Computer System Validation Analyst

Summary :

• Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
• 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.

Roles & Responsibilities :