Biological drug development QA (reserve)
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.
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.