职位描述
工作职责
1. Ensure the GLP and GMP compliance in QC laboratory.
保证实验室的各方面符合GLP，GMP的要求
2. Instruct supervisors to prepare of Training plan, train, make employee working normatively and effectively.
指导主管制定对部门员工的培训计划，实施培训，使员工的工作规范有效
3. Ensure Testing standard current and effective, make employee perform analysis according to Testing Standard.
保证测试标准的现行性，有效性，保证员工按照测试标准进行分析
4. Take charge of OOS investigation.
对实验室分析结果超标负责进行调查
5. Improve the SOP system in QC lab, ensure employee working following SOPs.
完善实验室的SOP系统，保证员工按照SOP规定工作
6. Prepare the annual budget, objectives & training plans based on company’s objective.
根据公司目标，制定本部门年度预算，年度目标和培训计划
7. Check the protocol and report of validation, QC SOPs and sign them.
复核， 签发验证计划书，验证报告和本部门的标准操作规程
8.Review the QC cycle time, labor hours and material consumption quarterly to improve the QC operation cost-
effectively and improve the productivity.
回顾QC的月度分析周期和工时，提高劳动生产率；回顾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
合理分配资源，保证产品的分析与放行符合生产放行计划
10.Responsibility for environment protection, employees health and occupational safety in the department.
对本部门的环境，健康和安全负全面责任
11.Complete other assignments given by superior
完成领导其他交办任务
相关工作经验要求:
5 years or above work experience of quality controlling in pharmaceutical company
五年或以上制药企业质控管理经验
Familiar with procedure of QC department ,pharmacopoeia and instrument methods .
熟悉QC的工作流程,药典和仪器方法
Familiar with GMP and related law and regulations.
熟悉药品GMP及相关的法律法规
