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