DP 11-制剂生产工程师

专科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员。 Junior college degree (or above) with major in Biology, Chemistry or Pharmaceutical Engineering or related Science major or person with equivalent experiences. 熟悉注射剂生产设备的原理、会熟练操作设备。 Familiar with the principle of injection production equipment and skilled in operating equipment. 负责设备的日常维护并协助维修人员对设备进行检修及校验，验证。 Be responsible for the daily maintenance of the equipment and assist the maintenance personnel to repair, verify and verify the equipment. 负责进行水针剂型和冻干剂型生产过程中的清洗、灭菌、洗瓶等操作。 Be responsible for washing、sterilizing、bottle washing and other operations in the production process of injection dosage form. 负责按GMP要求进行器具准备、培养基/缓冲液配制等生产工艺操作。 Responsible for instrument preparation, media/buffer preparation and other process operation per GMP

. 有一定的无菌操作能力与意识。 Have certain aseptic operation ability and consciousness. 熟悉罐装机，轧盖机，冻干机，隔离器等无菌制剂设备的使用。Familiar with the use of sterile preparation equipment such as filling machine, capping machine, lyophilizer and isolator. 负责生产过程中批生产记录及设备使用台帐的填写。 Be responsible for filling in batch production records and equipment use account during production. 负责所在洁净区域的清洁，消毒。 Be responsible for the cleaning and disinfection of the clean area. 完成生产相关文件培训 Complete Manufacturing Related Documentation Training 生产过程中及日常行为严格遵守EHS、IP保护等合规准则。 Strictly abide by EHS, IP protection and other compliance standards in the production process and daily behavior.