Job Responsibilities 工作职责
1. Responsible for preparation and revision of the MPI, batch production records, risk assessments, revalidation, APS and reports.
负责工艺规程、批生产记录、风险评估、再验证方案、APS方案、报告的编制、修订；
2. Responsible for GMP knowledge training for personnel of the department, and improve the GMP management level of the post operators.
负责本部门人员GMP相关知识培训工作，提高岗位操作人员的GMP管理水平；
3. Responsible for the quality event(s) investigation, and generate related preventative action(s).
负责对质量事件进行调查，并制定相应的预防措施。
4. Prevent and correct potential quality risks discovered in time, investigate deviations in the production process, follow up the completion of quality events.
对发现的潜在质量风险及时的预防并纠偏，对生产过程偏差进行调查，跟进质量事件完成进度；
5. As a person of contact of the project(s) on behalf of department, participate the technical communication and track the daily production activities status.
代表部门作为项目对接人，参与项目技术交流，负责项目生产活动的日常状态跟进。
6. Author documents for drug product manufacturing processes.
编制成品药生产流程文件。
7. Participate in the internal/ external auditing program as required.
按要求参加内部/外部审计活动。
8. Author documents for the process validation, equipment (re-)qualification.
编制工艺验证，设备（再）确认的文件。
9. Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
为QA提供有关GMP设施问题的意见，并对环境监测和验证计划进行监督。
10. Review documentation and check all calculations (eg batch records, labels equipment readings).
审核文档并检查所有计算（例如批记录、标签设备读数）。
11. Escalate process issues as necessary to ensure resolution.
必要时升级流程问题以确保解决问题。
12. Ensure all work is performed in a safe manner and meets the specifications for each service request.
确保所有工作都以安全的方式执行，并符合各项服务需求规范。
13. Apply proper PPE (Personal Protective Equipment) to all work in the facility.
在工厂的所有工作中使用适当的PPE（个人防护设备）。
14. Complete other tasks assigned by supervisors.
完成上级领导安排的其他任务。

Qualification 任职资格
1. Bachelor's Degree in Chemistry, Chemical Engineering, Life Sciences or relevant background.
本科学历，专业是化学，化学工程，生命科学等同等专业。
2. At least 2 years’ experience of biopharmaceutical technology.
至少2年生物制药经验。
3. Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.
具备对无菌生产工艺的技术理解，以及GMP生产、监管原则和要求等工作知识。
4. Experienced in aseptic drug product manufacturing and project management, preferably protein drug.
具备无菌成品药生产经验和项目管理经验，具备蛋白质药品生产经验者优先考虑。
5. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills. Communicate effectively and work professionally in a team environment.
能够撰写和总结工作报告。在团队中高效的沟通和专业地工作；
6. Familiarity of computer-based systems.
熟悉计算机操作。
7. Oral and written communication skills in English and Mandarin (Read, Write, Verbal).
有很好的英语和普通话口语和写作技能（阅读，写作，口语）。