Computer System Validation Analyst
Foster City, CA, United States
Job Description
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 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.
- 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
Skills Required
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Job Detail
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Job IdJD6367898
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationFoster City, CA, United States
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EducationNot mentioned