Gene Therapy Quality Assurance Specialist

5 days ago

Shannon, Ireland beBeeAnalytical Full time €60,000 - €80,000
Gene Therapy Quality Assurance Role

The Gene Therapy Quality Assurance Specialist plays a pivotal role in ensuring the quality and integrity of gene therapy products and associated materials.

  • To support the development and validation of established and novel analytical test methods for current and newly developed gene therapy products. This involves collaborating with cross-functional teams to optimize testing protocols and ensure compliance with regulatory standards.
  • Generate comprehensive validation test protocols, data analysis, and reports to support method transfer and validation activities. The ideal candidate will have excellent technical writing skills and be able to communicate complex scientific concepts effectively.
  • Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and data integrity requirements. This requires a strong understanding of Good Manufacturing Practices (GMPs) and regulatory guidelines.
  • Develop and implement method SOPs to support all validated methods. This involves working closely with stakeholders to identify areas for process improvement and implementing changes that enhance efficiency and productivity.

Key qualifications for this role include a degree or Master's in human health or sciences, 2 years' work experience in the pharmaceutical or regulated industry, and experience in analytical methods/validation roles. Proficiency in IT, Microsoft Office software, and knowledge of ICH Q2 (R1) guidelines are preferred. Additionally, excellent communication and collaboration skills are essential for success in this position.

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