职位描述：
Job description： 1.Responsible to identify and transform GMP requirements and relevant regulatory requirements into local quality management procedure. Conduct gap analysis with risk perspective and be in charge of SOP creation and review work to ensure all processes are defined properly. 2. Monitor routine operations including but not limited to production process, QC process, engineering process, material management process and training process to ensure full compliance with GMP and local QMS as well as meet defined Q-KPI target. 3.Conduct RCA process and make sure all deviations can be identified sufficiently and corrected properly. 4.Conduct or participate Change process to ensure all possible risks can be identified and evaluated sufficiently as well as controlled properly. 5.Join qualification and validation activities. 6.Join GMP training program. 7.Improve local QMS continuously. 8.Others. Requirements： 1. Bachelor or above of pharmacy, chemistry, microbiology or related specialty. 2. At least 3 years QA working experience in pharmaceutical industry of sterile product with experience in working at international level. 3. Be familiar with manufacturing knowledge including sterile product technology and GMP regulation expertise of EMA and CFDA. 4. Be experienced of RCA, Change Control Risk assessment, Computerized system management and data integrity management and so on. 5. Excellent writing and communication skills, and be with persistence and commitment . 6. Skillful in using office application software (MS-Word, MS-Excel, MS-Project, MS Power Point, MS-Outlook) . 7. English Fluent in Read, and Good in Speak and Write. 8. Ability to work independently and flexible. 9. Chinese nationality. 举报