Job Summary
The Quality Assurance Validation Specialist plays a crucial role in ensuring the accuracy and reliability of our gene therapy products. This position requires an individual with expertise in analytical method development, validation, and technology transfer.
Main Responsibilities
* Develop and validate analytical test methods for gene therapy products.
* Generate validation test protocols and data analysis reports.
* Evaluate and maintain compliance with regulatory standards, including EU and FDA GMP requirements.
* Perform routine assessments of analytical methods to ensure they are operating as expected.
* Oversee the Quality Management System and control documents.
Requirements
* A degree or master's in human health sciences or a related field.
* At least two years of experience in the pharmaceutical or regulated industry.
* Experience in an analytical methods/validation role in the research or pharmaceutical industry.
* Proficiency in ICH Q2 (R1) guidelines and IT, Microsoft Office software.
Preferred Skills
* Familiarity with analytical techniques such as qPCR, HPLC, ELISA, SOS/Western blot, cell culture, and DNA extraction.