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GCP - Computer System Validation Specialist (12 month limited-term)

3 days, 14 hours ago
Canada
Contract
Mid Level
Manual QA Tester
Quality Assurance and Testing
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
501-1000
Founded 1986
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Description

  • Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulations.
  • Develop and maintain validation plans, test scripts, traceability matrices, summary reports, and release documentation.
  • Partner with IT, Quality Assurance, business stakeholders, and vendors to define validation strategies and deliver compliant solutions.
  • Coordinate validation testing and ensure requirements are fully tested and documented.
  • Manage testing defects, deviations, and incidents through triage, resolution tracking, and closure documentation.
  • Facilitate the review, approval, execution, and post-execution management of validation and qualification documentation.
  • Train and support project teams on validation procedures, tools, documentation standards, and best practices.
  • Provide guidance on change management for validated systems and monitor evolving regulatory requirements and industry standards.

Requirements

  • Bachelor’s degree in Computer Science, Information Technology, Engineering, Software Development, or a related field, with 3–5 years of relevant experience; an equivalent combination of education and experience will be considered.
  • Experience validating GCP-regulated computerized systems and software.
  • Experience in pharmaceutical, biotechnology, medical device, or another highly regulated industry is preferred.
  • Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness.
  • Experience working within Software Development Lifecycle (SDLC) processes.
  • Ability to collaborate effectively across cross-functional and matrixed teams, including internal stakeholders, business partners, and external vendors.
  • Excellent written and verbal communication skills for documenting and explaining technical and compliance information.
  • Familiarity with automated testing tools and enterprise validation technologies is an asset.

Benefits

  • Education reimbursement for full-time employees.
  • Monthly cell phone and remote-work allowance, based on role eligibility.
  • One-time home-office setup allowance.
  • Working While Visiting program for up to four weeks per year.
  • Flexible summer hours from May through September.
  • Employee referral incentive.
  • Eligibility for the Alimentiv Trust after one year of employment, with permanent membership after five years.
  • Optional mentorship, leadership development, social events, and team initiatives.

Interested in this position?

Apply directly on the company website

Apply Now

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