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QA Computer System Validation Supervisor

Company: Expedite Technology Solutions
Location: Alpharetta
Posted on: March 15, 2023

Job Description:

Job Title: QA Computer System Validation Supervisor
Location: -12380 Morris Road Alpharetta GA 30005 United States
Duration: 12 Months Contract with Extension
Shift Hours: 8 AM- 5 PM
Payrate: $ 50.00/ hr on W2.

Job Duties

  • Writes, executes, and reviews validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for SCS in validation matters
  • Reviews policies, procedures, and regulations with internal/external clients to determine specialized requirements and ensure compliance
  • Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards
  • Leads validation personnel or projects, when assigned
  • Records information and observations from internal audits to support the preparation and distribution of internal audit reports
  • Establishes and maintains quality policies and programs within the IT area to ensure proper document and data control methods are utilized
  • Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities
  • Interacts with internal auditors to discuss audit plans and findings
  • Ensures continued learning of new/existing regulatory requirements by the various regulatory bodies governing our healthcare industries
  • Participates in consultations with Corporate Legal to determine compliance implications of pending business
  • Ensures consistent and timely completion of compliance-base tasks as assigned including but not limited to NCs, CAPAs, Audit findings and Document Changes/Management
  • Follows up with clients after audits to identify issues and mutually acceptable solutions

    Minimum Requirements

    • Bachelor's Degree (or internationally comparable degree) in Computer Science, Information Systems or related field - Preferred
    • Possesses knowledge of Supply Chain logistics
    • Experience in the Healthcare industry
    • Minimum of 3 years' computer system validation in a pharmaceutical/medical devices environment, including thorough knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies

Keywords: Expedite Technology Solutions, Alpharetta , QA Computer System Validation Supervisor, IT / Software / Systems , Alpharetta, Georgia

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