- Responsible for monitoring process critical control point.
- 独立履行原液工艺过程关键控制点的监控。
- Responsible for in-process control of drug substance, to ensure that the production activities of drug substance meet the GMP and BeiGene requirements.
- 负责原液生产工序的现场监控,确保原液生产活动符合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.
- 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。
- 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.
- 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。
- Responsible 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.
- 监督不合格品的处理情况。
- Support 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。
- Any other assignment as is determined by supervisor.
- 完成上级安排的其他工作。
- College degree or above in Pharmaceutical, Chemical, Biology, Microbiological or related field.
- 药学,化学,生物学、微生物学或相关学科大专或以上学位Familiar with the regulatory requirement of NMPA GMP, EU GMP, PIC/S GMP and FDA cGMP.
- 熟悉NMPA GMP, EU GMP, PIC/S GMP and FDA cGMP的要求。
- Familiar with GMP compliance requirements and management methods in production site.
- 熟悉生产现场GMP合规性的要求及管理方法。
- Master in deviation and OOX investigation process and tools.
- 掌握偏差、OOX的调查流程及方法。
- Understand biological products (such as antibodies, vaccines), cell culture and/or purification of key quality control points.
- 了解生物制品(如抗体、疫苗)细胞培养和/或分离纯化的关键质量控制点。
- It is good to master the key quality control requirements of biological products production in stainless steel production line.
- 掌握不锈钢生产线生物制品生产关键质量控制要求为佳。
- Strongly address, investigate and solve ability.
- 具有较强的处理,分析和解决问题的能力。
- Strong communication and presentation skills.
- 具有较强的沟通及表达能力。At least 3 years relevant experience in quality assurance, manufacturing, or process technical in pharmaceutical company, or no working experience but have a full-time master's degree or above.
- 至少3年制药企业质量保证、生产或工艺技术的工作经验,或无工作经验但是具备全日制硕士研究生及以上的学历。Good command of English, able to read and understand industry English regulations and literature, able to review and write English documents.
- 英语水平良好,能阅读并理解行业英文法规及文献,能审核并撰写英文文件。
- Familiar with office software, including but not limited to Word, Excel, PPT and Visio or equivalent tools
- 熟悉常用办公软件,包括但不限于Word,Excel,PPT,Visio或等同的工具。
- 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
- 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
QA Engineer QA 工程师 - Guangzhou Shi, 中国 - BeiGene
描述
Job Description:
Qualification Required:
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。
BeiGene Global Competencies
When we exhibit our values of Patients First, 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.
求职者隐私申明:
百济神州致力于尊重和保护求职者的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理求职者的个人信息(包括个人敏感信息,如有)。更多详情,敬请查阅百济神州《求职者隐私政策》。
由于百济神州在全球范围内开展业务,我们需要基于集团人力资源统筹管理的合理业务目的而向百济神州关联公司(BeiGene Ltd.)提供求职者的简历及求职信息,求职者的信息将被存储在位于中国境外(目前位于美国)的Workday数据库。如需行使中国法律规定的各项个人信息权利,可通过联系BeiGene Ltd.
Due to the reasonable business need for human resource management as a result of BeiGene's global operation, job applicants' resume and job application relevant information may be provided to the BeiGene affiliate (BeiGene Ltd.), and the aforementioned data will be stored in Workday (currently located in the U.S.). If the job applicant wishes to exercise his/ her personal information rights provided under PRC laws, he/ she may contact BeiGene Ltd. via
如您主动向我们提供您的个人信息,则视为您已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。如您主动向我们提供其他求职者的个人信息,则视为您确认相关人员已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to BeiGene's Job