Computer Systems Validation

18 May 2024

Vacancy expired!

Position: CSV Specialist

Job SummaryThe Computer System Validation Specialist is an individual with knowledge of GxP compliance as it applies to Computer Systems, 21 CFR Part 11, GAMP 5, Business Analysis and Computer System Validation, and documentation review for FDA and GxP compliance issues.

Responsibilities include:
  • Provide CSV Support for IT and Engineering Projects.
  • Ensure that proper Computer Systems Validation procedures are followed during system implementations
  • Creation and/or Review Computer Systems Validation documents for various projects.
  • Work with vendor provided CSV documents for review and routing for approval
  • Work with project managers/SMEs/IT Leads to collaborate on User and functional requirements for systems.
  • Routing/Tracking CSV Documents for approval.
  • Monitor the status of documents out for approval and inform project managers when their documents are approved
  • Oversee Test executions, Review Executed protocols, write up protocol deviations and prepare documentation sets for approvals.
  • Provide training for Test Execution methodology to testers prior to test execution.
  • Maintain CSV Documentation.
  • Manage IT Change Control process
  • Perform/Track Periodic Review/Compliance Monitoring of validated systems.

Skills:
  • Knowledge of GxP Compliance with respect to Computer Systems
  • Knowledge of 21CFR Part 11 and GAMP 5
  • MS Office suite
  • Good time management skills and the ability to multitask and complete tasks in a timely manner.
  • Analytical skills & ability to pick up requirements, workflows and system navigation for IT applications.

  • ID: #41102488
  • State: New York Monsey 10952 Monsey USA
  • City: Monsey
  • Salary: Depends on Experience
  • Job type: Permanent
  • Showed: 2022-05-18
  • Deadline: 2022-07-16
  • Category: Et cetera