Computer System Validation QA (CSQA)

Computer System Validation QA (CSQA)

Posted Today by 1758268301

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Negotiable
Outside
Remote
USA
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Computer Systems Computer System Validation JIRA Management Market Trend Risk Management ServiceNow SIPOC Process Verification And Validation

Summary: The Computer System Validation QA (CSQA) role focuses on ensuring the validation of IT systems within the pharmaceutical industry, maintaining inspection readiness, and delivering quality assurance through various consulting and training activities. The position requires collaboration with business and IT areas to uphold quality standards and streamline processes. Candidates should have experience with relevant tools and a strong background in the pharma sector. Medical device experience is considered a beneficial addition.

Key Responsibilities:

  • Maintain Inspectional Readiness
  • Ensure supported systems are validated
  • Track quality actions and commitments in Quality/CAPA plans
  • Participate in self-inspections, audits, and supplier assessments
  • Ensure all Inspection Readiness materials are current
  • Provide consulting on client processes related to supported computer systems
  • Deliver training on CSV-related topics as needed
  • Partner with Business, Business Quality, and IT to deliver business value
  • Review/approve documents per CSV expectations
  • Engage customers and QA management in risk management discussions
  • Ensure suppliers meet quality expectations
  • Escalate computer system quality issues as necessary
  • Promote consistency within the CSQA Organization
  • Eliminate non-value-added activities to improve quality assurance
  • Identify opportunities for streamlining and simplification
  • Understand external trends affecting supported IT areas

Key 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
  • Medical device experience (good to have)

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:
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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