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Validation Analyst

Katalyst HealthCares & Life Sciences

 

South Plainfield, NJ, USA

Posted On: Just posted
Experience: 2+ years
Availability: Onsite
Openings: 1
Category: Validation Analyst
Tenure: No Preference/Any
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Description

You will own validation activities across the software development life cycle to ensure systems meet business requirements and regulatory standards.

This role is on-site.

Responsibilities

  • Prepare and execute validation plans, test cases, and validation summary reports.
  • Review and approve change controls for validated systems in accordance with SOPs.
  • Create and manage test data within testing environments to verify software functionality.
  • Analyze software defects, assess causes of test failures, and provide feedback on timeline or resource constraints.
  • Participate in project meetings to identify user requirements and assist in preparing system documentation.

Required Skills

  • 2+ years of relevant experience in validation or software testing.
  • Solid understanding of the Software Development Life Cycle (SDLC).
  • Working knowledge of GCPs, applicable SOPs/WPDs, and process maps.
  • Experience reviewing functional design, system design, and test plans.
  • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project).
  • Strong troubleshooting skills to analyze software defects and test failures.
  • Understanding of clinical trials operational processes and terminology.

Preferred Skills

  • Ability to coordinate project activities within multi-disciplinary teams.

Education

Any Graduate

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