高级QA工程师 (MJ016416)

Responsible for in-process control of drug product/ADC, to ensure that the production activities of drug substance meet the GMP and BeiGene requirements.

负责制剂生产工序/ADC的现场监控，确保生产活动符合GMP和法规要求。

Responsible for timely reporting deviations and other quality issues in the production process, assist in deviation and abnormal situation investigation and risk assessment, ensure that deviations and abnormal events are fully investigated, and effective corrective and preventive measures are taken.

负责及时向上汇报生产过程中的偏差及异常事件，协助偏差及异常情况的调查及风险评估，确保偏差和异常事件得到充分调查并采取有效的纠正预防措施。

Supervise the clearance of each process in strict accordance with the clearance management system, supervise the status signs, and supervise the implementation of relevant GMP documents in the whole production process, supervise Data Integrity.02

严格按照清场管理制度监督各工序清场情况，监督状态标识的使用，监督GMP文件在生产全过程的执行情况，监督数据可靠性。

02Responsible for batch production record audit.

负责批生产记录关键质量控制点的审核。

Supervise the disposal procedure of rejected products.02

监督不合格品的处理情况。

02Support the investigation of internal and external audit processes and findings, review corrective reports, ensure audit findings are fully investigated and develop reasonable corrective and preventive actions.

支持内外部审计过程及审计发现项的调查，审核整改报告，确保发现项得到充分调查并制定合理的纠正预防措施。

Responsible for DP system documents and CMC documents review.

负责制剂生产体系文件及CMC文件的审核。

As POC of Quality Assurance, responsible for project quality management, cross-department communication, project quality risk management, quality procedure control, change control assessment and any abnormal follow up.

作为质量保证部门的代表，负责项目质量管理，执行相关的跨部门沟通、项目质量风险管理、质量流程控制、变更评估及异常跟进。

02Follow the company EHS policy and procedure; fulfill responsibility of EHS related regulation, timely report EHS accident and risk.

遵守公司各项EHS规章制度；履行EHS相关法规责任，即使汇报EHS相关事故及隐患。

02Any other assignment as is determined by supervisor.

完成上级安排的其他工作。

02

Bachelor or above degree in Pharmaceutical, Chemical, Biology, Microbiological or related field.

药学，化学，生物学、微生物学或相关学科学士或以上学位Application of NMPA GMP, EU GMP, PIC/S GMP and FDA cGMP

应用中国GMP，欧盟GMP，PIC/S GMP及美国GMP

Master Drug management regulation/Manufacturing management regulation

掌握药品管理法/生产监督管理办法等法规

Master Registration management regulation and so on02

掌握注册管理办法以及相关法规

Application of on-site quality management procedure

应用现场质量管理流程

Application of batch record review requirements

应用批记录审核要求

Application of deviation and OOX investigation principle.

应用偏差及超标/超趋势调查原理

010202 02Master audit trail review requirements

掌握审计追踪审核要求

010202 02Application of knowledge of Visual Inspection02

应用人工灯检知识

Application of biological products key quality control points

应用生物制品关键质量控制点

02Master quality risk management process and tools.

掌握质量风险管理工具

02Master knowledge of HVAC system and process water operation and monitoring

掌握空调系统及工艺用水系统运行及监控的基本知识

Master Change Control management process and have the ability to conduct change evaluation on behalf of quality assurance

掌握变更管理流程并具备代表质量保证进行变更评估的能力

Maester knowledge of phase-appropriate quality system

掌握阶段性质量管理体系

Master knowledge of tech transfer process

掌握技术转移知识

Master Manufacturing Process basic knowledge

掌握生产工艺基本知识

02Strongly address, investigate and solve ability

具有较强的处理，分析和解决问题的能力

Strong communication, presentation and decision-making skills

具有较强的沟通、表达及决策能力

At least 5 years relevant experience in quality assurance or manufacturing or process improvement in pharmaceutical manufacturing enterprises with bachelor’s degree, or

本科学历，至少5年药品生产企业质量保证或生产、工艺改进的工作经验，或

At least 3 years relevant experience in quality assurance or manufacturing or process improvement in pharmaceutical manufacturing enterprises with master’s degree, or

硕士学历，至少3年药品生产企业质量保证或生产、工艺改进的工作经验，或

No work experience but Doctoral degree

无工作经验，博士学历Master office software, including but not limited to Word, Excel, PPT and Visio or equivalent tools;

掌握办公软件，包括但不限于Word, Excel, PPT及Visio或同等功能软件；

Ability to Read English regulations, guidelines and documents related to job responsibilities, write English emails and standard operating procedures.

掌握工作职责相关的英文法规、指南及文件的阅读，英文邮件及标准操作规程的撰写。

02

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。

●团队协作

●提供并征求坦诚及可行的反馈

●自我认知

●兼容并蓄

●积极主动

●开拓精神

●持续学习

●拥抱变化

●结果导向

●分析性思维/数据分析

●卓越财务

●清晰沟通

BeiGene Global Competencies

When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

●Fosters Teamwork

●Provides and Solicits Honest and Actionable Feedback

●Self-Awareness

●Acts Inclusively

●Demonstrates Initiative

●Entrepreneurial Mindset

●Continuous Learning

●Embraces Change

●Results-Oriented

●Analytical Thinking/Data Analysis

●Financial Excellence

●Communicates with Clarity

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If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.