3+ years in Life Sciences consulting or pharmaceutical environments
Proven experience in creating and approving validation and compliance deliverables
Strong grasp of quality management systems and risk management
In-depth knowledge of pharmaceutical compliance regulations (21 CFR Part 11, GxP, GAMP 5)
Experience with SAP transformation programs and ERP implementations
Familiarity with validation and testing tools (HP ALM, SAP Solution Manager, JIRA)
Hands-on experience with SAP data migration tools and frameworks
Responsibilities
Lead compliance and validation for SAP ECC to SAP S/4HANA transformations
Oversee ERP testing activities including planning and execution governance
Ensure adherence to regulations and industry standards
Establish validation frameworks for SAP transformation and data migration
Create and maintain validation deliverables like Validation Plans and Test Protocols
Manage compliance for SAP Data Migration programs
Support audit readiness by presenting compliance evidence and documentation
Benefits
Collaborative work environment with cross-functional teams
Opportunity to work on large-scale SAP implementation initiatives
Engagement in high-impact projects within regulated Life Sciences
Professional development and training opportunities
Exposure to diverse SAP modules and technologies
Full Job Description
Job Description
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/4HANA transformation programs and large-scale SAP implementation initiatives, with a strong focus on test governance, data migration controls, compliance oversight, and audit readiness. Key Responsibilities
Lead compliance and validation activities for SAP ECC to SAP S/4HANA 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 workstreams.
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)
Basic Skills & Experience
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
ServiceNow
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.
Required Skills & Experience
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 migration control frameworks.
Excellent understanding of Data Migration deliverables including DCMP/R, DMWs, DORs, DMLs, DVTs, reconciliation reports, and defect management processes.
Experience supporting internal audits, regulatory inspections, and audit readiness activities.
Familiarity with Agile and Waterfall delivery methodologies.
Ability to support multiple projects simultaneously in complex global environments.
IT consulting, Big 4, or major technology services experience preferred.
Excellent communication, stakeholder management, and collaboration skills.
Estimated annual compensation will be $92,840 CAD to $123,470 CAD
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