Senior Validation Specialist

4 days ago


Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time
Job Title: Senior Validation

As a key member of our engineering team, you will play a critical role in defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment. Your primary focus will be on ensuring optimal performance and output through the conduct of IQ, OQ, and PQ studies.

Key Responsibilities:
  • Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes.
  • Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc.
  • Ensure risks are properly identified and documented.
Requirements:
  • Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
  • Knowledge of current regulatory requirements and industry standards related to validation activities.
  • Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.


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