We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation/Computerized System Assurance, Risk Management, Test Management and Audits.

Below are the role expectations:

- 5 – 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
- Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
- Experience creating, reviewing, and approving / acknowledging validation deliverables.
- Robust knowledge of Software Development Life Cycle (SDLC), testing methodologies, risk-based testing, requirement traceability, defect lifecycle management, and quality assurance processes,



with the ability to analyze business and functional requirements and identify quality risks.
- Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements.
- Experience with validation of SAP system and data migration projects is mandatory
- Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)
- Knowledge of validation tools and templates used in the pharmaceutical industry. Example: HP ALM, Documentum, Veeva and ServiceNow.

📌 SAP Validation SME- IT CSV (Toronto)
🏢 Burgeon IT Services
📍 Toronto