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
- Strong documentation, analytical, and stakeholder-management skills

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

Must Have Skill

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

Good to Have Skill

Other Requirements

📌 Business Specialist (India)
🏢 HCLTech
📍 India