QC Validation Specialist

Your mission

The QC Method Validation Specialist is responsible for the validation and technology transfer of novel and established
test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU
and FDA GMP requirements.

Job Description

Major Activities

• To support the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
• Generate validation test protocols, data analysis, and reports in support of the method transfer and validation activities performed ensuring compliance requirements are maintained.
• Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
• Generate method SOPs are developed and implemented to support all validated methods. Ensure these are current.
• Ensure timely communication to method transfer progress and plan adherence.
• Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
• Perform routine assessment of the analytical methods used to ensure they are being applied arid operating as expected.
• Support with maintaining the Quality Management System and controlling docume