上海招聘

工作职责:

1. Be responsible for conducting production on-site inspection and in-process monitoring.

2. Be responsible for project related reviewing deviation, to ensure corrective and preventative actions are carried out and documented.

3. Be responsible for reviewing project related change control to ensure any changes are documented according to defined procedure and client requirement.

4. Be responsible for taking part in project related investigation, documentation and communication of GMP nonconformity.

5. Be responsible for ensuring that raw materials, packaging materials and intermediate, bulk and finished product are approved or rejected according to defined procedure or specification.

6. Review production/packaging batch record, work closely with manufacturing staffs, to perform elegance checking on the drug products and take release sample, retention sample per the instruction.

7. Perform visual inspection of equipment and room to ensure the effective cleaning; Review cleaning verification protocol. Verify cleaning swab sampling process; Release equipment after cleaning verification valid. Review logbook of equipment and rooms regularly.

8. Participate in internal audit, client audit.

9. Be responsible for MFG QA related SOP’s writing, revision and reviewing.

10. Be responsible for coordinating product recall or annual mock recall.

11. Be responsible for ensuring the implementation and supervision of quality assurance system.

12. Any jobs and responsibilities assigned by direct supervisor.

任职资格:

1. College degree or above

2. Pharmacy or related science discipline, GMP

3. English: good at writing and listening

4. N/A

5. Have 4 years above experience in drug manufacturing or R&D settings

6. Familiar with GMP quality assurance in pharmaceutical industry.

7. Knowledge of CFDA, FDA, EMEA GMP regulation

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.