Computer System Validation Specialist Job at Katalyst HealthCares and Life Sciences, South Plainfield, NJ

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  • Katalyst HealthCares and Life Sciences
  • South Plainfield, NJ

Job Description

Responsibilities:
  • Possess hands-on experience with the Veeva Vault QualityDocs System.
  • Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice.
  • Conduct GxP Risk Assessments on computer applications utilized in regulated environments.
  • Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations.
  • Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans.
  • Provide oversight and training related to validation activities to multi-functional teams.
  • Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities.
  • Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary.
  • Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain.
Requirements:
  • Bachelor's or master's degree in engineering or a related field (equivalent education and work experience may be considered).
  • 7+ years of experience in a Computer System Validation role within the pharmaceutical, biotech, or other regulated industries.
  • Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC) methodologies, IT change management, documentation, verification, and validation techniques.
  • Hands-on experience validating and maintaining the Veeva Vault QualityDocs system and data migration.
  • Understanding of GAMP 5 techniques, software industry standards, and their implications on internal procedures and software quality.
  • Working knowledge of FDA Quality System Regulation, 21 CFR Part 11 and Annex 11 regulations.
Katalyst HealthCares and Life Sciences

Job Tags

Work experience placement,

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