Senior SAP S/4HANA Validation Lead - CSV & Compliance

Infosys Consulting; Foster City (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Infosys Consulting seeks a validation professional to lead CSV activities for SAP ECC to S/4HANA transformations and new SAP implementations in a Life Sciences setting. You will ensure regulatory and quality compliance while defining validation frameworks and lifecycle delivery.

Collaboration with Quality, Compliance and SAP teams is essential. You will work across Finance, Supply Chain, Manufacturing, Procurement, Quality Management and MDG modules, contributing to successful, compliant ERP

Qualifications

• Minimum of 3+ years in Life Sciences consulting or industry.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management and quality requirements for IT projects.
• Understanding of regulatory requirements: 21 CFR Part 11, GxP, GAMP 5, SOX IT, Data Integrity.

Responsibilities

• Own and drive CSV activities for SAP ECC to SAP S/4HANA transformations and new SAP implementations.
• Ensure validation activities comply with regulatory and company quality requirements.
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
• Ensure compliance with 21 CFR Part 11, GxP, GAMP 5, Data Integrity and IT controls.
• Create, review, approve, and maintain Validation Plans, URS, FDS, IQ/OQ/PQ, VRs and SOPs.
• Collaborate with client Quality, Compliance, and Validation teams.
• Work with SAP functional/technical teams across FI/CO, SCM, Mfg, Procurement, QM, MDG.

Skills

CSV/validation

S/4 HANA

Regulatory compliance

Quality management

SOX IT

21 CFR Part 11

GxP

GAMP 5

Cloud validation

Risk management

Validation deliverables

JIRA

ServiceNow

Veeva

HPALM

Tools

Solution Manager

CHARM

SAP GRC

DRC

SAP MDG

SAP Rise

Job description

Infosys Consulting seeks a validation professional to lead CSV activities for SAP ECC to S/4HANA transformations and new SAP implementations in a Life Sciences setting. You will ensure regulatory and quality compliance while defining validation frameworks and lifecycle delivery.

Collaboration with Quality, Compliance and SAP teams is essential. You will work across Finance, Supply Chain, Manufacturing, Procurement, Quality Management and MDG modules, contributing to successful, compliant ERP