Purpose of Job

The QC 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.

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 and operating as expected.
• Support with maintaining the Quality Management System and controlling documents and ensuring the data integrity of all data produced.
• Ensure own KPI's, plans, targets, and objectives are effectively tracked, monitored, and achieved in accordance with timelines.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
• When required may be assigned testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule.