Operator

**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/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