按这个岗位的城市和方向提醒，确认后才开启，可选择每日或每周。
核心工作职责:Core Job Responsibilities:
一、技能操作
制粒Granulation
Operate strictly as SOP and MO/MD.
Properly carry out line clearance. Before production, carefully check raw materials as MO.
Properly carry out in-process checks such as granule appearance and LOD to ensure product quality.
Properly use and well maintain granulation machines. Stop and well handle machine immediately in case of abnormity.
Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.
Clean the production area and equipment for granulation process as related SOP.
压片Compression
Operate strictly as SOP and MD.
Properly carry out line clearance. Before production, carefully check blended granule as MD.
Properly carry out in-process checks such as tablet appearance, weight and hardness to ensure product quality.
Properly set-up, use and well maintain compression machines. Stop and well handle machine immediately in case of abnormity.
Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.
Clean the production area and equipment for compression process as related SOP.
包衣 （包衣液配制 / 包衣）Coating solution/coating
Operate strictly as SOP and MO/MD.
Properly carry out line clearance. Before production, carefully check raw materials/intermediate as MO/MD.
Properly carry out in-process checks such as coated-tablet appearance to ensure product quality.
Properly use and well maintain coating machines. Stop and well handle machine immediately in case of abnormity.
Fill out process record accurately and punctually. Properly tag status of area machine and material as SOP.
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：
Responsible for uploading department files to the Darius system
Maintain files in the Darius system
Responsible for updating the paper documents to ensure that they are the current version when the document is upgraded
文件document：
Update and initiate to finish processing procedure for all kinds of products.
Initiate to draft or revise PTD/SOP.
Assist production department to make and correct MO/MD, FO/FD and other technical documents.
Review the batch records and other kinds of production statistics.
Check the production record periodically and sign on it, and carry out correction plan.
Archive, maintain, update, and issue department file systems.
GMP：
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.
Assist production department to do GMP self-inspection periodically.
验证Validation:
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
N/AIn specific locations, the pay range may vary from the range posted.
