Sr Quality Engineer, Computerized Systems
Must Have:
•7 years Computer Systems
•Validation
•Compliance - quality oversight
•GMP
•Proficient with Computerized systems onEnterprise 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 includesNew implementation, Enhancements, Quarterly releases, etc.
•Participateand Drive System Assessments, review and approve the project deliverables includingplan, test scripts, execution and its outcome, reports, traceability