Consultant- SAP CSV & Data Migration, Life Sciences- Business Consulting

Consultant- SAP CSV & Data Migration, Life Sciences
- Business Consulting

Domain

Consulting

Interest Group

Company

ITL Canada

Requisition

154297

Consultant- SAP CSV & Data Migration, Life Sciences
- Business Consulting

We are seeking experienced professionals with proven success in Computer System Validation (CSV), ERP Testing, Data Migration Compliance, and Quality Management within regulated Life Sciences environments. The ideal candidate will support SAP ECC to SAP S/4

HANA transformation programs and large-scale SAP implementation initiatives, with a strong focus on test governance, data migration controls, compliance oversight, and audit readiness.

• Lead compliance and validation activities for SAP ECC to SAP S/4
  
  HANA transformation and SAP implementation programs.
• Provide oversight for ERP testing activities, including test planning, test script reviews, test execution governance, defect management, and traceability.
• Ensure compliance with applicable regulations and industry standards, including 21 CFR Part 11, GxP, GAMP 5, Data Integrity, Information Security, and Data Privacy requirements.
• Establish and execute validation and compliance frameworks for SAP transformation and data migration work streams.
• Create, review, approve, and maintain validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, Validation Summary Reports, Test Protocols, and Quality Documentation.
• Manage compliance activities associated with SAP Data Migration programs and ensure alignment with quality and regulatory expectations.
• Review and assess Data Migration deliverables, including:
  • DCMP/R (Data Compliance Management Plan/Report)
  • DMWs (Data Migration Workbooks)
  • DORs (Data Owner Reviews)
  • DMLs (Data Migration Logs)
  • DVTs (Data Verification Testing)
  • Defect and Reconciliation Reports
• Partner with Quality, Compliance, Validation, Business, and IT teams to ensure migration activities remain in a validated state throughout the project lifecycle.
• Support audit and inspection readiness activities, including presentation of data migration controls, compliance evidence, validation documentation, and testing records.
• Collaborate with SAP functional and technical teams across modules such as:
• Finance (FI/CO)
• Supply Chain
• Manufacturing
• Procurement
• Quality Management (QM)
• Master Data Governance (MDG)

• Minimum 3+ years of professional experience in Life Sciences consulting and/or pharmaceutical industry environments.
• Experience creating, reviewing, and approving validation and compliance deliverables.
• Strong understanding of quality management systems and risk management processes.
• Solid understanding of pharmaceutical compliance regulations including:
  • 21 CFR Part 11
  • GxP
  • GAMP 5
  • Data Integrity
  • Data Privacy
  • Information Security
  • SOX IT Controls
• Experience supporting SAP transformation programs, ERP implementations, or large-scale system migrations.
• Knowledge of SAP implementation methodologies and core business processes.
• Experience using validation and testing tools such as:
  • HP ALM / Micro Focus ALM
  • SAP Solution Manager
  • SAP CHARM
  • JIRA
  • Service Now
• Experience with SAP data migration tools and frameworks, including SNP, ADM, Migration Cockpit, or equivalent tools.
• Candidates authorized to work for any employer in Canada without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration.

• Strong understanding of compliance, validation, and quality concepts within regulated Life Sciences environments.
• Hands-on experience in ERP test management, including:
  • Test Planning
  • Test Script Review
  • Test Execution Oversight
  • Defect Governance
  • Traceability Management
  • Validation Evidence Review
• Experience supporting SAP Data Migration compliance activities and…