CSV Validation Lead

Hybrid in Raritan, NJ, US • Posted 10 hours ago • Updated 10 hours ago
Contract W2
12 Months
50% Travel Required
Hybrid
Depends on Experience
Fitment

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Job Details

Skills

  • csv
  • Computer System Validation
  • Annex

Summary

Role CSV 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: 10200946b
  • Position Id: 9055670
  • Posted 10 hours ago
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Vipin Kumar

Recruitment Manager @ Nityo Infotech Corporation
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