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CSV Consultant

Hybrid in Raritan, NJ, US • Posted 9 hours ago • Updated 9 hours ago

Contract W2

Contract Corp To Corp

Contract Independent

No Travel Required

Hybrid

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

FDA
GxP
GAMP
biotechnology
Lifecyle

Summary

Ex-J&J preferred
Experience in the Pharmaceutical, biotechnology, or medical device industry
2+ years’ experience with System Development Lifecyle
3+ 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 guidance’s and industry standards (i.e., GAMP)
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 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91098872
Position Id: 5258-10115-
Posted 9 hours ago

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