tanishasystems
Boston, MA
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Job Description :

Job Role: CSV Consultant
Location: Raritan, NJ (Hybrid)
Hire Type & Tenure: 12 months contract
Mandatory Skills: CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485
Job Description:
Roles and Responsibilities:

  • In addition to validation and regulation experience, the resource should have the following experience.
  • 3 to 7 years Experience in the Validating IT software systems like Quality Management System in Life Sciences industry
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.
  • Experience in validating Global Risk and Compliance modules
  • Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality
  • Knowledge of FDA guidance s and industry standards
  • 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 related to System data Archival process
  • Hands-on experience in software life-cycle management in System data archival process
  • Ability to provide Validation guidance, timely reviews, and escalations to Project teams.


Client : Tanisha Systems
             

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