1.本科及以上学历，生物学、生物化学、药学、化学等相关专业;
2.制药/API行业质量保证（QA）的知识和经验;
3.熟悉欧盟、中国及美国GMP 法规及计算机系统管理相关要求；
4.熟悉小分子，药品或生物制药生产，检测相关管理要求；
5.良好的沟通协作能力;
6.良好的计算机办公技能;
7.良好的英文听说读写能力尤佳;
8.熟悉质量体系要求，熟练进行变更，偏差的调查，评估及相应CAPA的建立，追踪。

1. Bachelor degree or above, biology, biochemistry, pharmacy, chemistry or other related
specialties;
2. Knowledge and experience of quality assurance (QA) in the pharmaceutical/API industry;
3. Familiar with GMP regulations and computer system management requirements in the European Union, China and the United States;
4.Familiar with small molecule, pharmaceutical or biopharmaceutical production, testing related management requirements;
5.Good communication and coordination skills;
6.Good computer skills;
7.Perfect for good English listening, speaking, reading and writing skill;
8.Be familiar with the requirements of quality system, and skilled at the investigation and evaluation of changes and deviations as well as the establishment and tracking of corresponding CAPA.