What are the responsibilities and job description for the Computer System Validation position at Incorporan Inc?
Job Description
Role : Computer System Validation
Location : Hybrid Mode in Raritan, NJ
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.
LL01-030524 Project Manager for CQV Documentation Project
Validation & Engineering Group -
Raritan, NJ
Validation Engineer
Rangam -
Warren, NJ
Validation Engineer
Synectics Inc. -
Warren, NJ