Principal SAP Computerized System Validation (CSV) – Life Sciences Consulting

About the role

Infosys is seeking a Principal consultant to lead Computerized System Validation (CSV) for SAP applications within life‑sciences business consulting. The role will guide validation activities for SAP ECC to S/4HANA transformations and new implementations, ensuring compliance with GxP, regulatory and quality standards.

Key responsibilities

• Own and drive CSV activities for SAP ECC to S/4HANA transformation programs and new SAP implementations.
• Develop and execute validation strategies, plans, protocols and reports for GxP and non‑GxP systems.
• Define risk‑based validation frameworks, conduct system risk assessments and align testing with GAMP 5 best practices.
• Ensure compliance with 21 CFR Part 11, GxP regulations, data integrity, data privacy, information security standards and SOX IT controls.
• Create and maintain validation deliverables such as Validation Plans, URS, Functional & Design Specifications, IQ/OQ/PQ documents, traceability matrices and Validation Summary Reports.
• Collaborate with client Quality, Compliance and Validation teams to support audit readiness and recommend process improvements.
• Work closely with SAP functional and technical teams across Finance, Supply Chain, Manufacturing, Procurement, Quality Management and Master Data Governance to assess validation impact.

Required profile

• Proven success in Computerized System Validation for ERP applications, especially SAP ECC and SAP S/4HANA.
• Experience delivering validation services in life‑sciences or regulated environments.
• Strong understanding of GxP, GAMP 5, risk‑based testing and regulatory compliance.
• Ability to lead cross‑functional teams and communicate with quality and compliance stakeholders.

Required skills

• SAP ECC
• SAP S/4HANA
• GAMP 5
• 21 CFR Part 11
• SOX IT controls
• Data integrity and data privacy
• Information security standards
• Risk assessment and risk‑based testing