广州招聘

Job Description 职位描述：
Responsible for monitoring process critical control point.
负责监控工艺过程关键控制点。
Responsible for in-process control of drug substance, to ensure that the production activities of drug substance meet the GMP and BeiGene requirements.
负责制剂生产工序的现场监控，确保制剂生产活动符合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。
Requirements 岗位需求：
Junior college 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。
Familiar with key quality control points of aseptic process.
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 1 year working experience in quality assurance or manufacturing or process improvement in pharmaceutical manufacturing enterprises.
至少一年药品生产企业质量保证或生产、工艺改进的工作经验。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.熟练应用常见的办公室软件，包括但不限于Word, Excel, PPT。
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 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.
? 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
求职者隐私申明：
百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。
由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。
如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。
BeiGene is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity.
Due to the reasonable business need for human resource management as a result of BeiGene’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeiGene Job Applicant Privacy Policy (BeiGene official website - Privacy Policy - Job Applicant Privacy Policy).
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.
职能类别：
质量管理/测试工程师(QA/QC工程师)
关键字：
在线QA

2017年3月，百济神州与广州开发区合作，建设生物药生产基地，直接投资额达22亿人民币。广州生物药生产基地主要生产大分子单克隆抗体类抗癌药。基地采用全球领先的现代生产设备KUBio整体解决方案。

我们的目标是致力于成为一家在癌症研究、药物研发、人才培养和商业准则方面具有全球影响力的公司。
在这里，您的每一分努力都将得到肯定，您的个人价值将在公司的发展中得到充分的体现。