CSV Engineer

3 weeks ago

Bridgewater, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • 7+ years of experience in Computer System Validation
  • Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams
  • Responsible for the review and approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use
  • ttending Project Team meetings and provide CSV compliance guidance and support to project and base business support team members
  • Review and approval of infrastructure qualification deliverables IQ/OQ/Change Control Major Duties and Responsibilities In order of importance, briefly describe, in sentence form, the essential functions/major responsibilities of this position (principal duties and responsibilities of the position) as it exists today.
  • Lead/support validation efforts and deliverables for projects requiring validation as required to support for global migration efforts for ERP systems.
  • Maintain and Report the project related Metrics
  • Perform pre and post review and approval of validation test scripts including test defects, for support of go-live during hours of support which may include working on nights and weekends to support project needs.
  • uthor, review, and/or approve of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
Requirements:
  • Perform CSV review and approval of Computerized System change controls including final release approval for production use
  • Ensure a high degree of Inspection Readiness for Systems in TQ portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within TQ responsibility
  • Participate in audits, approves audit non-conformity action plans and approve closure of internal audit findings
  • Demonstrates an understanding of many relevant Quality and Compliance areas and their applications
  • Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
  • Facilitate education and training to the organization on CSV program procedures and controls
  • Work with various SMEs to obtain needed information to complete above deliverables; Leads testing efforts by managing pre/post approvals and associated discrepancies
  • Works collaboratively with project teams to keep them informed of project status, including any barriers
  • Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
  • Utilizes knowledge of relevant Quality and Compliance principles to recommend existing solutions to organization s needs

  • CSV Engineer

    2 days ago

    Bridgewater, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: 7+ years of experience in Computer System Validation Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams...