上海招聘

工作职责:

? 1. Responsible for PDS validation and calibration work including equipment validation, cleaning validation or verification, computer validation, facility and utilities validation.

2. Manage project timeline to ensure new facility and equipment installed and qualified according to schedule.

3. Responsible for writing and reviewing qualification protocols, reports, validation SOPs and GMP documentations in compliance with the requirement of EU, FDA and CFDA

4. Manage all qualifications work and calibration work to ensure qualification/calibration activities follow protocols, GMP regulation or guidance requirement.

5. Responsible for VMP, validation annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning.

6. Responsible for internal audit and external audit related to qualification and calibration.

7. Expertise in validation/calibration area, demonstrate the capability to fulfill the work assignment of high quality

8. Be able to work in a team environment and manage the work assignment by interacting closely with colleagues and by developing cooperative working relationships with other personnel inside the company.

任职资格:

1. BS or Master Degree in pharmaceutical or engineering.

2. At least eight years work experience in validation area of pharmaceutical industry and with 3 years‘ experience of managing validation team.

3. Good English skills including writing, reading and oral.

4. Has good experience on project management for new GMP facility commissioning and qualification, and has a good record of passing FDA, EMA or CFDA inspection.

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.