Biological drug development QA (reserve)Job description 1.To participate in the establishment, development and improvement of the quality system; Participate in the drafting and review of quality management documents, and supervise the implementation; 2.Supervise the quality and safety of R & D site, including site recording, equipment management, daily maintenance and personnel operation; 3.Participate in reviewing the reliability of R&D data; 4.Check and review the compliance of the original records, and put forward rectification suggestions. Job requirements 1.Bachelor degree or above, major in biomedicine; 2.Engaged in biological drug research and development related technical work, with more than two years of biological research and development QA experience; 3.Familiar with drug development process, drug registration laws and regulations, drug development guidelines, understand the drug production quality management standards; 4.Strong communication and coordination skills; 5.Good document writing skills. |