SAP Validation SME [IT CSV] | Canada Any Location Near by clinet office
- Toronto, ON, Canada
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Original job description
Job Title: SAP Validation SME (IT CSV)
Location: Canada (Hybrid; near any client office)
Duration: 12 months plus
Experience: 5–10 years
Domain: Life Sciences / Pharmaceuticals
Working Hours: EST business hours
Job Description:
We are looking for an experienced SAP Validation SME with strong expertise in Computerized System Validation (CSV) and data migration validation within the pharmaceutical or life sciences industry.
Mandatory Skills:
- 5–10 years of experience in Life Sciences / Pharma.
- Hands-on experience in SAP system validation and data migration validation.
- Strong knowledge of CSV/CSA, GxP, 21 CFR Part 11 and GAMP 5.
- Experience preparing, reviewing and approving validation documents and test deliverables.
- Knowledge of SDLC, risk-based testing, requirements traceability, defect management and QA processes.
- Understanding of risk management, change control, deviation management, supplier management and audit compliance.
- Familiarity with validation tools such as HP ALM, Documentum, Veeva Vault or ServiceNow.
- Excellent communication and presentation skills.
Preferred: Strong stakeholder management skills.
More about this job
Responsibilities
Prepare, review, and approve validation documents and test deliverables for SAP system validation and data migration in a life sciences or pharmaceutical environment. Apply CSV/CSA and GxP practices while supporting risk-based testing, traceability, quality processes, and audit compliance.
Requirements
Requires 5–10 years of life sciences or pharmaceutical experience, with hands-on SAP system validation and data migration validation experience. Candidates should know CSV/CSA, GxP, 21 CFR Part 11, GAMP 5, SDLC, risk and change management, and validation tools; strong communication skills are required, with stakeholder management preferred.
Skills
- SAP System Validation
- Data Migration Validation
- Computerized System Validation
- Computer Software Assurance
- GxP
- 21 CFR Part 11
- GAMP 5
- Validation Documentation
- Test Deliverables
- SDLC
- Risk-Based Testing
- Requirements Traceability
- Defect Management
- Quality Assurance
- Change Control
- Deviation Management
Visa sponsorship
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Categories
- Technology
- Healthcare
- Consulting
Keywords
- SAP
- Computerized System Validation
- Computer Software Assurance
- Data Migration Validation
- Life Sciences
- Pharmaceuticals
- GxP
- 21 CFR Part 11
- GAMP 5
- SDLC
- Risk-Based Testing
- Requirements Traceability
- Defect Management
- Quality Assurance
- Risk Management
- Change Control
- Deviation Management
- Supplier Management
- Audit Compliance
- HP ALM
- Documentum
- Veeva Vault
- ServiceNow
- Stakeholder Management