制剂生产分厂负责人

负责制剂生产部门生产活动Responsible for XDP manufacturing activities.为满足客户的需求，能充分利用资源，协调与组织所在区域生产有序进行。To meet customer needs, make full use of resources, coordinate and organize production in the region.确保生产过程中各环节符合国内外GMP要求，按标准操作程序执行，使产品质量得到有效保证。Ensure the production process in accordance with GMP

in domestic and foreign, according to the standard operating procedures, so that the quality of products can be effectively guaranteed.管理属下员工有效进行日常的设备使用、清洁、维护与模具更换工作，使设备处于有效运行与管理之中。Manage the daily equipment use, cleaning, self-maintenance and mold change to keep the equipment in effective operation and management.对工艺、设备、方法等进行不断的改进与完善以进一步提高生产效率、稳定产品质量，满足不断的发展需求。Constantly improve and perfect the process, equipment, methods and other to further improve the production efficiency and stabilize the quality of products and meet the continuous development needs.监督所在区域人员严格按照规程及工艺进行操作。Supervise the area personnel to operate strictly according to the procedures and processes.为保证生产的安全进行，保证生产现场清洁卫生，制定相应的管理措施，指导及监督员工遵守执行。To ensure the safety of production, ensure the cleanliness of the production site, formulate the corresponding management measures, guide and supervise the staff to comply with the implementation.负责制剂生产部门GMP质量管理类活动Responsible for XDP GMP quality management activities.负责起草和审批 XDP部门cGMP 文件，如技术报告、SOPs、生产批记录、风险评估报告等规范性文件。Be responsible for the preparing and approving of cGMP documents, such as technical report, SOPs, BPRs and risk assessment report in XDP.负责XDP相关的审计、自检、投诉、召回及偏差、变更、CAPA的审批等。Be responsible for the audit, internal audit, complaints, product recall and deviation, change control, CAPA approval, etc. in XDP.确保完成各种必要的确认或验证工作，审核和批准确认或验证方案和报告。To ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports.负责制剂生产部门运营管理类活动Responsible for XDP operation management activities.能根据所负责区域的工艺技术要求，具备组建团队能力。Ability to build a team according to the technical requirements of the responsible area.为确保员工上岗前进行合适的培训，制定培训规程及计划，并通过合适的程序保证员工得到有效的培训，发展员工技能，做好所在区域人员储备。In order to ensure proper training for employees before starting work, develop training procedures and plans,ensure effective training for employees through appropriate procedures, develop staff skills, and make staff reserves in the area.为保证新产品、新设备与新工艺在生产过程中的顺利实施，组织相关员工参与新工艺；新设备的调研、安装与调试，协调制定相关操作规程，并有效培训员工，使之能顺利进行。To ensure the smooth implementation of new products, new equipment and new process, organize relevant employees to participate in the new process.Investigate, install and debug new equipment, coordinate to develop related operating procedures, and effectively train staff to make it go on smoothly.为维护良好的生产秩序，保证生产正常运行，贯彻相关的员工守则，对员工的表现进行考核等有效管理。In order to maintain a good production order, ensure the normal operation of production, implement the relevant employee rules, conduct performance assessment and other effective management of employees.负责WBS工作，如DM，PSP，Kaizen改善等。Be responsible for the WBS initiatives, such as DM, PSP Kaizen, etc.新项目支持New Project Support负责为新厂房建设培养生产人才Responsible for training production personnel for new factory负责为新设备引入提供技术和人员支持Responsible for providing technical and personnel support for new equipment introduction药物制剂、药学、生物工程/化工等相关专业本科及以上学历。Bachelor or above degree in Pharmaceutical Preparation, Pharmacy, Bioengineering/Chemical Engineering or other majors, as appropriate本科需5年以上类似工作经验，硕士需3年以上类似工作经验；管理经验3年及以上。Minimum 5+ years experience in similar position for bachelor degree and 3+ years experience in similar position for master degree, 3+ years in management role.熟悉FDA/中国/欧盟法规及ICH等的要求Familiar with FDA/China/EU and ICH GMP requirements熟悉无菌制剂专业知识，熟悉无菌药品生产，熟悉质量体系 Familiar with aseptic preparations, familiar with sterile pharmaceutical production and quality system熟悉单抗等大分子生产，有ADC药物生产经验优先Familiar with macromolecule production such as monoclonal antibody, experience in ADC drug production is preferred较强的英语听说读写能力 English skills in listening, speaking, reading and writing熟练使用计算机,会操作OFFICE办公软件 Proficient in computer use, able to operate OFFICE software良好的沟通协作能力Good communication and coordination skills