• 招聘类型：社招
• 工作性质：全职

职位描述

1.Establish, develop and maintain a highly efficient quality control team in accordance with cGMP regulations and Beigene’s standards

2.Oversee the development and implementation of Quality Control strategy. Oversees generation, review and compliance of locally developed and approved procedures with company-wide quality policies and standards.

3.Ensure the compliance of QC activities with GMP, GLP, and other regulatory requirements and the relationship and communication with the authorities, internal and external customers to keep the high quality expectation of Beigene products.

4.Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Beigene policies and standards

5.Build a high efficient QC team, identify and develop key talents within the QC area.

6.Direct QC Staff in the timely completion of testing (e.g. DS, DP release and stability testing, raw materials testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

7.Ensure adequate resources and analytical capability. Provide QC staff with technical guidance on test methods and relevant procedures. Lead the team to build up analytical capability for large molecular products to further support company’s biologics business.

8.Complete any other task as is determined by supervisor.

任职条件

1.Master degree and above in Pharmacy, Biology, Chemistry concerned.

2.At least 10 years QC experiences of biological products, familiar with biochemical testing and bioassay of biological products and at least 5 years QC supervisory/managerial roles

3.fluent English in spoken and written

4.Familiar with the regulatory requirement of NMPA cGMP/GLP、EU cGMP/GLP、PIC/S cGMP and FDA cGMP/GLP.

5.Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry

6.Show strong willingness to work closely with peers within and outside the team toward a common goal.

7.Sets a highly ambitious, clearly prioritized vision for the team; provide clear direction and define priorities for the team; listen to the different voices and win the commitment of team members

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日