M&S-Head of Inspection PCU _Fill & Finish-Beijing

Job title职位名称 : Head of Inspection PCU _Fill & Finish • Location工作地点： Beijing北京   About the job工作职责 Main responsibilities职责描述： 1.         Assist dept. manager to coordination of Project, plan, Quality and engineering to organise production with right volume, right quality, right cost and on right time. Supervise production, human resources, facilities to ensure all activities comply with China GMP and Sanofi regulations. Keep continuously improvement in terms of safety, quality, cost, delivery, motivation and environment. 协助部门经理有效协调项目、计划、质量、工程等资源，按时保质保量地组织生产。有效监控生产活动、人员、设备设施确保所有生产活动和过程符合中国GMP和赛诺菲内部规范的要求，推动安全、质量、成本、生产任务的达成、激励和环境方面的改善。 2.         Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing. 3.         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。 4.         Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc. 5.         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。 6.         To ensure the continuous process compliance improvement through the management of quality systems. 7.         通过质量体系的管理确保生产工艺合规的持续改进。 8.         To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation. 9.         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。 10.       To ensure effectiveness of sterile production quality improvement programs/projects. 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.         Perform the job duties of the Inspection Process-Centric Unit Lead. 履行灯检PCU负责人的工作职责 -Takes responsibility for the 24h performance of the Level 1 Operating Unit and defines priorities for the day/week/month. 负责1级操作层面的24h绩效，并制定日常日/周/月的工作优先级。 -Ensure that standards of SMS2.0 are followed (incl. Role cards, standard workplan, planning adherence, standard times, Asset Care activities. 确保遵循 SMS2.0 的标准（包括角色卡、标准工作计划、计划遵守情况、标准时间、资产维护活动。 -Make sure that improvements opportunities on the assets/processes/scheduling are correctly escalated and contribute to CI. 确保资产/工艺/计划上的改进机会并正确上报，并为 持续改进做出贡献。 -Attend to and lead Level 1 and Level 2 meetings (+QDCI Level 1 and Level 2, CI Level 1 and Level 2, Asset care, Deviation management, E2E flow...). 参加并领导 1 级和 2 级会议（+QDCI 1 级和 2 级、CI 1 级和 2 级、资产维护、偏差管理、E2E 流程...... -Reviews performance and contributes to upskilling PCU members. 审查绩效并有助于提高 PCU 成员的技能。 2.         Responsible for the shift work of PCU production (morning, middle and night). 负责PCU生产现场倒班（早、中、夜）工作。 3.         Actively participate in product transfer project, including training and related validation execution etc. 积极参与无菌生产项目的产品转移，包括培训和相关验证工作执行。 4.         Optimize the production process, improve the equipment and system, consistently supply high quality production for commercial operation preparation 优化生产工艺，改进设备和系统，保证始终如一地生产出合格产品，为正式商业运作的准备。 5.         Sustainably improve yield of compounding, filling and inspection equipment and ensure the stable supply to the market. 持续提高配制工艺收率，保证市场稳定供应。 6.         Management of the production environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements. 生产环境、工艺、卫生、设施等的管理，确保生产活动符合工艺规程、SOP和GMP要求。 7.         To review the batch production records and submit to Quality in time. 审核批生产记录，及时送交质量部门。 8.         To implement the equipment qualification, process validation according to the master plan. 按照计划执行完成区域内的设备的确认和工艺验证。 9.         To execute and follow the required initial and continuous trainings of production operators. 对生产相关人员进行必要的上岗前培训和继续培训，并根据实际需要调整培训内容。 10.       Organize daily production meeting, coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse etc., to implement production plan strictly and ensure right