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Quality Assurance Validation Specialist

2 months ago

Jersey City, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Develop and implement testing documentation for Good Manufacturing Practice (GMP) computerized systems while identifying and resolving issues during the testing phase.
  • Possess a thorough understanding of relevant regulations and validation methodologies.
  • Collaborate with the validation team on automated machinery and control systems.
  • Draft and update validation documents including User Requirement Specifications (URS), Design Reports (DR), Computer System Validation (CSV) protocols, and related reports.
  • Evaluate vendor documentation, requirement specifications, and system deployment strategies.
  • Assess and endorse System Testing/User Acceptance Testing (ST/UAT) scripts, Risk Assessment (RRA), and implementation endorsements.
  • Conduct reviews of retirement plans.
Essential Requirements:
  • Documentation of requirements, validation/test plans, requirement traceability matrices, change requests, impact assessments, and test/validation summary reports.