大兴区
职位详情
工作内容CONTENT1. 审核批记录模板。Review the template of batch record.
2. 审核标准操作规程。Review SOP.
3. 承担客户审计相关事务。Responsible for customer audit related work
4. 审核并批准生产排程，确保各项作业具备生产实施条件。Review and approve the schedule of manufacturing. Ensure that all work conditions are in place
5. 编写与项目及生产相关的方案和报告。Draft protocols and reports related to project and production.
6. 负责生产过程中偏差的评估工作。Responsible for the evaluate the production deviations.
7. 主导客户投诉的调查，协调后续纠正与预防措施的落实。Responsible for customer complaint investigation. Coordinate subsequent CAPA completion
8. 提供生产车间的技术支持服务。Responsible for technical support of production workshop.
9. 负责车间的生产运作管理及人员调配。Responsible for workshop production management and personnel arrangement.
10. 协助培训管理员开展相关的培训任务。Assist the training administrator in related training work
11. 审核全部批次生产和包装记录，确保所有参与人员经指定人员审核后提交至质量管理部门。Review all production batch records and ensure that all participants are reviewed by designated personnel and sent to quality management.
12. 作为制剂生产中心五号车间负责人，全面负责五号车间的各项管理工作。The Workshop Manager of Production Workshop 5 in the DP Center is responsible for managing all matters of Production Workshop 5.
13. 完成上级交办的其他工作任务。Execute other related tasks.
教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION
1. 药物制剂、制药工程或相关专业大专及以上学历。College degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors.
2. 具备五年以上药品生产质量管理经验，其中至少三年从事注射剂类产品的质量管理。At least five years of work experience in pharmaceutical production quality management, including no less than three years of experience in quality management for injection productio.
3. 掌握无菌药品GMP法规要求，了解无菌保障相关专业技术知识。Familiar with GMP regulations for aseptic drug production and specialized knowledge of aseptic assurance.
4. 熟知注射剂生产工艺流程、标准操作程序、质量控制关键点，熟悉核心设备的操作性能与运行要求。Be familiar with the technological process, SOPs and quality control points of injection products, and master the performance and operation of key equipment.
5. 具备工艺问题分析、方案设计、判断决策、实际操作以及团队沟通协作能力。Have ability to analyze process problems, design protocols, judge, operate and communicate with others.
6. 拥有管理10人以上团队的实际经验。Having management experience of a team of more than 10 people.
7. 能够独立分析并解决产品生产工艺中的技术难题。Have ability to solve process problems independently.
8. 熟练操作常用办公软件。Familiar with computer documentation operation.
2. 审核标准操作规程。Review SOP.
3. 承担客户审计相关事务。Responsible for customer audit related work
4. 审核并批准生产排程，确保各项作业具备生产实施条件。Review and approve the schedule of manufacturing. Ensure that all work conditions are in place
5. 编写与项目及生产相关的方案和报告。Draft protocols and reports related to project and production.
6. 负责生产过程中偏差的评估工作。Responsible for the evaluate the production deviations.
7. 主导客户投诉的调查，协调后续纠正与预防措施的落实。Responsible for customer complaint investigation. Coordinate subsequent CAPA completion
8. 提供生产车间的技术支持服务。Responsible for technical support of production workshop.
9. 负责车间的生产运作管理及人员调配。Responsible for workshop production management and personnel arrangement.
10. 协助培训管理员开展相关的培训任务。Assist the training administrator in related training work
11. 审核全部批次生产和包装记录，确保所有参与人员经指定人员审核后提交至质量管理部门。Review all production batch records and ensure that all participants are reviewed by designated personnel and sent to quality management.
12. 作为制剂生产中心五号车间负责人，全面负责五号车间的各项管理工作。The Workshop Manager of Production Workshop 5 in the DP Center is responsible for managing all matters of Production Workshop 5.
13. 完成上级交办的其他工作任务。Execute other related tasks.
教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION
1. 药物制剂、制药工程或相关专业大专及以上学历。College degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors.
2. 具备五年以上药品生产质量管理经验，其中至少三年从事注射剂类产品的质量管理。At least five years of work experience in pharmaceutical production quality management, including no less than three years of experience in quality management for injection productio.
3. 掌握无菌药品GMP法规要求，了解无菌保障相关专业技术知识。Familiar with GMP regulations for aseptic drug production and specialized knowledge of aseptic assurance.
4. 熟知注射剂生产工艺流程、标准操作程序、质量控制关键点，熟悉核心设备的操作性能与运行要求。Be familiar with the technological process, SOPs and quality control points of injection products, and master the performance and operation of key equipment.
5. 具备工艺问题分析、方案设计、判断决策、实际操作以及团队沟通协作能力。Have ability to analyze process problems, design protocols, judge, operate and communicate with others.
6. 拥有管理10人以上团队的实际经验。Having management experience of a team of more than 10 people.
7. 能够独立分析并解决产品生产工艺中的技术难题。Have ability to solve process problems independently.
8. 熟练操作常用办公软件。Familiar with computer documentation operation.
2026-07-11 13:27
IP属地：北京
职位福利
大专5-10年
康龙化成(北京)新药技术股份有限公司
工作地址
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