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

Job summary

Create, review, and approve or acknowledge validation deliverables for computerized systems, including SAP validation and data migration projects. Apply risk management, test management, audit, and quality assurance practices to help ensure IT projects meet pharmaceutical quality and regulatory requirements.

Job details

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.

What you’ll do

Create, review, and approve or acknowledge validation deliverables for computerized systems, including SAP validation and data migration projects. Apply risk management, test management, audit, and quality assurance practices to help ensure IT projects meet pharmaceutical quality and regulatory requirements.

Requirements

Requires 5–10 years of Life Sciences industry experience and strong communication and presentation skills, with mandatory SAP validation and data migration experience. Candidates should understand 21 CFR Part 11, GxP, GAMP 5, SDLC, risk-based testing, traceability, defect management, and pharmaceutical validation tools and processes.

Listed skills

• Risk Management · Preferred
• Quality assurance · Preferred
• Stakeholder Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Computerized System Validation
• Computerized System Assurance
• SAP Validation
• Data Migration
• Risk Management
• Test Management
• Audit Management
• Pharmaceutical Compliance
• Validation Deliverables
• Software Development Life Cycle
• Risk-Based Testing
• Requirements Traceability
• Defect Lifecycle Management
• Quality Assurance
• Stakeholder Management
• Communication and Presentation

Job areas

• Healthcare
• Technology
• Consulting
• Manufacturing

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