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Job Responsibilities 崗位職責
1.Responsible for the normal operation, maintenance and improvement of SCM quality system, to ensure the quality management meet the regulations compliance.
負責監(jiān)供應鏈部門日常質量管理體系的運營和維護，確保符合法規(guī)要求;
2.Responsible for the management, tracking of deviation, CAPA, CR, and the OOS related the materials, ensuring the timeliness of quality handling.
負責偏差，CAPA及變更，涉及物料的OOS的管理和跟蹤推進，確保質量事件處理的及時效性;
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.
參與，組織實施GMP自檢和外部審計,支持倉庫現(xiàn)場的迎審接待及后續(xù)審計回復，以及審計結束后的缺陷項的整改跟蹤;
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.
負責部門人員GMP培訓計劃的制定和維護，及部門培訓工作的開展，協(xié)調，跟蹤，完成培訓活動，及員工培訓檔案管理。;
5.Responsible for drafting, reviewing, training, approval, issuing, archiving recovering of department GMP management documents.
負責部門內GMP管理文件的起草，審核，培訓，生效，發(fā)放，存檔和回收等;
6.Responsible for numbering, issuing, recovering and archiving of kinds of records.
負責各類記錄的編號，發(fā)放，收回和歸檔;
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.
負責倉庫設備設施等涉及的驗證，校準等相關輔助性工作,包括URS, SRA的起草及簽批生效等，協(xié)同ENG部門完成校準相關工作;
8.Responsible for the quality management review and analysis within the department.
負責部門內部的質量管理回顧與分析;
9.Assist in providing relevant records or data required by clients for supply chain management.
協(xié)助提供客戶針對供應鏈管理需要提供的相關記錄文件或是數(shù)據(jù);
10.Assist in completing other work within the department, equipment procurement requirements and other departmental expenses, purchase application and acceptance, etc.
協(xié)助完成部門內部的其他的工作，設備的采購需求及其他部門費用采購申請及驗收等;
11.Assist in completing other temporary work arranged by department leaders.
協(xié)助完成部門領導安排的其他的臨時性工作。
Job Requirements 崗位要求
1.Bachelor's degree or above in pharmacy or related majors.
藥學或是相關專業(yè)本科及以上學歷；
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年以上藥品生產企業(yè)質量管理或是現(xiàn)場監(jiān)督管理經(jīng)驗，熟悉倉庫基本業(yè)務流程；
3.Familiar with local GxP guidelines, policies and regulations is a plus.
了解制藥的相關要求、規(guī)章以及法規(guī)；
4.Familiar with supplier management and material management；Familiar with regulation requirement of warehouse equipment and facilities.
熟悉供應商,物料管理管理流程，熟悉倉庫設備設施的基于 法規(guī)的要求；
5.Ability to communicate and collaborate across functional groups in completing necessary job requirements.
具有跨組織的溝通協(xié)作能力保證按時完成工作；
6.CET 4 or CET 6.
英語四六級證書。