What are the responsibilities and job description for the Sr Quality Engineer, Computerized Systems Quality & Management position at Gardner Resources Consulting, LLC?
Sr Quality Engineer, Computerized Systems
Must Have :
- 7 years Computer Systems
- Validation
- Compliance – quality oversight
- 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
