Qualified Person

Act as the company’s Qualified Person under EU GMP; hold overall responsibility for GMP compliance across the organization; build and develop the internal GMP quality setup including quality processes, documentation, and scalable QMS structures; approve and oversee the Quality Management System (QMS); participate in and prepare for regulatory inspections and audits; handle deviations, CAPA, and change control processes; advise the organization on GMP and quality matters; contribute to establishing a robust and sustainable quality culture; serve as a key advisor to management on how quality and compliance are implemented.