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Katalyst HealthCares & Life Sciences
Sr. Computer Systems Validation AnalystKatalyst HealthCares & Life Sciences • Foster City, CA
Sr. Computer Systems Validation Analyst

Sr. Computer Systems Validation Analyst

Katalyst HealthCares & Life Sciences • Foster City, CA
30+ days ago
Job type
  • Full-time
Job description

Roles & Responsibilities:
  • Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
  • Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
  • Author documents related to GxP Systems
  • Draft Requirements and computer systems validation documents using GAMP
  • Execute test protocols for the software validation.
  • Initiate and execute change management for existing qualified systems.
  • Develop change management record, create or revise documentation if required, and execute implementation tasks.
  • Use understanding of CFR part and Annex and how these regulations relate to a process control system
  • Maintaining the project plan/schedule to meet deliverable commitments.
Education & Experience:
  • User and Configuration Specifications
  • System Impact Assessments
  • Risk Assessments
  • Installation Qualification Protocols
  • Operation Qualification Protocols
  • Performance Qualification Protocols
  • Traceability Matrix
  • Summary Reports Standard Operating Procedures
  • Authoring Change Controls
  • Authoring and executing test protocols
  • Managing Issue Reporting, Deviations and related CAPAs

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Sr. Computer Systems Validation Analyst • Foster City, CA

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