Computer Validation Specialist

Morristown, New Jersey | contract

Post Date: 12/07/2017 Job ID: 15490
Computer Validation Specialist
Morristown, NJ

Our client in Morristown, NJ has a contract opening for a Computer Validation Specialist.

RESPONSIBILITIES 
  • Lead planning, creation, review, and execution of GxP documentation deliverables (plans, protocols, tests, reports, etc.). 
  • Ensure GxP document deliverables are in compliance with Site and Corporate policies and procedures following a Risk-based Lifecycle Approach from URS development through system retirement. 
  • Maintain System Validation, Data Integrity, CFR 21 Part 11 Compliance, in Change Management Process 
  • Work closely with business stakeholders, technical support groups, and QA to thoroughly investigate validation discrepancies and drive best-practice for systems validation; 
REQUIREMENTS
  • Bachelor's Degree in Computer Science, Life or Physical Sciences, or related discipline. 
  • 5-10 years of experience in a GXP environment or validation of IT applications, or an equivalent combination of education and experience. 
  • Knowledge of GXP and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and Change Management Processes 
  • Experience in the implementation and validation of stand-alone IT applications as well as complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems. 
  • Technical proficiency, attention to detail, creativity, innovation, and independent thought. 

Computer Validation Specialist - 15490

Kathryn Duran

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