CSV Validation/ Clinical

Hybrid in Independence Township, NJ, US • Posted 3 hours ago • Updated 3 hours ago
Full Time
No Travel Required
Hybrid
Depends on Experience
Fitment

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Job Details

Skills

  • GxP
  • Quality Assurance
  • Computerized System Validation
  • CSV
  • Clinical
  • GxP Requirements
  • GCP regulations
  • 21 CFR
  • Veeva

Summary

CSV Validation/ Clinical

Introduction:

As a CSV Validation/ Clinical specialist, you will be responsible for defining validation strategies for computerized systems and platforms used in the GxP space. Your role will involve creating validation deliverables, participating in user review meetings, conducting risk assessments, and effectively communicating validation activities to project teams and stakeholders.

Responsibilities:

  • Define validation strategy for computerized systems and platforms in GxP Space
  • Create validation deliverables such as Validation Plan, Test Protocols, and Traceability matrix
  • Participate in user review meetings and discussions with Quality Assurance and Compliance groups
  • Participate/conduct Risk Assessments
  • Develop and maintain policies and procedures
  • Communicate validation activities and deliverables to project teams and stakeholders
  • Participate in internal initiatives around Computer Systems Validation

Requirements:

  • Bachelor or Master''s degree in Lifesciences or Computer Sciences
  • 7-10 years'' experience with Computer Systems Validation
  • Strong knowledge of GxP Requirements, Google Cloud Platform regulations, and 21 CFR part 11 requirements
  • Experience with validation of IT infrastructure systems including R, SAS, etc.
  • Experience with GxP systems validation like ELN, LIMS, QMS, etc.
  • Experience with Veeva Vault Systems
  • Clinical experience is a must
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: 10312854
  • Position Id: 8969935
  • Posted 3 hours ago
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