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Urgent role of CSV Consultant :: Raritan, NJ (Hybrid) at Raritan, New Jersey, USA
Email: [email protected]
From:

Akshat,

Tanishasystems.inc

[email protected]

Reply to:   [email protected]

Greetings..!!

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

DO NOT SHARE ANY CPT,OPT,GC, GCEAD, USC CANDIDATES.

Title:
CSV Consultant

Location: Raritan, NJ (Hybrid

)

Type:
Contract(W2 and C2C)

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.

Mandatory Skills

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

Regards

Akshat Kumar

E: - 212 729 6543 EXT 688  

[email protected]

www.tanishasystems.com

linkedin.com/in/akshat-kumar-7245821a2

99 Wood Ave South,
Suite # 308, Iselin,

New Jersey, NJ 08830
, USA

Keywords: access management information technology green card wtwo New Jersey
[email protected]
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Wed Dec 13 18:35:00 UTC 2023

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Location: Raritan, New Jersey