主要职责Major Responsibilities:
EPD-SHA-PR-M002生产主管 Supervisor Responsibilities:
o 根据物流部签发的生产计划，协助部门制订详细进程的批生产计划安排，并以此进行生产组织和人员调配。
Assist production department to prepare detailed batch plan based on production plan issued by Logistics Dept., and make necessary arrangement in advance.
o 协助部门对生产现场进行监督管理；负责生产过程的SOP实施与符合。
Take responsibility of on-site management and GMP compliance.
o 符合GMP的前提下，不断提高，改进，完善生产技术文件系统，改进生产操作，提高产品质量和生产效率。
With GMP compliance, improve product documents　and operation continuously to improve product quality and productivity.
o 参与和制订生产部有关的管理制度、文件等。
Take part in making and correcting management system and documents related with production department.
o 按规定日期向部门主管/经理提交工作报告。
Hand in monthly report timely.
o 执行和完成部门主管/生产经理指派的其他工作。
Carry out and finish other work assigned by Production supervisor/Production manager

EPD-SHA-QA-M017文件协调员EPD-SHA-QA-M017 Document Coordinator：
o 负责将部门文件上传至Darius系统
Responsible for uploading department files to the Darius system
o 维护Darius系统内文件
Maintain files in the Darius system
o 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
EPD-SHA-QA-M018制定培训计划、实施培训 EPD-SHA-QA-M018 Training Coordinator：
o 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.
o 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.
其他职责 Other responsibilities
文件document：
o 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.
o 协助部门制订或修改MMF/SOP。
Initiate to draft or revise MMF/SOP.
o 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.
o 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.
o 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.
o 归档，维护，更新和发放部门文件系统。
Archive, maintain, update, and issue department file systems.
EHS：
o 协助部门完成EHS文件及相关的工作。
Assist to do EHS document and related work.
o 做好部门的安检工作。
Take care of safe inspection in department.
o 负责监督生产部操作人员现场的操作时符合EHS的要求。
Supervise on-site operations to be line with the company and corporate EHS policies and requirements
GMP：
o 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.
o 配合部门定期做好GMP自检。
Assist production department to do GMP self-inspection periodically.
验证Validation:
o 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.
异常情况：
o 及时向生产经理如实汇报制造和包装或管理过程中的各项不符合。
Truthfully report to the Production manager the non-conformance during manufacturing and finish process or manage area in time.
o 及时完成调查和异常报告。
Finish Investigation and Exception Report in time with production foreman or line lea备注：
生产经理委托的工作 Works delegated by Production Manager：
o 按照已批准的程序对产品批记录复核。
Review Batch Record for finish products according to approved procedure.
o 相关程序文件和报告的批准
Approve relative procedures and reports
学历要求：Minimum Education:
至少具有药学或相关专业本科学历
Must, at a minimum, have an educational qualification of an undergraduate course in pharmacy or related sciences
工作经验/培训要求：Minimum Experience/Training Required:
至少 一年从事食品或药品生产和质量管理的实践经验。
At least three-years practical experience in management of drug production and quality.
能够阅读相关的英文资料。
Be able to read related English materials.