上海招聘

工作职责:

1. 制定验证主计划，审核验证方案及报告，并跟踪执行

Formulate validation master plan, reviewing validation related documentation (SIA, URS, CCA, DQ/IQ/OQ/PQ protocols, records and reports).Track the implementation

2. 审核计量计划，方案及报告

Reviewing calibration schedules, protocols, records and reports.

3. 审核设备设施及维护维修相关文件

Reviewing facility and utility documents .

4. 审核设备设施相关偏差，CAPA,确保符合GMP 的要求

Reviewing deviations, CAPAs, making sure the corrective or preventative actions are in-line with cGMP, SOPs and are correctly documented.

5. 审核设备设施相关变更，确保符合GMP及相关文件的要求 Reviewing change controls, making sure any change are documented according to defined procedure and all impacted items are investigated.

6. 定期对设备设施现场进行质量监控

Perform site quality monitoring to facility and utilities.

7. 负责验证相关文件的制定与修订QA Validation related SOPs writing, revision and reviewing.

8. 参与质量内审Taking part in internal audit.

9. 其它主管指定的工作Any job and responsibilities assigned by the supervisor.

任职资格:

本科以上

Bachelor or above

制药或化学相关专业， In a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience.

英语流利Fluent in English

熟悉CFDA,FDA,EMEA GMP 相关法规, Knowledge of CFDA, FDA, EMEA GMP regulations

5年以上制药行业验证经验5 years above experience in validation of Pharma industry.

1. 设备设施确认

Good at qualification for facilities and equipment;

2. 工艺验证清洁验证Familiar with the process validation, cleaning validation, and computerized system validation;

3. 质量体系及相关现场质量知识Knowledge of quality system and related work on site.

1. 良好的沟通及总结能力Strong communication skills, both written and verbal, and outstanding interpersonal skills

2. 善于团队合作，以团队为导向完成工作目标Should be able to share information openly and work in a team-oriented manner 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.