職責(zé)內(nèi)容Responsibilities
?負(fù)責(zé)集團(tuán)GSP質(zhì)量管理體系的策劃、實(shí)施與持續(xù)改進(jìn),確保符合《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》要求
Responsible for the planning, implementation and continuous improvement of GSP quality management system(QMS)in headquarter of Anrate to ensure compliance with GSP
?建立集團(tuán)GSP相關(guān)質(zhì)量體系管理文件并持續(xù)完善,并監(jiān)督相關(guān)流程的執(zhí)行
Establish the relevant GSP QMS documents for headquarter of Anrate and continuously improve, and supervise the execution of related processes
?制定集團(tuán)GSP相關(guān)培訓(xùn)計(jì)劃,主導(dǎo)或協(xié)助開(kāi)展GSP相關(guān)法規(guī)、流程及專業(yè)培訓(xùn),并監(jiān)督確認(rèn)培訓(xùn)的效果
Develop a GSP related training plan for headquarter of Anrate, lead or assist in conducting training for GSP related regulations, procedures, and profession, supervise and confirm the effectiveness of the training
?指導(dǎo)集團(tuán)下屬分、子經(jīng)營(yíng)公司依照法規(guī)、指導(dǎo)原則相關(guān)要求建立合規(guī)的質(zhì)量管理體系,并監(jiān)督執(zhí)行
Guide the subsidiaries and affiliates of Anrate to establish a compliant quality management system in accordance with the relevant requirements of laws and regulations, and supervise the implementation
?主導(dǎo)或協(xié)助集團(tuán)及其分、子公司的內(nèi)部和外部審計(jì),包括但不限于GSP認(rèn)證、突擊檢查和年度自查,以確保成功。
Lead or assist in internal and external audits, including but not limited to GSP certification, unannounced inspections and annual self-inspections, for headquarter of Anrate and its subsidiaries and affiliates to ensure the success.
?協(xié)助對(duì)GSP相關(guān)質(zhì)量文件、記錄進(jìn)行管理與存檔。
Assist in the management and archiving of GSP related quality documents and records.
?完成領(lǐng)導(dǎo)安排的其他工作。
Complete other tasks assigned by the leader.
任職要求Qualifications
?藥學(xué)、化學(xué)、醫(yī)學(xué)等相關(guān)專業(yè),本科及以上學(xué)歷
Bachelor degree or above in pharmacy, chemistry, medicine and other related majors
?醫(yī)藥行業(yè)7年以上工作經(jīng)歷,其中至少有3年以上GSP質(zhì)量管理工作經(jīng)驗(yàn)
More than 7 years of work experience in the pharmaceutical industry, including at least 3 years of GSP quality management experience
?熟悉國(guó)內(nèi)外GSP相關(guān)法規(guī)及原則,具備質(zhì)量管理的專業(yè)知識(shí)和技能
Familiar with GSP regulations and principles at home and abroad, with professional knowledge and skills in quality management
?良好的邏輯思維能力、計(jì)劃與執(zhí)行能力、溝通能力,具備較強(qiáng)的學(xué)習(xí)能力
Good logical thinking ability, planning and execution ability, communication ability, and have strong learning ability
?有良好的英語(yǔ)聽(tīng)說(shuō)讀寫(xiě)能力
Good oral and written English skills
?能夠接受少量出差
Able to have business trips occasionally.