About this role
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 N/AIn 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