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Hiring : Computer System Validation : Raritan, NJ (Hybrid) at Raritan, New Jersey, USA
Email: [email protected]
From:

Sumit Kumar,

Tanisha Systems Inc

[email protected]

Reply to:   [email protected]

Greetings,

My name is Sumit, and I am Delivery Manager at. Tanisha Systems Inc is a global contingency staffing firm servicing. We have an excellent job opportunity with one of our clients.

Title: Computer System Validation

Location: Raritan, NJ (Hybrid)

Type: Contract

Job Description:

             In addition to validation and regulation experience, the resource should have the following experience.

             3 to 7 years Experience in the Validating IT software systems like Quality Management System in Life Sciences industry

             Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.

             Experience in validating Global Risk and Compliance modules

             Provides consultation and counselling on Risk and Compliance module implementation in reference to regulatory quality

             Knowledge of FDA guidances and industry standards

             Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)

             Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process

             Hands-on experience in software life-cycle management in System data archival process

             Ability to provide Validation guidance, timely reviews, and escalations to Project teams.

Skills

             CSV, Computer System Validation, Tools validation,  Quality Management System, 21 CFR 820, ISO 13485

Sumit kumar

Delivery Manager, Tanisha Systems Inc

Phone

: 

212-729-6543 Ext |

Email

:  

[email protected]

 | 

Address

: 
99 Wood Ave South Suite # 308,Iselin, NJ 08830

Linkedin:
https://www.linkedin.com/in/sumit-kumar-6aa1aa20b/

Keywords: access management information technology New Jersey
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Wed Dec 13 10:53:00 UTC 2023

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Location: Raritan, New Jersey