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.