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Quality Assurance Specialist

2 months 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, as well as excellent communication and collaboration skills.

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 and qualification protocols, procedures, and reports, ensuring timely completion and accuracy.
  • 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, ensuring timely and effective resolution.
  • Represent QA Validation in multi-functional meetings and projects, providing expert guidance and support.
  • Work closely with engineering to perform Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities and protocols.

Requirements

  • Relevant pharmaceutical/GMP experience, with a proven track record of success in validation and CSV roles.
  • Strong knowledge of GMP legislation and regulatory requirements.
  • Excellent communication and collaboration skills, with the ability to establish effective working relationships.
  • Ability to work in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously.

About Thermo Fisher Scientific

Thermo Fisher Scientific is a leading global biotechnology company that provides innovative solutions for the life sciences, healthcare, and environmental industries. Our company is committed to making a positive impact on society, and we are seeking talented individuals who share our values and passion for excellence.