• 招聘类型：社招
• 工作性质：全职

职位描述

1、Responsible for the establishment and implementation of the company's quality strategy and quality policy to ensure the company's compliance to China and FDA/EU GMP.

2、Responsible for managing the company's quality operations. Serve as the QP (qualified person) for the releases of both APIs and final products.

3、Responsible for the management and implementation of FDA/EU cGMP certifcation/compliance-related projects. Serve as the internal lead for receiving the EU/FDA cGMP inspections. Support regulatory registration of the company's products in the EU and the US.

4、Serve as an internal quality management expert and support the quality management for the whole Group.

任职条件

1、 BS degree or above in pharmaceutical science, engineering, chemistry, or related majors.

2、 10+ years experience in quality management ( APIs, solid dose, freeze-dried powder, injectables,etc.). Overseas working experience is preferred.

3、 Excellent knowledge in the pharmaceutical industry, GMP, quality control, and regulatory affairs.

4、 Hands-on expeience in FDA/EU cGMP inspections is a must. Experience in managing FDA/EU cGMP compliance-related projects is preferred.

5、 Excellent English skills.

职位要求

• 学历要求：本科
• 工作经验：10年
• 外语要求：不需要