Sr. Computer Systems Validation Analyst

Company : Karwell Technologies

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 5.
• 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 21 CFR part 11 and Annex 11 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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