibilities

Perform SAP system validation for implementations, upgrades, configuration changes, and enhancements.Prepare/review validation documentation such as Validation Plans, URS, Functional/Design Specifications, IQ/OQ/PQ, Traceability Matrix, test protocols, and validation reports. Develop and execute test scenarios/scripts and document evidence and results.Perform risk assessments, deviation management, root-cause analysis, and support corrective actions.Ensure compliance with GxP, FDA requirements, 21 CFR Part 11, and applicable company quality procedures Support change control and validation activities throughout the SAP system lifecycle.Collaborate with SAP functional teams, technical teams, QA,



business stakeholders, and external vendors.Support regulatory audits and inspections by providing validation documentation and evidence

Skill Requirements

Core skills:
SAP Validation / Computer System Validation (CSV)
GxP compliance
Validation lifecycle documentation
IQ/OQ/PQ
URS and functional/design specifications
Test planning, test execution, and defect management
Requirements Traceability Matrix
Risk assessment and change control
Data integrity and regulatory compliance
Knowledge of 21 CFR Part 11 / GAMP 5 principles
Understanding of SAP business processes and relevant SAP modules
Robust documentation, analytical, and stakeholder-management skills

Preferred profile: Experience working on SAP systems in a pharmaceutical, life-sciences, biotechnology, or medical-device regulated setting is particularly relevant

Must Have Skill

Computer System Validation (CSV),Life-Sciences (GxP/FDA/CSV/IQ/OQ/PQ),SAP S4HANA

Valuable to Have Skill

Other Requirements

📌 Business Specialist Chennai
🏢 HCLTech
📍 Chennai