供应链质量体系专员

Job Responsibilities 岗位职责
1.Responsible for the normal operation, maintenance and improvement of SCM quality system, to ensure the quality management meet the regulations compliance.
负责监供应链部门日常质量管理体系的运营和维护，确保符合法规要求;
2.Responsible for the management, tracking of deviation, CAPA, CR, and the OOS related the materials, ensuring the timeliness of quality handling.
负责偏差，CAPA及变更，涉及物料的OOS的管理和跟踪推进，确保质量事件处理的及时效性;
3.Participate in and organize the implementations of GMP internal or external audits, and supporting for the warehouse on-site audit reception and subsequent audit response, and tracking of correct of findings after audit.
参与，组织实施GMP自检和外部审计,支持仓库现场的迎审接待及后续审计回复，以及审计结束后的缺陷项的整改跟踪;
4.Responsible for GMP making training plans and maintenance for the department personnel, and the development, coordination, tracking, and completion of training activities in the department, as well as the management of employee training files.
负责部门人员GMP培训计划的制定和维护，及部门培训工作的开展，协调，跟踪，完成培训活动，及员工培训档案管理。;
5.Responsible for drafting, reviewing, training, approval, issuing, archiving recovering of department GMP management documents.
负责部门内GMP管理文件的起草，审核，培训，生效，发放，存档和回收等;
6.Responsible for numbering, issuing, recovering and archiving of kinds of records.
负责各类记录的编号，发放，收回和归档;
7.Responsible for the verification, calibration and other auxiliary work related to warehouse equipment and facilities, including the drafting and approval of URS and SRA, etc., and cooperate with the ENG department to complete the calibration-related work.
负责仓库设备设施等涉及的验证，校准等相关辅助性工作,包括URS, SRA的起草及签批生效等，协同ENG部门完成校准相关工作;
8.Responsible for the quality management review and analysis within the department.
负责部门内部的质量管理回顾与分析;
9.Assist in providing relevant records or data required by clients for supply chain management.
协助提供客户针对供应链管理需要提供的相关记录文件或是数据;
10.Assist in completing other work within the department, equipment procurement requirements and other departmental expenses, purchase application and acceptance, etc.
协助完成部门内部的其他的工作，设备的采购需求及其他部门费用采购申请及验收等;
11.Assist in completing other temporary work arranged by department leaders.
协助完成部门领导安排的其他的临时性工作。
Job Requirements 岗位要求
1.Bachelor's degree or above in pharmacy or related majors.
药学或是相关专业本科及以上学历；
2.More than 3 years of experience in quality management or on-site supervision and management of pharmaceutical manufacturers, familiar with the basic business processes of warehouses.
有3年以上药品生产企业质量管理或是现场监督管理经验，熟悉仓库基本业务流程；
3.Familiar with local GxP guidelines, policies and regulations is a plus.
了解制药的相关要求、规章以及法规；
4.Familiar with supplier management and material management；Familiar with regulation requirement of warehouse equipment and facilities.
熟悉供应商,物料管理管理流程，熟悉仓库设备设施的基于 法规的要求；
5.Ability to communicate and collaborate across functional groups in completing necessary job requirements.
具有跨组织的沟通协作能力保证按时完成工作；
6.CET 4 or CET 6.
英语四六级证书。