Computer System Location: Raritan, NJ

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Onsite from day1 || Contract or W2

Position: Computer System Validation – CSV

Location: Raritan, NJ(Hybrid ||Onsite from day1)

Type: Contract or W2

Keywords –Computer System Validation, CSV, GxP, 21 CFR part 11, Risk Based Approach

Job description:

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.