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Chevy chase, MD, US
$63k+
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client in Maryland has an immediate need for a Validation Analyst for a 1000 hour contract to perm role.
Please forward resumes along with contact information, rate, and location. Our client cannot sponsor so US Citizens,
Green card holders or EAD ONLY!!!

Location: Maryland
Duration: 1000 hours to perm
Interview: Phone then in person No SKYPE

This is a Senior Level role, min of 8 yrs of experience, with Lead project experience.
Strong experience leading GxP System updrade. 
Strong experience developing Validation Plans, Risk Assessments, and Protocols. 
 
JOB DETAILS
 
Lead a GxP systems upgrade project.
 
  • Evaluate an impacted system, participate in risk assessments to understand the impact to regulatory compliance, and establish a Validation Plan to validate the product for operational use.
  • Ensure the system meets the specified requirements per the process defined in the Validation Plan.
  • Draft test cases and scripts to meet Operational Qualification and Performance Qualification Testing objectives based on the system requirements.
  • When necessary, execute scripts to ensure the system release candidate functions as expected.
  • Report defects and problems, as per the Validation Plan.
  • Assist the project team to complete validation activities following Good Documentation Practices.
  • When necessary, participate as a Software Tester in verification activities to identify defects and ensure the system meetings requirements.
 
Candidate Skills:
 
  • 7 years of experience in writing validation plans, protocols, test scripts, and summary reports.
  • Strong knowledge of deliverables that a GxP system upgrade validation should provide, including validation plan, risk assessment, protocols, etc
  • Strong knowledge of deliverables that would be found in a validation binder for a system upgrade.
  • Knowledge of FDA regulatory requirements and how they apply to IT Systems.
  • Knowledge of software testing methods and best practices.
  • Knowledge of Good Documentation Practices.
  • Ability to program simple to moderate SQL scripts
  • Experience using risk management as an approach to developing test cases and focusing testing efforts.
  • Minimum three years' experience in Clinical, Medical, or Pharmaceutical space.
  • Experience in the use of Rational tools is a plus.
  • Experience in verifying Section 508, 21CFR11, GAMP5 or other regulatory requirements is a plus.
  • Flexibility in accepting special assignments including Business Analysis and Software Testing tasks.

Last updated on Mar 21, 2017

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