Position Description/职位描述
1. Responsible for aseptic product production site management, on-time completion of product production tasks, to ensure that the product meets the quality standards.
负责无菌产品生产现场管理，按时完成产品生产任务，确保产品符合质量标准。
2. Responsible for equipment qualification, process validation and cleaning validation in production department scope, including protocol drafting, qualification/validation executing, and report summarizing.
负责生产部门范围内的设备确认、产品工艺验证和清洁验证，包括方案编写、确认/验证执行和报告总结。
3. Responsible for SOPs/BPRs drafting and revising in production department scope, responsible for staff training.
负责编写和修订生产部门范围内的SOP和BPR，负责员工培训工作。
4. Responsible for proceeding and following up on deviations, changes and CAPAs related to the production department.
负责处理和跟进与生产部门有关的偏差、变更和CAPA。
5. Responsible for safety management on production site, preventing accidents and reporting safety risks and near miss events in a timely manner.
负责生产现场的安全管理，防止安全事故发生，及时报告安全风险和安全隐患。
6. Complete other tasks as assigned by the superiors.
完成上级指派的其他任务。

Requirements/招聘要求
1. Bachelor's degree with a major in pharmaceuticals and other related fields, 3+ years’ experience in aseptic manufacturing. 2+ years’ experience in people management.
本科学历，主修制药或其他相关专业，3年以上无菌制剂生产工作经验，2年以上的团队管理经验。
2. Familiar with protocol preparing and implementing of sterile-related equipment qualification, process validation and cleaning validation.
熟悉无菌制剂生产相关的设备确认、产品工艺验证和清洁验证的方案编写和执行。
3. Experience with risk evaluation for aseptic manufacturing processes by common tools and methods (RRF, FMEA, etc.).
能运用常用的风险评估工具和方法（RRF、FMEA 等）对无菌生产环节进行风险评估。
4. Proficiency in Microsoft office software, Familiar with manufacturing process of sterile liquid injections, experience in GMP related documents drafting/revising/training.
熟练掌握微软办公软件，熟悉无菌液体注射剂的生产流程，具有编写/修订/培训GMP相关文件的经验。
5. Familiar with the processes and requirements for quality system elements such as deviations, changes and CAPAs in the pharmaceutical industry. Experience in deviation investigations and change control implementation.
熟悉制药行业质量体系要素（如偏差、变更和CAPA）的流程和要求。具有偏差调查和变更控制实施方面的经验。
6. High level of awareness of production safety and GMP aseptic behavior.
具备高度的安全生产和GMP无菌行为意识。
7. Minimum of CET-4 certificate and able to work overtime.
通过CET-4或以上英语等级考试，能接受加班。