完成口服固体制剂生产区域的工作。具备持续改进的意识，以提高个人与团队能力为目标。

Complete work in OSD production area. Have continuous improvement awareness.Have the goal of improving individual and team capabilities.

具有良好的职业道德、敬业精神及团队协作精神，工作积极主动、责任心强。

Have good professional ethics, professionalism and teamwork spirit, work actively and have a

strong sense of responsibility.

1. 一般要求

General requirement

? 积极参与OSD车间的日常工作。

Actively participate in the daily work of OSD workshop.

? 按生产计划保质保量完成生产任务；
遵循GMP 规范的要求保证产品质量。

Finish the production task according to the production plan to ensure the quality and quantity; Follow GMP specification to ensure product quality.

? 负责固体制剂区域和设备的操作和清洁，确保所用设备保持清洁和完好。

Responsible for the operation and cleaning of the OSD equipment to ensure that the equipment is kept clean and in good condition.

? 遵守公司规章制度和GMP要求,并及时报告与GMP相背离的现象。

Comply with company regulations and GMP requirements and report any deviation ｆｒｏｍ　GMP.

? 遵循EHS 规范符合环境保护,员工职业保护和生产安全。

In accordance with EHS regulations to comply with environmental protection, employee occupational protection and production safety.

? 按照SOP要求及时准确地填写生产记录。

Fill in the production record timely and accurately according to SOP.

? 提出有建设性的建议并参与提高质量，效率，成本以及安全的项目。

Make constructive suggestions and participate in projects to improve quality, efficiency, cost and safety.

? 具有良好的安全意识和行为，以避免安全事故的发生。

Good safety awareness and behavior to avoid accidents.

? 服从主管安排的工作任务，包括培训等。

Obey the task assigned by supervisor, including training, etc.

? 当任何违反公司政策、目标或要求的情况发生时要第一时间通知主管。

Inform supervisor immediately of any violation of company policy, objectives and requirements.



2. 主要负责的产品技术工作：

Mainly responsible for product technology:

1) 负责相关验证工作，包括工艺验证的管理，设备的再确认等

Responsible for relevant validation work, including process validation management, equipment reconfirmation, etc

2) 负责设备计算机化系统管理（包括年度回顾、概述、审计追踪、风险评估等）

Be responsible for equipment computerized system management (including annual review, overview,audit tracking, risk assessment, etc.)

3) 参与相关变更发起、评估、CAPA执行

Participate in relevant change initiation, evaluation and CAPA implementation

4) 参与相关偏差的发起、评估、调查、CAPA执行

Participate in the initiation, evaluation, investigation and CAPA implementation of relevant deviations



3、GMP相关工作：

GMP related work:

1) 负责生产SOP/WI/SPEC的起草和升版

Be responsible for drafting and upgrading sop/wi/spec of the production area

2) 负责生产内部偏差、变更、新文件的培训

Be responsible for the training of internal deviations,changes and new documents of the production area

3) 负责生产文档的管理，文件分发、回收、归档等

Responsible for production area document management, document distribution, recycling, archiving, etc

4) 负责生产设备/设施的计量

Be responsible for the measurement of production area equipment / facilities



4、 EHS相关工作：

1) 及时发现包装安全隐患并及时上报

Discover and report the potential safety hazards of the packaging area in time

2) 配合EHS部门完成相关法规检查

Cooperate with EHS department to complete relevant regulatory inspection

3) EHS相关CAPA及时完成并关闭

EHS related CAPA shall be completed and closed in time







ａｄｄitional Job Deｓｃｒｉｐｔion

? 大专以上学历，药学、机电或相关专业毕业

College degree or above, major in pharmacy, mechatronic or related

? 大专学历，制药行业3年的工作经历

3 years of working experience in pharmaceutical industry for Junior college graduate.

? 良好的GMP知识

Good knowledge of GMP

? 良好的制药生产知识

Good knowledge of pharmaceutical production

? 良好的EHS知识

Good knowledge of EHS

? 设备操作动手能力较强

Strong skill of operating equipment

? 普通话

Mandarin

? 较好的数据分析能力，能熟练操作使用包括Excel、Word，PowerPoint等软件的操作。

Good data analysis ability, skilled in the operation of software including excel, word, PowerPoint and so on.

? 具备良好的沟通协调、问题解决能力

Good communication, coordination and problem solving skills

专业要求：制药工程

上班地址：-江苏-苏州-苏州工业园区桑田街218号生物产业园6栋4楼