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Urgent Opening for CSV Consultant -----------------------------|| Raritan, NJ || ---------------------- || Day 1 Onsite || at Raritan, New Jersey, USA
Email: [email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=931276&uid=

Hi,

I hope you are doing well.

I have urgent position of CSV Consultant. If you are available for this role. Please let me know and Please Share your updated resume at
[email protected]

Role : CSV Consultant

Location : Raritan, NJ

Contract : Long Term

Job description:

Job Title/Role

CSV Consultant

Mandatory Skills

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

Yes

Job Description

Roles and Responsibilities

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 counseling 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.

Thanks & Regards,

Pragyesh Kumar

517 Route 1 S Suite 1115,Iselin, NJ 08830

Intellectt Inc.

https://www.intellectt.com/

E-mail:
[email protected]

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Keywords: information technology wtwo New Jersey
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10:20 PM 12-Dec-23


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Location: Raritan, New Jersey