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Sr Quality Engineer, Computerized Systems

Must Have:

7 years Computer Systems
Validation
Compliance – quality oversight
GMP
Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects
Bachelor’s degree in IT or Computer Science
5+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
Familiarization with ITIL/GAMP5 Validation Lifecycle
21 CFR, EU regulations
Take Quality ownership, participate in cross functional team discussions, provide quality guidance/decisions for the projects that includes New implementation, Enhancements, Quarterly releases, etc.
Participate and Drive System Assessments, review and approve the project deliverables including plan, test scripts, execution and its outcome, reports, traceability

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Sr Quality Engineer, Computerized Systems Quality & Management