Role: Computerized System Validation (CSV) with SAP Experience
Location: Any nearest Office in Canada [need to support EST time zone]
Duration: Long Term
Domain (Industry): Life Sciences & Pharma
Mandatory skills
Strong communication and presentation skills
SAP validation experience
Data migration experience
Desired skills
Good stakeholder management skills
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 qualified 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.
- Strong 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.
📌 Computerized System Validation (CSV) with SAP Experience (Greater Toronto Area)
🏢 Burgeon IT Services
📍 Greater Toronto Area
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