Analytical Methods Specialist

17 hours ago

Shannon, Ireland beBeeValidation Full time
Job Title: QC Validation SpecialistOverview

The QC Validation Specialist is responsible for ensuring the quality and integrity of analytical methods used in the production of gene therapy products. This includes validating and transferring test methods to ensure compliance with regulatory standards such as EU and FDA GMP requirements.

Key Responsibilities
  • Develop and validate established and novel analytical test methods for current and newly developed gene therapy products.
  • Generate validation test protocols, data analysis, and reports to support method transfer and validation activities.
  • Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards.
  • Implement SOPs for validated methods to ensure they are up-to-date and current.
  • Communicate effectively with stakeholders on method transfer progress and plan adherence.
  • Assess analytical methods regularly to ensure they are operating as expected.
  • Support the Quality Management System and control of documents to ensure data integrity.
Requirements
  • Master's degree or higher in human health or sciences.
  • At least 2 years of experience in a regulated industry such as pharmaceuticals or biologics.
  • Experience in an analytical methods/validation role in research or pharmaceutical industry.
  • Knowledge of analytical techniques such as qPCR, HPLC (RP-HPLC/SEC), ELISA, SOS/Western blot, cell-culture and DNA extraction.
  • Proficiency in ICH Q2(R1) guidelines.
  • Proficiency in IT, Microsoft Office software (Word, Excel, PowerPoint).
Why this Role?

This role offers the opportunity to work in a dynamic environment and contribute to the development of innovative gene therapy products. If you have a passion for quality assurance and a strong background in analytical sciences, this could be the perfect fit for you.

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