1、Implementing drug quality management laws and regulations, performing routine GMP duties, and ensuring that the manufacturing process of raw liquids meets the company's requirements and relevant regulatory requirements.

2、Participate in writing and auditing quality management system documents to improve the company's quality system; responsible for auditing production related documents and records, such as process protocols, operation and equipment SOPs, MBR, etc..

3、Responsible for daily inspection of production workshops, supervising the implementation of GMP activities, timely identification of on-site problems, feedback and follow-up of their rectification plans.

4、Responsible for quality supervision and site inspection during cell building and stock solution production to ensure that the production process is executed according to process protocols and SOPs and meets GMP requirements.

5、Responsible for the handling of production site abnormalities, assisting the deviation leader to complete the root cause investigation of deviations, risk assessment and develop appropriate CAPA measures, reviewing the quality of deviation reports and following up their completion.

6、Responsible for batch production records and electronic data review to ensure that they meet the requirements of process and data integrity.

7、Collect and review records related to product release and complete product release.

8、Participate in official and/or third party audit activities of the company, cooperate in providing relevant training documents and records during audits, and provide answers when necessary.

9、Complete other work assigned by the supervisor.

1、Bachelor degree or above, majoring in pharmacy or biology.

2、At least 3 years working experience in pharmaceutical companies, understanding of biologics production site supervision and release related work

3、Familiar with GMP/cGMP/EU GMP and other related regulations.

4、Ability to read, write and speak English is preferred.

5、Familiar with the operation of word, excel and other common office software.

6、Clear thinking, strong sense of teamwork, good communication,coordination and service consciousness, strong execution ability.