職位描述
工作職責(zé)
1. Ensure the GLP and GMP compliance in QC laboratory.
保證實(shí)驗(yàn)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(dǎo)主管制定對(duì)部門員工的培訓(xùn)計(jì)劃，實(shí)施培訓(xùn)，使員工的工作規(guī)范有效
3. Ensure Testing standard current and effective, make employee perform analysis according to Testing Standard.
保證測(cè)試標(biāo)準(zhǔn)的現(xiàn)行性，有效性，保證員工按照測(cè)試標(biāo)準(zhǔn)進(jìn)行分析
4. Take charge of OOS investigation.
對(duì)實(shí)驗(yàn)室分析結(jié)果超標(biāo)負(fù)責(zé)進(jìn)行調(diào)查
5. Improve the SOP system in QC lab, ensure employee working following SOPs.
完善實(shí)驗(yàn)室的SOP系統(tǒng)，保證員工按照SOP規(guī)定工作
6. Prepare the annual budget, objectives & training plans based on company’s objective.
根據(jù)公司目標(biāo)，制定本部門年度預(yù)算，年度目標(biāo)和培訓(xùn)計(jì)劃
7. Check the protocol and report of validation, QC SOPs and sign them.
復(fù)核， 簽發(fā)驗(yàn)證計(jì)劃書(shū)，驗(yàn)證報(bào)告和本部門的標(biāo)準(zhǔn)操作規(guī)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(shí)，提高勞動(dòng)生產(chǎn)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(chǎn)品的分析與放行符合生產(chǎn)放行計(jì)劃
10.Responsibility for environment protection, employees health and occupational safety in the department.
對(duì)本部門的環(huán)境，健康和安全負(fù)全面責(zé)任
11.Complete other assignments given by superior
完成領(lǐng)導(dǎo)其他交辦任務(wù)
相關(guān)工作經(jīng)驗(yàn)要求:
5 years or above work experience of quality controlling in pharmaceutical company
五年或以上制藥企業(yè)質(zhì)控管理經(jīng)驗(yàn)
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(guān)的法律法規(guī)
