上海招聘

Key accountabilities:

Responsible for generating and monitoring of VMP, and maintaining and improving of validation system

Responsible for writing and reviewing the qualification protocols, reports, operation SOPs and GMP documentations in compliance with the requirement of EU, FDA and SFDA

Perform the execution of qualifications, cleaning validation and maintenance of validation equipment.

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

Support the activities of facility’s design, commissioning and qualification, and review the related documentations

Assist internal and external audit, write response report and follow up the corrective actions to ensure the actions complete timely

Provide validation and SOP trainings.

Be accountable and demonstrate good working ethics, integrity, ownership and leadership.

Scope of the job:

Complete all the qualification document, SOPs and GMP related documentation on a timely manner.

Conduct the work assignments in compliance with cGMP regulations whenever applicable.

To communicate with and assist different group or department in a timely manner to fulfill the work assignment of high quality and efficiency.

Depending on the focus area and individual expertise, demonstrate the capability to fulfill the work assignment of high quality.

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

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.