DP Filling Engineer

Found in: Talent CN S2 - 7 days ago

Guangzhou Shi, China BeiGene Full time

Job Description:

1. Assist the management of document system and quality
协助车间文件体系和质量管理
Assist filling leader to establish the document system.
协助灌装负责人领导下，协助灌装车间的文件体系的建立。
Assist draft the process description, batch record and SOP/WI.
协助车间工艺规程、批生产记录、操作程序等技术性文件的编写及审核。
Assist execute the qualification of utility and equipment and PV.
协助完成厂房设施确认、设备确认、工艺验证。

2. Filling manufacturing
灌装生产
Execute the production according to plan.
根据车间下达的生产计划，保质保量、按时按量完成灌装任务。
Assist the staff training and ensure operation compliance with SOP/WI. And record the GMP form on time with good GDP.
协助灌装人员的文件和安全培训，督促人员按照SOP进行操作，并正确填写各类GMP文件记录，对违反GMP和SOP 的操作行为进行指正。
Assist the cost control and establish the list of materials.
负责灌装物料的使用管理，避免物料的不合理使用及浪费，以降低生产成本。
Assist improve the filling efficiency.
协助负责人或技术人员对灌装工序进行工艺技术改进，提高产品质量和收率。
Support to deviation investigation, change control and CAPA follow up.
协助偏差调查、变更控制和CAPA处理。

3. EHS
Comply with EHS regulations to ensure safe and civilized production.
遵守EHS的各项规定，确保安全文明生产。

4. Others其它
Any other assignment as is determined by supervisor.
完成上级安排的其它工作。
 

Qualification Required:

Academic/ Professional Qualification
学历/专业资格
Junior college or above in Pharmacy, Chemistry, Microbiology or related major.
药学、化学、微生物学或相关学科大专或以上学历。
Technical/Skills Require
技术/技能训练
With aseptic filling skills and good aseptic consciousness.
无菌分装技能，良好无菌意识。
Familiar with regulations and principle of GMP.
熟悉GMP法规及指导原则。
Working Experience
工作经验 
Above 3 years’ experience in pharmacy company.
3年以上制药行业工作经验。
Above 1 years’ filling experience.
至少1年无菌注射剂生产工作经验。
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
Good English in written. Good office software skills.
英语良好，熟悉电脑办公软件。
Others其他 
Positive, dedicated, Progressive, Responsibility and Integrity.
积极敬业、主动进取、责任心强、正直向上。
Some ability in decision-making.
具有一定的判断和决策能力。
Good communication.
具有良好的合作精神。

Obey the arrangement.
服从领导安排。
 

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

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