确保新产品及商业化产品包装工艺及Artwork管理相关活动遵循注册和GMP要求以保证持续提供符合质标准的产品, 通过合理的工艺及包材优化加强技术控制和降低成本。
Ensure all packaging process and artwork management related activities for new produts and commercial products are conducted following registration and GMP requirement to assure the continuous supply of products with qualified standard, through process optimization to enhance control and reduce cost
1.02 在NPI项目中，参与新产品包材的评估，负责新产品包装工艺的开发和优化，并协调问题的解决
02020202020202 In NPI project, participate the pakcaging materials assement, responsible for the packging process development and optimiation, coordinate the soution of problems.
2.02 负责NPI项目及商业化产品包装批记录以及工艺规程（包装）的起草、优化和管理
0202020202 Responsible for packaging batch records & manufacturing process instruction (packaging)development、optimization and management
3.02 负责临床贴签批记录的起草、优化和管理
02020202 Responsible for batch records development、optimization and management for the clinic produts labeling
4.02 计划、协调和实施包装工艺验证活动
02020202 Plan, coordinate and exection of packaging process validation activities
5.02 参与新产品上市前的Artwork的设计，负责商业化产品Artiwork的管理工作
02020202 Participate the new projects artwork design, responsible for commercial products artwork management
6.02 参与包装设备/备件的URS编写，FAT，SAT，调试和验证
02020202 Participate the packaging equiments/parts URS drafting, FAT, SAT, commision and qualification
7.02 领导包材供应商变更，负责变更过程中的问题协调
02020202 Lead packaging material source change, responsible for the issues solving during the changing
8.02 负责包装工艺相关的变更和偏差调查
02020202 Reponsible for the packaging process change and deviation investigation
9.02 鉴别并实施包装工艺的持续改进机会02
02020202 Identify and implement opportunities of packaging continuous improvement
10. 和NPI团队合作，参与产品工厂/生产车间转移项目，参与产品获批后的首批商业化生产和供应商项目，确保项目按计划成功完成
02020202 Work closely with NPI team, be involved in technical transfer, new product launch project, to ensure the successful project delivery
11.02 其他领导安排的任务
Other tasks assigned by the line manager
大学本科以上学历，包装工程/生产/工程/生物/医药或相关专业毕业。
Bachelor or above education in Pakcaging Engineering, Manufacturing, Engineering, Biochemical Engineering, Pharmaceutical Science or related subjects.
具有在跨国大型药企的工作经验
MNC big pharma working experience.
至少3年以上药品生产企业经验
Minimum 6 years experience in pharmaceutical manufacturing environment
具有包装工艺开发、技术转移、产品转移的经验
Experience in Process development,02 Technical Transfer, Product Transfer
不同包装形式药品生产经验，至少有瓶包和泡罩包装经验
Experience in different packaging forms, bottle & blister packaging experience is a must
有项目管理及团队管理经验者优先
Preferred experience in project management and team management
丰富的GMP知识、基本的EHS知识
Knowledge and understanding of GMP, basic EHS Knowledge
了解包材的变化对产品质量的影响
Understands the impact of packaging material changes on product performance
包装相关工艺和设备知识
Knowledgeable of packaging process and equipment
包装工艺开发方面的知识，有材料科学方面的知识更好
Knowledgeable in packaging process development, appreciable understanding of materials
science
具有较强的良好人际关系技巧、沟通技巧和影响力
Highly effective interpersonal, communication and influencing skills
良好的问题解决能力
Good trouble shooting capability
较强的学习能力
High degree of learning agility
良好的中英文写作和沟通技巧
Good written and communication skill in both English and Chinese
能够熟练使用电脑
Good Computer skill, eg. Microsoft Office， Microsoft Project
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.