大兴区
职位详情
工作内容CONTENT1. 审核模板类批记录。Review of Template Approval Records
2. 审核标准操作规程。Review of SOP
3. 承担客户审计相关事务。Be responsible for the client audit-related work.
4. 审核并批准生产计划，确保各项任务满足生产准备条件。Review and approve the production plan. Ensure that all tasks are ready for production.
5. 编制与项目及生产相关的方案和报告。Draft project and production-related plans and reports
6. 负责生产偏差的评估工作。Responsible for evaluating production deviations.
7. 主导客户投诉的调查，协调后续纠正与预防措施的实施。Be responsible for the investigation of customer complaints and coordinate the completion of subsequent CAPA.
8. 检查生产过程中工艺执行情况，并签发清场合格证（正本与副本）。Be responsible for inspecting the execution of processes during the production process and issuing the "cleaning qualification certificate" (both the original and the duplicate) for cleaning.
9. 确保生产设备环境清洁，必要时进行消毒处理。Ensure that the production facilities are clean and disinfect them when necessary.
10. 协助开展培训管理员所辖的培训任务。Assist in the training work of the training administrator.
11. 审核全部批次生产和包装记录，确认相关人员经指定人员审核后移交质管部门。Review all batch production and batch packaging records, ensuring that all relevant personnel have been reviewed by designated personnel and submitted to the quality management department.
12. 完成其他交办的相关事项。Complete other related tasks.
教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION
1. 药物制剂、制药工程或相近专业本科及以上学历。Bachelor's degree or higher in pharmaceutical preparations, pharmaceutical engineering or a related field.
2. 五年以上口服固体制剂商业化生产管理经历，掌握MES、SCADA等数字化系统应用，具备OEB4或更高防护等级高活性口服固体制剂的生产管理经验。At least 5 years of experience in commercial production management of oral solid preparations. Familiar with digital systems such as MES and SCADA, and have production management experience for high-active oral solid products of OEB4 or above.
3. 熟知药品监管法规，包括《中华人民共和国药品管理法》及GMP相关规定。Understand relevant pharmaceutical regulations, such as the " Drug Administration Law of the People’s Republic of China " and GMP regulations.
4. 精通口服固体制剂生产工艺流程、标准操作程序、质量控制关键点，熟悉核心设备的技术性能与操作规范。Be familiar with the oral solid production process, SOPs, quality control points, and master the performance and operation of key equipment.
5. 具备工艺问题分析、解决方案设计、判断决策、实操执行及团队沟通协作能力。Possess the ability to analyze process issues, design solutions, make judgments, perform operations, and communicate with others.
6. 具备组织与推动生产管理工作的能力。Have the ability for production management.
7. 能够独立应对和解决产品工艺过程中的技术难题。Has the ability to independently solve product manufacturing problems.
8. 具备英文交流能力，熟练操作常用办公软件。Have the ability to communicate in English and be familiar with computer document operations.
2. 审核标准操作规程。Review of SOP
3. 承担客户审计相关事务。Be responsible for the client audit-related work.
4. 审核并批准生产计划，确保各项任务满足生产准备条件。Review and approve the production plan. Ensure that all tasks are ready for production.
5. 编制与项目及生产相关的方案和报告。Draft project and production-related plans and reports
6. 负责生产偏差的评估工作。Responsible for evaluating production deviations.
7. 主导客户投诉的调查，协调后续纠正与预防措施的实施。Be responsible for the investigation of customer complaints and coordinate the completion of subsequent CAPA.
8. 检查生产过程中工艺执行情况，并签发清场合格证（正本与副本）。Be responsible for inspecting the execution of processes during the production process and issuing the "cleaning qualification certificate" (both the original and the duplicate) for cleaning.
9. 确保生产设备环境清洁，必要时进行消毒处理。Ensure that the production facilities are clean and disinfect them when necessary.
10. 协助开展培训管理员所辖的培训任务。Assist in the training work of the training administrator.
11. 审核全部批次生产和包装记录，确认相关人员经指定人员审核后移交质管部门。Review all batch production and batch packaging records, ensuring that all relevant personnel have been reviewed by designated personnel and submitted to the quality management department.
12. 完成其他交办的相关事项。Complete other related tasks.
教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION
1. 药物制剂、制药工程或相近专业本科及以上学历。Bachelor's degree or higher in pharmaceutical preparations, pharmaceutical engineering or a related field.
2. 五年以上口服固体制剂商业化生产管理经历，掌握MES、SCADA等数字化系统应用，具备OEB4或更高防护等级高活性口服固体制剂的生产管理经验。At least 5 years of experience in commercial production management of oral solid preparations. Familiar with digital systems such as MES and SCADA, and have production management experience for high-active oral solid products of OEB4 or above.
3. 熟知药品监管法规，包括《中华人民共和国药品管理法》及GMP相关规定。Understand relevant pharmaceutical regulations, such as the " Drug Administration Law of the People’s Republic of China " and GMP regulations.
4. 精通口服固体制剂生产工艺流程、标准操作程序、质量控制关键点，熟悉核心设备的技术性能与操作规范。Be familiar with the oral solid production process, SOPs, quality control points, and master the performance and operation of key equipment.
5. 具备工艺问题分析、解决方案设计、判断决策、实操执行及团队沟通协作能力。Possess the ability to analyze process issues, design solutions, make judgments, perform operations, and communicate with others.
6. 具备组织与推动生产管理工作的能力。Have the ability for production management.
7. 能够独立应对和解决产品工艺过程中的技术难题。Has the ability to independently solve product manufacturing problems.
8. 具备英文交流能力，熟练操作常用办公软件。Have the ability to communicate in English and be familiar with computer document operations.
2026-07-21 13:22
IP属地：北京
职位福利
本科5-10年质量管理生产计划管理现场管理
康龙化成(北京)新药技术股份有限公司
工作地址
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