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Validation Specialist

2 months ago

Jersey City, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our computerized systems and equipment.

Key Responsibilities
  • Test Documentation and Execution: Prepare and execute test documentation for GMP computerized systems, providing support in the troubleshooting of issues during test execution.
  • Regulatory Compliance: Demonstrate an excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
  • Validation Coordination: Coordinate with multi-disciplinary validation teams to ensure the validation of automated equipment and control systems.
  • Documentation Creation: Create and modify validation documentation, including User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, CSV protocols (SAT, IQ, OQ, PQ), and reports summarizing the results of protocol executions.
  • Vendor Review: Review vendor documentation and ensure compliance with regulatory requirements.
  • Requirement Specification Review: Review and approve Requirement Specification documents.
  • System Implementation Plan Review: Review System Implementation Plans.
  • System Implementation Summary Report Review: Review System Implementation Summary Reports.
  • Test Script Review: Review and pre-approve ST/UAT Test Scripts in ALM.
  • Regulatory Risk Assessment: Create, update, and obtain approvals for Regulatory Risk Assessments (RRA).
  • Post-Execution Review: Conduct post-execution reviews and obtain approvals in ALM.
  • gR Implementation Approvals: Obtain approvals for gR implementations.
  • Retirement Plan Review: Review Retirement Plans.
Requirements
  • Requirement Document: Develop and maintain requirement documents.
  • Validation/Test Plan: Create and execute validation/test plans.
  • Requirement Traceability Matrix: Develop and maintain requirement traceability matrices.
  • Change Requests: Process and manage change requests.
  • Impact Assessment Document: Develop and maintain impact assessment documents.
  • Test/Validation Summary Report: Create and submit test/validation summary reports.