任职要求/岗位职责

工作职责：

支持建立和维持百济苏州工厂的合规文化，主动地符合法规要求。

Support to establish and maintain a culture of regulatory compliance at BeiGene Suzhou Site and proactively meets regulatory requirements.

确保本地GxP计算机化系统的开发，验证和维护满足cGMP和相关法规的要求。

Ensure development, validation and maintenance of local GxP CS are compliant with cGMP and related regulations.

负责建立或优化质量相关电子系统（如：LIMS，SAP），在满足业务发展需要的同时，确保其合规性。

Responsible for establishing and improving the quality related electronic systems to meet the business development needs and ensure the compliance. E.g. LIMS, SAP.

负责建立，维护或优化计算机化系统验证、定期回顾和再验证的流程。

Responsible for establishing, maintaining or optimizing the approach for computerized system validation, periodic re-assessment and revalidation.

参与或者领导百济跨工厂的数据可靠性提升项目。组织DI相关培训和分享行业***实践方案。

Lead or participate cross-sites Data Integrity improvement project. Provide relevant professional training, industry best practice sharing to site system owners.

与各部门建立和维护良好的沟通渠道，主动沟通和解决计算机化系统管理和DI相关的问题。

To establish and maintain good communication channels and mechanisms with other departments, actively communicate and solve problems related to computerized system management and DI.

参与建立和维护质量体系程序，确保质量体系满足现行GMP及相关法规的要求。

Participate in the establishing and maintaining of the Site Quality Systems & Compliance program to ensure cGMP and other regulatory compliant.

参与苏州工厂质量体系协调的项目，同GQA团队密切合作。

Participate in quality system harmonization program for site in close collaboration with GQA team.

参与管理法规检查和内、外审计，确保及时准备对审核发现项的回复。

Participate in managing the execution of regulatory inspections, internal and external audits, ensuring timely preparation of responses to observations.

执行检查的准备活动。 Execute inspection readiness activities for site.

参与建立并执行工厂自检工作。确保自检程序能够驱动工厂质量体系和流程的持续改进。

Participate in the establishment and execution of the site self-inspection program. Ensure the program drives continuous improvement of the site’s systems and processes.

日常工作符合EHS要求。

Routine activity meets EHS requirements. ·

执行主管安排的其他工作。

Perform the other tasks arranged by supervisors.

工作要求：

本科或以上学历，药学，生物学或化学专业

Bachelor or above degree in Pharmacy, Biology, Chemistry, etc.

专业知识能力 Professional knowledge

了解口服固体制剂或生物制剂生产工艺及实验室控制

Know about manufacturing process and Laboratory control of oral solid or biological products

熟悉GMP/GLP，GAMP5，数据可靠性的相关要求

Familiar with GMP/GLP, GAMP5, Date Integrity requirements

学习能力Learning ability

持续的学习能力获得新的知识或技巧以胜任工作的要求。

Continuously invest time and effort to gain new skills and knowledge required to succeed in the work.

沟通能力Communication

团队内部和外部的人员进行积极有效的沟通。

Show strong willingness to work closely with peers within and outside the team toward a common goal.

制药行业5年或以上工作经验，至少2年QA经验

At least 5 years pharmaceutical experience and at least 2 year QA experience

熟悉LIMS和SAP系统

Knowledge and experience of LIMS, SAP systems.

英语水平良好，熟练使用电脑

Good English and good computer skill

QA合规高级专员