Analytical Validation Expert

1 week ago

Shannon, Ireland beBeeValidation Full time €55,000 - €80,000
Job Opportunity

Proactively lead the validation of test methods and ensure compliance with EU and FDA GMP standards.

This role involves contributing to the development of cutting-edge analytical techniques.

Please note that you must have the right to work in this location.

Key Responsibilities
  • Develop and validate new and existing test methods for gene therapy products.
  • Create and analyze protocols, reports, and data to support method transfer activities.
  • Ensure all methods meet regulatory standards and maintain data integrity.
  • Write and update standard operating procedures (SOPs) for validated methods.
  • Communicate progress and updates on method transfers to stakeholders.
  • Regularly review analytical methods to ensure they are functioning as expected.
  • Support the maintenance of the Quality Management System and document control processes.
  • Track and achieve personal goals and timelines effectively.
  • Perform testing of gene therapy products when required, ensuring alignment with production schedules.
Required Skills and Qualifications
  • Background in human health or sciences with relevant qualifications.
  • Experience in quality control or analytical method validation in a regulated industry.
  • Familiarity with techniques such as qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction.
  • Knowledge of ICH Q2 R1 guidelines and proficiency in Microsoft Office tools.
  • Strong organizational and communication skills.
Benefits

This opportunity offers a chance to contribute to the development of innovative analytical techniques.

Application Information

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this opportunity, please click "Apply" or visit the "Contact Us" page to speak with one of our specialists.

By submitting your application, you confirm that you have read and understood our privacy policy.


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