Sr. Computer Systems Validation Analyst

Katalyst Healthcares and Life Sciences

Foster, CA

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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Vacancy posted 4 days ago

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