北京招聘

Major Responsibilities and Duties:

1. Support QMS daily work including:

1) SOP management and archive management

2) Coordinate to draft training plan, collect and maintain training material, organize the training, and retain training records and personnel file summary;

3) Maintain deviation, change control, and CAPA records and follow up with open cases;

4) Support vendor management to maintain the relevant documentation;

5) Support internal audit, vendor audit, site audit and regulatory inspection;

6) Support other quality related activities or tasks assigned by the leader, e.g., periodic QA summary;

2. Support discovery lab to comply with the Good Documentation Practice and basic requirements of Good Laboratory Practice

3. Be a role as SH, SZ, and HK coordinators to support communication and teamwork of product pipeline.

Qualifications:

1. Bachelor of Science or above in medical or pharmacy or a life/biological science or quality-related field, or equivalent combination of education, training and experience.

2. Good communication skill

3. Able to work in a team as well as to work independently

4. Fluent in English

5. Good computer skills including Microsoft office and PDF.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。