Main responsibilities职责描述： Please indicate here the main job responsibilities请列举该职位的主要工作职责。 Generic 通用 1. Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing. 2. 不断提高无菌生产的法规符合性和质量保证水平，参与并推进赛诺菲制造体系的深度实施和部门的精益生产。 3. Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc. 4. 组织、协调、跟进和实施偏差、变更、验证、投诉以及总部标准差距分析。 5. To ensure the continuous process compliance improvement through the management of quality systems. 6. 通过质量体系的管理确保生产工艺合规的持续改进。 7. To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation. 8. 贯彻执行公司的质量方针和质量目标，确保无菌生产运营的质量合规性。 9. To ensure effectiveness of sterile production quality improvement programs/projects. 10. 确保无菌生产运营的质量改进计划或项目的有效性 KEY ACCOUNTABILITI关键职责 1. Organize, coordinate, track and execute sterile production related investigation of deviations, complaints and correction actions, keep close communication with quality to improve the investigation compliance level. 组织、协调、跟进和执行无菌生产相关偏差、投诉的调查及整改措施的落实情况，与质量部保持良好的沟通，不断提高调查的符合性水平。 2. Participate in and lead sterile production related changes, guarantee the change compliance through regulation understanding. 参与、领导无菌生产相关的变更，通过不断增进法规理解保证变更的符合性。 3. Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance. 有效管理偏差和OOS程序并监控整改和预防性整改措施的落实以预防不符合事件的重现。 4. Responsible for maintaining the sterile production validation system, promoting the effective implementation of the validation, and writing the validation report. 负责维护无菌生产验证体系，推进验证有效执行，撰写验证报告等。 5. Coordinate the validation execution of process, equipment, cleaning and execution according to the master plan. 协调并跟进部门相关的工艺、设备、清洁等验证工作，保证按照计划实施。 6. Monitor production environment, process, hygiene, facilities and personal behavior and make proposal for improvement, to make sure the activities comply with SOP requirements， 监督生产环境、工艺、卫生、设施、人员行为方式等，提出改善措施，确保生产活动符合SOP要求。 7. Lead and coordinate department resource to attend self-inspection, authorities’ inspection and global quality audit. 领导并协调部门资源，应对自检、药监部门的检查以及总部质量审计。 8. Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff. 建立并持续开展GMP培训以维护全体员工高水准的GMP意识。 9. Ensures quality risks are properly managed (identification, assessment, control, communication). 确保质量风险得到适当管理（识别、评估、控制和沟通） 。 10. Assure the correct handling of product recall and customer complaints. 保证正确处理产品召回和客户投诉。 11. Ensure effectiveness of gap analysis process. 保证差距分析流程的有效性。 12. Involve site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs. 参与工厂质量改善项目或计划（如合规计划，质量成熟度评估，数据完整性成熟度评估等），以确保项目/计划的有效性。 13. Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization. 参与工艺优化、设备改进和技术创新，持续提高产品收率和设备利用率，参与赛诺菲制造系统标准的贯彻落实，在HSE、精益生产等方面持续改进。 14. Other tasks temporarily assigned by department manager. 按时完成上级临时交办的或部门间合作的其他工作任务。

•至少药学或生物学相关专业大学本科及以上学历， 3~5年质量或无菌领域工作经验。必须具备制药或相关行业的质量体系的“质量或无菌”专业知识经验。 •Thorough understanding of manufacturing processes and aseptic processes 全面理解生产流程和无菌工艺 •Strong working knowledge of quality systems, regulatory requirements across multiple health authorities. 质量系统和各相关法规要求等方面具有工作经验。 •Fluent English both in written and verbal 熟练的英语口语与书写能力 •Good communication skills 良好的 沟通能力 •Able to burden pressure 能够耐受压力 •Brave to make decision 果敢决策