Sr. Computer Systems Validation Analyst

Roles & Responsibilities :

• Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLCs 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 :

Katalyst HealthCares & Life Sciences

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