Job Description
Keywords Computer System Validation, CSV, GxP, 21 CFR part 11, Risk Based Approach Roles and Responsibilities - 10+ yrs. of experience in Computer System Validation
- Senior Level individual with GxP experience
- Ability to lead, fully knowledgeable of Agile based System development process
- Exhibits strong knowledge and hands-on experience in Agile concepts and applies AGILE approach in using tools like JIRA, X-ray/qTest
- Handles and maintains projects in JIRA along with burn charts, manage time and backlog
- Fully knowledgeable of the Regulated Quality Processes (GxP assessment, CSV Assessment)., etc. and application of Risk Based Approach in system development and change management process
- Review and approves applicable project related artifacts to ensure regulatory quality
- Adept in handling Change Management of Computerized systems
Efficient in Quality Management related to GxP regulations
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