Computer System Validation Specialist

7 days ago


Hartford, Connecticut, United States KVK Tech Full time
Job Overview

KVK Tech is seeking a highly skilled Computer System Validation Associate to join our team. As a key member of our Information Systems department, you will play a critical role in ensuring the accuracy and reliability of our computer-based systems.

Salary: $65,000 - $85,000 per year

Key Responsibilities
  1. Familiarize yourself with software development life cycle and GAMP5 approach to software implementation
  2. Collaborate with system owners to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix
  3. Develop procedures specific to GxP Application SOP's and provide SOP review for new systems
  4. Perform Part 11 Assessments for new and existing computer systems
  5. Perform periodic reviews of validated GxP Systems
  6. Maintain GxP System log and update as necessary
Requirements
  • Associates degree in related field from an accredited college or university preferred
  • One-year pharmaceutical industry experience preferred
  • Applicable knowledge of DEA regulations
  • Maintains a safe working environment
  • Organized
  • Demonstrates a high level of confidence, integrity and motivation
  • Handles confidential and non-routine information with poise, tact, and diplomacy


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