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Validation Lead- Raritan, NJ(Hybrid)

RapidIT, Inc

Hybrid in Raritan, New Jersey • Today

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Role - Validation Lead

Location -Raritan, NJ(Hybrid)

Job Details:

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.

Experience in the Pharmaceutical, biotechnology, or medical device industry

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

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, System/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, timely reviews, and escalations to TQ management

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: 10118140
Position Id: 9047883
Posted 19 hours ago

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Praveen Boddam

RapidIT, Inc Recruiter @ RapidIT, Inc

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Job Details

Skills

Summary

Role - Validation Lead

Location -Raritan, NJ(Hybrid)

Job Details:

Experience in the Pharmaceutical, biotechnology, or medical device industry

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

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, System/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, timely reviews, and escalations to TQ management

Dice Id: 10118140
Position Id: 9047883
Posted 19 hours ago

Fitment

Dice Job Match Score™

🧠 Analyzing your skills...

Contact the job poster

Praveen Boddam

RapidIT, Inc Recruiter @ RapidIT, Inc

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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