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Gene Therapy Product Validation Expert
3 weeks ago
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.
- 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.
- Familiarity with analytical techniques such as qPCR, HPLC, ELISA, SOS/Western blot, cell culture, and DNA extraction.
