The responsibilities encompass a wide range of tasks; act as lead in the maintenance of the quality system, including e.g. regulatory surveillance, preparation the quality management review, supplier management and lead in quality improvement projects; act as superuser of the eDMS system, including continuous improvement and access management; act as lead in audit and inspection management; act as an internal Quality consultant on applicable regulations and related topics and translate these into daily practice and improvement of the QMS by developing and providing applicable trainings; advise on design of computerised systems validations and process validations including; cleaning validation, sterilisation validation, media fills and decontamination processes of clean rooms; act as mentor to (junior) QA specialists.