Computer System Validation QA (CSQA)

  • Posted 1 hour ago | Updated 1 hour ago

Overview

Remote
Up to $70
Contract - W2
Contract - 12 Month(s)

Skills

Validation
CSV
QA
Quality Assurance
Veeva
ServiceNow
Jira

Job Details

Mandatory skills
  • IT CSV Validation of IT systems
  • IT QA / QA eCompliance Manager
  • Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM
  • Pharma industry experience is mandatory
  • Medical device experience is good to have
Job description
Maintain Inspectional Readiness
Ensure supported systems are validated
Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
Ensure all Inspection Readiness materials are current and appropriate
Deliver Projects, Programs, and Support
Provide consulting and interpretation on client processes as related to the supported computer system
Provide training to customer areas on CSV-related topics as needed
Partner with Business, Business Quality, and IT customer areas to deliver business value
Understand customer, company, and Quality priorities
Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
Engage customers and QA management in appropriate discussions of risk management
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to the appropriate persons
Strive for and promote consistency within the CSQA Organization
Streamline and Continuously Improve
Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality
Identify opportunity for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for the supported IT area(s)
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