上海招聘

工作职责:

1. Working in Gilead Analytical Center as QA Specialist to ensure the compliance of daily operation.

2. Reviewing test protocol, records and reports and issue CoA for project and product. Ensuring Specifications, sampling instructions, test methods and other procedures related with GMP operation are effective before using.

3. Coordinating OOS/OOT/OOA/ATY, deviations, CAPA, making sure the corrective or preventative actions are carried out and documented and maintaining the trace system to prevent deviations from re-occurring.

4. Coordinating change control, making sure any change are documented according to defined procedure and all impacted items are investigated.

5. Gilead Analytical Center related SOPs and QA related SOPs writing, revision and reviewing.

6. Periodical quality evaluation with Gilead Analytical Center

7. Taking part in internal audit and routine inspection.

8. Any job and responsibilities assigned by direct supervisor.

任职资格:

1. Must have experience in GMP.

2. Must be trained in or have experience with the requirement of SFDA, FDA, EMEA GMP regulation.

3. BS, MS or PH.D degree in a science discipline with experience or training in Chemistry, Pharmaceutical, or equivalent experience.

4. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.

5. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

合全（sta）是药明康德全资子公司，其中包括：上海合全药物研发有限公司( 原药明康德工艺研发部，上海外高桥)，合全药物公司是sta 专门从事工艺合成路线研发及放大实验的研发团队；合全药业金山公司和常州公司是sta 提供符合cgmp 标准的中式放大及商业化生产的基地。
shanghai syntheall pharmaceutical co., ltd. is a wholly-owned subsidiaries of wuxi app tec, including:
sta r&d is professional in route selection and process scaled up r&d;sta jinshan and changzhou are the pilot plants and commercial production base under cgmp.

sta 公司愿景 sta vision：
改变创新药api 的工艺研发和生产模式，加快新药研发速度，降低新药成本，造福人类健康。
transform how industry develops and manufactures apis, shorten the time and lower the cost of new drug developments, improve the quality of life.

sta 公司使命 sta mission：
不断创新、不断完善创新药api 的工艺研发以及研发和商业化生产的一体化平台，为全球新药研发机构提供最优质***效的api 工艺研发和生产一体化服务和***解决方案。
constantly enhance the capabilities of our fully-integrated api development and manufacturing platform from preclinical batches to commercial supplies, provide highly efficient and cost-effective solutions to our partners worldwide.