JOB DESCRIPTION:

核心工作职责:Core Job Responsibilities:

一、技能操作

制粒Granulation

• 严格按照标准操作规程和制造指令单/工艺操作规程进行制粒操作。

Operate strictly as SOP and MO/MD.

• 严格执行清场。生产前仔细按照制造指令单复核原辅料。

Properly carry out line clearance. Before production, carefully check raw materials as MO.

• 严格执行中控检查（颗粒外观、LOD等），确保产品质量。

Properly carry out in-process checks such as granule appearance and LOD to ensure product quality.

• 正确使用制粒工序相关设备，并保持设备处于良好状态，如有异常应立即停机处置。

Properly use and well maintain granulation machines. Stop and well handle machine immediately in case of abnormity.

• 制粒过程中及时准确填写生产记录，并按状态标志要求标记好区域、设备和物料的状态。

Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.

• 按照相关的SOP认真做好制粒设备和区域的清洁工作。

Clean the production area and equipment for granulation process as related SOP.

压片Compression

• 严格按照标准操作规程和工艺操作规程进行压片操作。

Operate strictly as SOP and MD.

• 严格执行清场。生产前仔细按照制造工艺操作规程复核总混后颗粒。

Properly carry out line clearance. Before production, carefully check blended granule as MD.

• 严格执行中控检查（片子外观、重量、硬度等），确保产品质量。

Properly carry out in-process checks such as tablet appearance, weight and hardness to ensure product quality.

• 正确安装和使用压片工序相关设备，并保持设备处于良好状态，如有异常应立即停机处置。

Properly set-up, use and well maintain compression machines. Stop and well handle machine immediately in case of abnormity.

• 压片过程中及时准确填写生产记录，并按状态标志要求标记好区域、设备和物料的状态。

Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.

• 按照相关的SOP认真做好压片设备和区域的清洁工作。

Clean the production area and equipment for compression process as related SOP.

包衣 （包衣液配制 / 包衣）Coating solution/coating

• 严格按照标准操作规程和制造指令单/工艺操作规程进行包衣液配制/包衣操作。

Operate strictly as SOP and MO/MD.

• 严格执行清场。生产前仔细按照制造指令单/工艺操作规程复核原辅料/中间体。

Properly carry out line clearance. Before production, carefully check raw materials/intermediate as MO/MD.

• 严格执行中控检查（包衣片外观等），确保产品质量。

Properly carry out in-process checks such as coated-tablet appearance to ensure product quality.

• 正确使用包衣工序相关设备，并保持设备处于良好状态，如有异常应立即停机处置。

Properly use and well maintain coating machines. Stop and well handle machine immediately in case of abnormity.

• 包衣液配制/包衣过程中及时准确填写生产记录，并按状态标志要求标记好区域、设备和物料的状态。

Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.

• 按照相关的SOP认真做好包衣液配制/包衣设备和区域的清洁工作。

Clean the production area and equipment for coating solution preparation / coating process as related SOP.

二、文件职责

培训协调 Training Coordination：

制订生产部员工GMP、技术操作、有关法律法规和EHS等方面的培训计划并负责有效实施。

Make a schedule for operators' training of GMP, MO/MD/FO/FD, regulars, policy and EHS etc., and be responsible for carrying it out effectively.

确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容。

To ensure that the required before-work training and continuing training of personnel related to production are carried out, and training content is adjusted according to real needs.

文件协调 Documentation Coordination：

• 负责将部门文件上传至Darius系统

Responsible for uploading department files to the Darius system

• 维护Darius系统内文件

Maintain files in the Darius system

• 文件升级时负责更新纸质文件确保为现行版

Responsible for updating the paper documents to ensure that they are the current version when the document is upgraded

文件document：

• 协助部门更新或制定产品的工艺规程。

Update and initiate to finish processing procedure for all kinds of products.

• 协助部门制订或修改PTD/SOP。

Initiate to draft or revise PTD/SOP.      

• 协助部门制订或修改MO/MD，FO/FD 及其他技术文件。

Assist production department to make and correct MO/MD, FO/FD and other technical documents.

• 准时完成生产批记录的审核及各类生产统计。

Review the batch records and other kinds of production statistics.

• 定期检查各类生产记录并签名，实施各项整改和改进措施。

Check the production record periodically and sign on it, and carry out correction plan.

• 归档，维护，更新和发放部门文件系统。

                      Archive, maintain, update, and issue department file systems.

GMP：

• 负责生产部的SOPs和制造文件，应符合GMP和总部方针的要求。

Be responsible for Production Related Standard Operating Procedure’s system, Manufacturing documentation system overall compliance, monitoring and maintaining according to both requirements of GMP and headquarters’ related policies.

• 配合部门定期做好GMP自检。

Assist production department to do GMP self-inspection periodically.

验证Validation:

• 协助部门完成验证文件及相关的工作。

Assist production department to do validation document and related job in production department.

管理职责：Supervisory/Management Responsibilities:

直接汇报：Direct Reports:   主管

最低学历要求：Minimum Education:

中专及以上学历

Associate degree or above.

最低工作经验/培训要求：Minimum Experience/Training Required:

掌握岗位安全操作规程，熟知GMP要求和洁净操作规定

Well know about position safety operation procedure.  Be familiar with GMP requirement and operation in cleaning area.

具有一定的制药工艺设备操作技能。

Certain pharmacy process equipment operation skill.

核心技能应至少具备2个（至少有制粒能力）

At least 2 ore skills should possessed

具有文件技能者优先选择

Those with file skills will be given priority

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: