Urgent Requirement- Computer System Validation || Contract || Raritan, NJ (Hybrid) || HCL

June 12, 2023

Urgent Requirement- Computer System Validation || Contract || Raritan, NJ (Hybrid) || HCL

I hope you are doing well.

I have an urgent position for a Computer System Validation role. If interested, please share your resume at abhay@intellectt.com and call me at +1-7323557412.

Location – Hybrid Mode in Raritan, NJ

Required, 10 years’ experience in CSV.

Must have skills - CSV, GxP, 21 CFR part 11, JIRA, X-RAY

JD (Detailed)	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.
Designation	Manager
City & Country	Raritan, NJ, USA (3 Days onsite in a week)
Remote	No