Validation and Compliance Expert

1 week ago


Horsham, West Sussex, United Kingdom Thermo Fisher Scientific Full time

Job Summary

As a QA Validation Specialist at Thermo Fisher Scientific, you will play a critical role in ensuring the quality and integrity of our products and processes. This position requires a strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities

  • Provide validation support to various departments, including equipment, systems, and facilities, to ensure compliance with regulatory requirements.
  • Lead and coordinate validation and qualification activities, including equipment, facilities, systems, cleaning, distribution, and computerized systems validation (CSV).
  • Develop and maintain validation protocols, reports, and documentation to ensure site compliance and adherence to regulatory requirements.
  • Collaborate with cross-functional teams to identify and implement process improvements and optimize validation activities.
  • Conduct root cause analysis and deviation resolution for validation exceptions.
  • Represent QA validation in multi-functional meetings and projects as required.

Requirements

  • Relevant pharmaceutical or GMP experience.
  • Previous experience in validation or CSV roles.
  • Knowledge of GMP legislation and regulatory requirements.
  • Excellent communication and presentational skills.
  • Ability to establish effective working relationships and communicate effectively with stakeholders.


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