CSV Validation Lead

Remote • Posted 30+ days ago • Updated 24 days ago
Contract W2
12 Months
No Travel Required
Remote
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • csv
  • Lab Vantage
  • LIMS

Summary

Job Title: CSV Lead

Location - Remote

Mandatory Skills - LIMS – Lab Vantage & CSV

Job Summary:

  • Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation 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.
  • Ability to Review Automated Test script 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 30+ days ago
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Vipin Kumar

Recruitment Manager @ Nityo Infotech Corporation
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