KEY ACCOUNTABILITI关键职责 Lead continuous improvement work on sterile production APU&PCUs. APU&PCU持续改进工作。 Develops and owns the CI process (meetings, prioritization, coordination of project, escalation, KPI update and data analysis). 制定并负责 CI 流程（会议、优先级、项目协调、升级、KPI 更新和数据分析） Leads CI development of the team (role cards and standard work plan, root cause analysis and problem solving, development of Asset Care standards). 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. Participate in and lead sterile production related changes, guarantee the change compliance through regulation understanding. Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff. GMP培训以维护全体员工高水准的GMP意识。 Be familiar and enhance global standards understanding, lead sterile production related gap analysis and implementation. Coordinate the validation execution of process, equipment, cleaning and execution according to the master plan. Monitor production environment, process, hygiene, facilities and personal behaviour and make proposal for improvement, to make sure the activities comply with SOP requirements， SOP要求。 Lead and coordinate department resource to attend self-inspection, authorities’ inspection and global quality audit. 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. 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。 Ensures quality risks are properly managed (identification, assessment, control, communication). 。 Assure the correct handling of product recall and customer complaints. Ensure effectiveness of gap analysis process. Involve site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs. /计划的有效性。 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. HSE、精益生产等方面持续改进。 Other tasks temporarily assigned by department manager. Sterile production Department HSE Responsibilities 无菌生产部HSE职责 ➤ Responsible for following the company’s HSE policy and integrated all requires into daily job. 负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。 ➤Incorporate HSE work into the work plan 将HSE工作纳入工作计划中。 ➤ Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan. 组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。 ➤Regularly carry out to identify HSE potential hazards and develop action plan and finish on time. 定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。 ➤Timely working out of employee opinions. 负责部门级HSE教育与考核工作，及时处理员工提出的意见。 ➤Actively cooperate with HSE management to prevent accidents happens. 积极配合HSE管理工作，防止各类事故的发生。 ➤ Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation. 定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。 ➤Participate in the investigation for accidents, analyses the root causes of accidents from the quality management perspective, and related CAPA. 参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。 ➤Responsible for design annual department PASS plan and ensure implementation as planned. 负责制定年度部门PASS计划，并按进度组织实施。

无菌生产经验 英文良好 本科以上，不带人岗位