Computer System Validation Job at eTeam, Inc., Raritan, NJ

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  • eTeam, Inc.
  • Raritan, NJ

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

Job Tags

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