Computerized System Validation (CSV) / Computerized System Assurance (CSA)
- Toronto, ON, Canada
- Greater Toronto Area, Canada, Canada
Contract
Applications open in a new tab.
Job details
- Job type
- Contract
- Apply by
- Experience
- 5 – 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
- Posting language
- English
- Posted
Original job description
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.
More about this job
Responsibilities
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.
Skills
- Computerized System Validation
- Computerized System Assurance
- SAP Validation
- Data Migration
- Risk Management
- Test Management
- Audit Management
- Pharmaceutical Compliance
- Validation Deliverables
- Risk-Based Testing
- Requirements Traceability
- Defect Lifecycle Management
- Quality Assurance
- Stakeholder Management
- Communication and Presentation
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Technology
- Consulting
- Manufacturing
Keywords
- Computerized System Validation
- Computerized System Assurance
- Life Sciences
- Pharmaceutical Manufacturing
- SAP
- Data Migration
- 21 CFR Part 11
- GxP
- GAMP 5
- Risk-Based Testing
- Requirements Traceability
- Defect Lifecycle Management
- Quality Assurance
- Risk Management
- Test Management
- Audits
- Validation Deliverables
- Change Management
- Deviation Management
- Supplier Management
- HP ALM
- Documentum
- Veeva
- ServiceNow
- Stakeholder Management