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CSV Specialist at Raritan, New Jersey, USA
Email: [email protected]
From:

Benny Wilson,

W3GLOBAL INC

[email protected]

Reply to:   [email protected]

Hi All,

Greetings from W3Global Inc!!

Job Title : CSV Specialist 

Employment Type : Contract, C2C

Location : Raritan, NJ, US
(Hybrid) (Local candidates only)

Job Description

Must Skills:
CSV, Computer System Validation, Tools validation, Quality Management System,
21 CFR 820, ISO 13485
, Acquisition and mergers

Roles and Responsibilities 

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

Roles and Responsibilities

Minimum 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 guidance's 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

Please let me know your interest and let's keep in touch until we make this happen

Referrals appreciated and welcomed.

Thanks & Regards,

Benny Wilson

Recruiter

E:  [email protected]

A:  
1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

Keywords: information technology New Jersey
[email protected]
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Mon Jan 15 19:17:00 UTC 2024

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Location: Raritan, New Jersey