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:

大专及以上学历。

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

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

N/A

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

     

JOB FAMILY:

Manufacturing

     

DIVISION:

EPD Established Pharma

        

LOCATION:

China > Shanghai : EPO Plant

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable