上海招聘

KEY ACCOUNTIBILITIES:

1. Familiar with the business model of CMO/CDMO in pre-Clinical stage.

2. Be responsible for assisting in the timely development and execution of computerized system validation projects and documentation such as validation lifecycle documentation and quality records (e.g., SOPs, Change Controls, CAPAs, Deviations, etc.), ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices.

3. Organize all validation activities to ensure completion of projects per schedule requirements.

4. Support all aspects of the Validation Life Cycle from design through operation and maintenance.

5. Support the revalidation program. Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.

6. Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives for computerized systems.

7. Works closely with IT team in identifying, evaluating, selecting, and implementing specific information technologies that support the business plans and IT strategies.

8. Understand Waterfall / Scrum / Agile methodology to communicate with IT teams.

9. Maintains a strong understanding of technology and lab/pre-clinical applications. Continuously learn new technologies

10. As part of STA IT team, work closely with pre-clinical and discovery solution delivery directors to make the entire RND lifecycle application fully integrated             

REQUIREMENTS:

1. 3+ years of experience including 2+ years’ experiences in computerized system validation.  

2. Familiar of application lifecycle management and application system administration.

3. Deep knowledge and expertise in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, Appendix I of CFDA GMP, GAMP 5, and ICH Q9/Q10.

4. Proficiency in: ERP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT

   systems;.

5. Result driven nature; Never stop learning.

6. Demonstrates strong business minded consultative approach;

7. Prefer Chemical / Pharmaceutical industry experience.

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.