職位描述
工作職責
1. Ensure the GLP and GMP compliance in QC laboratory.
保證實驗室的各方面符合GLP，GMP的要求
2. Instruct supervisors to prepare of Training plan, train, make employee working normatively and effectively.
指導主管制定對部門員工的培訓計劃，實施培訓，使員工的工作規范有效
3. Ensure Testing standard current and effective, make employee perform analysis according to Testing Standard.
保證測試標準的現行性，有效性，保證員工按照測試標準進行分析
4. Take charge of OOS investigation.
對實驗室分析結果超標負責進行調查
5. Improve the SOP system in QC lab, ensure employee working following SOPs.
完善實驗室的SOP系統，保證員工按照SOP規定工作
6. Prepare the annual budget, objectives & training plans based on company’s objective.
根據公司目標，制定本部門年度預算，年度目標和培訓計劃
7. Check the protocol and report of validation, QC SOPs and sign them.
復核， 簽發驗證計劃書，驗證報告和本部門的標準操作規程
8.Review the QC cycle time, labor hours and material consumption quarterly to improve the QC operation cost-
effectively and improve the productivity.
回顧QC的月度分析周期和工時，提高勞動生產率；回顧QC的物品消耗，降低分析成本
9. Allocate resource to assure analysis and release of products following manufacturing and release schedule
合理分配資源，保證產品的分析與放行符合生產放行計劃
10.Responsibility for environment protection, employees health and occupational safety in the department.
對本部門的環境，健康和安全負全面責任
11.Complete other assignments given by superior
完成領導其他交辦任務
相關工作經驗要求:
5 years or above work experience of quality controlling in pharmaceutical company
五年或以上制藥企業質控管理經驗
Familiar with procedure of QC department ,pharmacopoeia and instrument methods .
熟悉QC的工作流程,藥典和儀器方法
Familiar with GMP and related law and regulations.
熟悉藥品GMP及相關的法律法規
