Lead SAP S/4HANA Validation Consultant

Infosys; Foster City (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Infosys in Foster City, CA is seeking a Principal Consultant – SAP S/4HANA Validation Lead for Life Sciences. The role focuses on computerized system validation for ERP like ECC/SAP S/4HANA, cloud validation, risk management and quality management.

You will drive validation activities during SAP transformations and implementations. Key responsibilities include developing validation strategies, ensuring regulatory compliance, managing validation deliverables and partnering with Quality &

Qualifications

• Lead CSV activities for SAP ECC to SAP S/4HANA transformations and new SAP implementations.
• Develop and execute validation strategies, plans, protocols and reports for GxP and non-GxP systems.
• Ensure validation activities comply with regulatory and quality requirements.
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
• Conduct system risk assessments and determine validation scope.
• Implement risk-based testing aligned with GAMP 5 and industry best practices.
• Ensure compliance with 21 CFR Part 11, GxP, GAMP 5, Data Integrity, Data Privacy, Information Security, and SOX IT controls.
• Support audit readiness and inspection preparedness.
• Create, review, approve, and maintain Validation Plans, URS, FDS, IQ/OQ/PQ, TRMs, VSRs and SOPs.
• Collaborate with client Quality, Compliance and Validation teams.
• Recommend process improvements and updates to CSV procedures and SOPs.
• Work with SAP functional/technical teams across FI/CO, SCM, QM, MDG.

Responsibilities

• Develop Validation Strategy & Risk-Based Approach.
• Ensure Regulatory Compliance.
• Manage Validation Deliverables.
• Partner with Quality & Compliance Teams.
• Support SAP Implementation Workstreams.

Skills

CSV Leadership

SAP S/4HANA Validation

Validation Strategy

Regulatory Compliance

Risk-Based Testing

GxP Compliance

21 CFR Part 11

SDLC Validation

SAP Tools

Project Leadership

Lean/Agile

Audit Readiness

Collaboration

Tools

Solution Manager

CHARM

SAP GRC

Data Migration Tool SNP

Job description

Infosys in Foster City, CA is seeking a Principal Consultant – SAP S/4HANA Validation Lead for Life Sciences. The role focuses on computerized system validation for ERP like ECC/SAP S/4HANA, cloud validation, risk management and quality management.

You will drive validation activities during SAP transformations and implementations. Key responsibilities include developing validation strategies, ensuring regulatory compliance, managing validation deliverables and partnering with Quality &