北京招聘

职位描述：
Key accountabilities:
1. Ensure the all the production activities comply with the cGMP and other regulatory standards, all the operations are fully follow the procedure to ensure the product quality can fulfill the marketing requirements;
确保生产过程中各环节符合国家GMP及相关法规要求，保证所有生产流程按照既定程序进行,满足市场对产品产量的需求，使产品质量得到有效保证
2. Maintain a safety work environment, Identify EHS risks by performing inspection, risk assessment and internal audit, work out the actions to reduce the risks;
维护良好的安全生产环境，通过自查、风险分析、内部审计的方式找出EHS隐患并制定改善计划
3. Lead the lean & 6S project. Setup standard working hour, calculate the capacity and labor load, OEE data analysis and improvement;
主导展开精益生产、6S，负责标准工时、标准产能、标准人力配置等，提升线OEE；
4. Process, procedure and equipment assessment and optimization;
评估工艺、流程、设备合理性及适用性，提交改进、优化方案并主导实施；
5. Participate in the wuxi site project such as review the workshop layout and line setup;
参与无锡工厂项目施工过程，审核车间平面布局图及生产线Layout；
6. Write the technical documents such as SOPs, Forms and URS;
负责生产车间及部门内标准操作规程（SOP）、记录表格及URS的编写；
7. Prepare the qualification and validation document and execution;
编写产品验证文件，完成相应的产品验证工作；
8. Trained and train of the process, include but not limited to production system, procedure, and equipment operation;
接受并实施产品培训，包括并不限于生产体系、流程、设备操作等；
9. Assist supervisor to draw up budgets within responsible scope.
协助上级制定所辖责任范围内的费用预算。
10. Deviation investigation, complaint report and CAPA actions;
偏差、投诉调查、CAPA
11. Other tasks assigned by supervisor.
完成上级领导临时交给的其它工作任务。

Requirements:
1. Education/Experience: College or above, major in pharmaceutical, chemical or engineering related. At least 3 years’ experience in pharmaceutical industry, have IE experience is highly preferred.
教育程度/经验：制药、化学或工程等相关专业本科以上或3年以上相关工作经验，拥有工业工程相关经验优先
2. Have experience in equipment C&Q, PV, CV, especially in CSV;
对于设备调试及确认、工艺验证、清洁验证有一定了解，特别是计算机系统验证；
3. Hands on experience in IE, 6S, OEE to improve the production efficiency
工业工程、6S、OEE等方面有实际项目经验，帮助提升生产效率
4. Good communication skill; self-motivated; teamwork;
具备良好的沟通、表达能力；自我激励；良好的团队合作意识；。
5. 团队合作：对部门人员和各职位的工作内容有清晰的认识， 能与其他同事协同工作，具备团队意识及合作的精神。
6. Communicate effectively in both verbal and written in English.
具备英文书面和口头交流的能力。 举报 分享

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。