CSV Consultant

Katalyst Talent Agency
Fayetteville, AR, United States
about 2 months ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Experienced
Experience required
2 years minimum
Compensation
$48,000.0 - $58,000.0
Working hours
Regular working hours

Tech stack

Systems Development Life Cycle System Testing GXP

Requirements

  • 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.

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