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Computer Systems Validation (CSV)

Company: Genesis AEC
Location: Durham
Posted on: February 25, 2021

Job Description:

What You Will Do:Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to:* Computer Validation Plans* Risk Assessments* Design Qualifications* Traceability Matrix* User/Functional Requirement/Design/Configuration Specifications* Test Protocols (IQ/OQ/PQ), and Summary Reports for Computer Systems* Change Controls* Compliance ReviewsOversee testing and validation activities and assure quality of documentation.Data Integrity experience is a must.Experience in GAMP.Experience with GMP Equipment (e.g. autoclaves, packaging equipment, form/fill equipment)Experience with Rockwell, Honeywell and their associated platforms, MES, Delta V, PI, etc.Powered by JazzHRZ0KFtkRy1g

Keywords: Genesis AEC, Durham , Computer Systems Validation (CSV), IT / Software / Systems , Durham, North Carolina

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