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Onsite CSV Lead at Raritan, NJ at Raritan, New Jersey, USA
Email: [email protected]
From:

Sumit Kashyap,

HMG America LLC

[email protected]

Reply to:   [email protected]

Title:  CSV Lead

Location: Raritan, NJ Hybrid(2-3 days a week onsite)

Job Description:

Experience - Validating ERP to AWS Data migration process and Validating Data migration project

Experience in the Pharmaceutical, biotechnology, or medical device industry  5+ years experience with System Development Lifecyle 

5+ years experience in Computer System Validation (Based on the role selected)

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

Knowledge of FDA guidances and industry standards (i.e., GAMP)

Experience in writing and executing documentation for all aspects of the validation deliverables like 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 and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

Strong verbal and written communication skills. 

Ability to work as a team player, lead a team or accomplish tasks without supervision. 

Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, 

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Thanks & Regards

Sumit Kashyap

HMG AMERICA LLC

E:  [email protected]

Direct number - 7327905639

Board number - 7327905001, EXT. 117

W: www.hmgamerica.com

Keywords: quality analyst New Jersey
Onsite CSV Lead at Raritan, NJ
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Thu Jul 11 20:50:00 UTC 2024

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Location: Raritan, New Jersey