Computerized System Validation (CSV) / Computerized System Assurance (CSA)

Role: Computerized System Validation (CSV) / Computerized System Assurance (CSA)

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 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.
• 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.