Senior Validation Specialist

1 month ago


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

As a Senior Validation Specialist at Proclinical Staffing, you will play a crucial role in supporting the engineering team by defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment.

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 in accordance with internal procedures, regulatory requirements, and industry standards.
  • Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented.
  • Collaborate with cross-functional teams to ensure alignment and effective implementation of validation strategies.
  • Stay up-to-date with current regulatory requirements and industry standards related to validation activities.
  • Contribute to the development of quality risk assessments and validation plans.

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.

About Proclinical Staffing:

Proclinical Staffing is a leading provider of staffing solutions for the life sciences industry. We are committed to delivering exceptional service and supporting our clients' goals.



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