上海招聘

KEY ACCOUNTIBILITIES:
1.Familiar with the business model of CMO/CDMO in pre-Clinical stage;
2.Champion the effort of preparations (computerized systems only) for audits from customers and inspections by regulatory bodies and respond to findings (computerized systems only) from audits and inspections;
3.Act as the key contact person / SME for all issues related to computerized system compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication;
4.Lead computerized system validation and quality SME and provide strategic guidance determine and establish validation requirements for computerized systems based on regulatory, IT QMS, and industry best practices, lead the development of system specific validation plans and strategy using a risk-based approach, etc..
5.In charge of the development and maintenance of the Standard Operating Procedures, Work Instructions, user guides, and other relevant documentation for IT QMS establishing and improving;
6.Conduct compliance investigation to different sites and guide team to follow standard IT compliance procedure to site IT operation;
7.Works closely with IT team in identifying, evaluating, selecting, and implementing specific information technologies that support the business plans and IT strategies;
8.Maintains a strong understanding of technology and lab/pre-clinical applications. Continuously learn new technologies;
9.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:
1.6+ years of working experience in Chemical / Pharmaceutical industry including 3+ years’ experiences in Computerized System Validation or other QA Function;
2.Understand Waterfall / Scrum / Agile methodology to communicate with IT teams.
3.Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines and Governance in a fast paced environment.
4.Strong written and verbal communication and presentation skills. Proficient in tools like Power Point, Visio and other tools to develop process flows and presentations.
5.Quick learner and keeps current with emerging technologies in GxP space.
6.Detail-oriented with expertise in problem solving, analytical and critical thinking skills. Strong interpersonal skill in working with IT function and business leaders;

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.