職位描述
協(xié)助QC 經(jīng)理建立化學(xué)實(shí)驗(yàn)室并維護(hù)實(shí)驗(yàn)室的日常運(yùn)行
Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab
起草，復(fù)核或更新相關(guān)的SOP，檢驗(yàn)方法和質(zhì)量標(biāo)準(zhǔn)
Prepare, review and updated related SOPs, test method and specifications
起草儀器的確認(rèn)方案，實(shí)施儀器的確認(rèn)試驗(yàn)并完成確認(rèn)報(bào)告，例如化學(xué)實(shí)驗(yàn)室儀器的安裝/運(yùn)行/性能確認(rèn)和再確認(rèn)
Prepare the qualification protocol, conduct the qualification activities for equipments and complete the qualification report, such as IQ/OQ/PQ or re-qualification for chem. Lab equipment.
參與技術(shù)轉(zhuǎn)移工作，實(shí)施分析方法轉(zhuǎn)移并完成分析方法轉(zhuǎn)移報(bào)告
Participate the technical transferring ，conduct the analytical method transferring work and complete the analytical method transferring report
起草分析方法驗(yàn)證/確認(rèn)方案，實(shí)施相關(guān)測(cè)試，完成驗(yàn)證/確認(rèn)報(bào)告，例如工藝驗(yàn)證，清潔驗(yàn)證，藥典方法確認(rèn)等
Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.
作為實(shí)驗(yàn)室計(jì)算機(jī)系統(tǒng)的本地管理員，清潔，維護(hù)試驗(yàn)儀器，聯(lián)系供應(yīng)商或合適的承包商完成儀器的確認(rèn)或校驗(yàn)，以確保儀器設(shè)備處于良好狀態(tài)
As local administrator of laboratory computerized system, Clean， maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status.
作為試劑管理員和對(duì)照品管理員協(xié)助化學(xué)實(shí)驗(yàn)室耗材管理，包括試劑，對(duì)照品，玻璃儀器，個(gè)人防護(hù)用品等
Assist in As administrator of reagent and reference standard, management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
復(fù)核檢驗(yàn)記錄，必要時(shí)協(xié)助OOS 調(diào)查
Perform analytical record double checking and assist in OOS investigations when necessary.
起草新員工的培訓(xùn)方案和確認(rèn)計(jì)劃并實(shí)施培訓(xùn)
Prepare the new staff training plan and qualification plan for new staff and conduct the training.
協(xié)助SHE 管理，確保試驗(yàn)室各項(xiàng)活動(dòng)符合公司SHE 的政策
Assist in SHE management to keep the lab to be in conformity with company SHE policy.
完成其他指定工作
Complete other assigned tasks
GMP 符合性
GMP compliance
嚴(yán)格執(zhí)行化學(xué)室的相關(guān)標(biāo)準(zhǔn)作業(yè)程序和規(guī)章制度
Follow related SOPs and regulations strictly in chemical lab.
及時(shí)按照SOP 的要求填寫相關(guān)文件記錄如批化驗(yàn)記錄、儀器使用和維護(hù)記錄等并保證內(nèi)容的準(zhǔn)確性
Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.
積極參加對(duì)自檢中所發(fā)現(xiàn)缺陷的整改
Take part in actively in correction to the observations found in self-inspection.
勝任能力COMPETENCIES
基本的分析化學(xué)知識(shí)；設(shè)定高目標(biāo)并通過持續(xù)改進(jìn)專業(yè)技能扮演國際化的角色；接受持續(xù)的培訓(xùn)去開拓新的分析領(lǐng)域
Have basic analytical chemistry knowledge and set high goal to improve professional skills to meet the requirement as ainternational role; receive continuous training to explore new analytical areas.
客戶第一
Customer focus
任何行動(dòng)都基于滿足內(nèi)外客戶的基本需求；發(fā)展并維持高效的客戶關(guān)系
Make both internal and external customers and their needs a primary focus of one’s actions; develop and sustain productive customer relationships.
團(tuán)隊(duì)精神
Team work
展現(xiàn)出強(qiáng)烈的意愿同來自部門內(nèi)部同事或外部同事為了共同的目標(biāo)而緊密工作的精神
Show strong willingness to work closely with peers within own unit or colleagues from other unitstoward a common goal.
結(jié)果為導(dǎo)向
Result oriented
為組織的成功和個(gè)人的貢獻(xiàn)建立挑戰(zhàn)性的目標(biāo)；努力實(shí)現(xiàn)或超越目標(biāo)
Establish stretched goals for organization successand personal accomplishments; strive to meet or exceed those goals.
學(xué)習(xí)和適應(yīng)能力
Learning /adaptability
