QA崗位詳細(xì)要求

-只為成功找方法，不為失敗找借口，最成功的人，是最重視找方法的人。- = =International Quality Implementation OfficerDetailed requirements:l At least 2 years of experience in pharmaceutical quality assurance. The candidate can be coming from a QA/QC department or from a production department if specific quality related responsibility has been part of the former job. The candidate can be coming from an analytical, research, or other institute for pharmaceutical industry if specific quality related responsibility has been part of the former job.l Good knowledge of pharmaceutical GMP (Chinese and international). The candidate should have knowledge of GMP related guide lines such as ICH, PIC/S, WHO, EMA, FDA, etc. The candidate should know the specific differences between international and Chinese guide lines. The candidate should be familiar with quality systems such as quality overview, risk management, validation management, deviation management, change management, etc. The candidate knows the processes of laboratory equipment qualification and validation of analytical methods. The candidate should be familiar with good practices such as GMP, GDP, GLP, etc. The candidate has GMP knowledge in construction projects. The candidate has knowledge of API and/or FPP processes The candidate understands that quality is in order to ensure patients safety (and not because of authorities). The candidate is able to learn in the field of quick changing GMP environment.l Organizational skills. The candidate is able to organize the own work in order to meet time lines and goals. The candidate is able to organize the work of customers in order to meet time lines and goals. The candidate can define milestones for the own work and for the work of the suppliers in order to meet agreed goals and time lines. The candidate has the ability to realize obstacles and to communicate them as early as possiblel Communicative and open minded as well as good at teamwork The candidate is able to communicate all kinds of topics who ever the counterpart is. The candidate can communicate truly and comprehensively even it is about difficult issues. The candidate has a professional way to communicate goals and miles stones. The candidate is able to communicate in a friendly but decisive and convincing way. The candidate is able and open to see alternative ways to solve problems or issues. The candidate is able to accept and respect other persons opinions and can discuss based on facts. The candidate is ready to share ideas and make decisions based on facts and reasonable discussions including all persons and departments inputs. The candidate is able to provide new ideas for improvement and can develop innovative thinking independent on existing systems and definitions. The candidate is able to motivate customers and takes the initiative to push work progress and persons. Honesty has to be a basic feature of the candidates characterl Ability of strict timeliness of work completion is a must. The candidate is able to adhere strictly to timelines. The candidate is able to adjust the work in case of obstacles in order to meet time lines The candidate is able to influence the customers work in order to meet time lines. The candidate communicates obstacles as early as possible if time lines cannot be met.l Ability of in-depth analysis of systems and procedures is required. The candidate has the ability to dive deep into systems or problems in order to understand completely the very basic facts. The candidate is able to think in an abstractive and analytical way. The candidate does not stop an investigation or analysis until the basis is found. The candidate is able to depict complicated issue in a simplified, understandable but still correct way. The candidate is satisfied by persistent questioning and researching for real causes and basic facts.l Ability to work under pressure is required. The candidate can provide the same quality of work and behavior even the pressure is high. The candidate can withstand strong resistance of customers and can ensure quality standards. The candidate is ready to work over time during high pressure periods in order to meet goals and time lines.l Ability to work according to standards, SOPs, and defined/common procedures. The candidate is able to adhere to defined internal processes and guide lines (even they maybe are not suitable or reasonable). The candidate is able to record true information. The candidate can see differences between defined processes and behavior or work of him/herself or others and make proposal for adjustments if necessary. The candidate understands how to handle non-suitable or non-reasonable procedures (e.g. by change management).l Spoken and written English and Chinese is a must. Written English has to be on a high level. Oral English can be on a lower level, but has to be improved later.國(guó)際質(zhì)量管理專員崗位詳細(xì)要求：l 兩年以上藥企QA工作經(jīng)驗(yàn) 如果之前崗位有部分職責(zé)是具體的質(zhì)量管理，則候選人員可以是來自QA/QC 或生產(chǎn)部 如果之前崗位有部分職責(zé)是具體的質(zhì)量管理，候選人可以是來自制藥行業(yè)的某分析測(cè)試機(jī)構(gòu)、研發(fā)機(jī)構(gòu)或其他機(jī)構(gòu)l 豐富的GMP知識(shí)（國(guó)內(nèi)及國(guó)外） 候選人應(yīng)熟悉國(guó)際協(xié)調(diào)委員會(huì)、國(guó)際藥品稽查公約組織、世界衛(wèi)生組織、歐洲藥品管理局、美國(guó)食品藥品管理局等GMP指南 候選人應(yīng)熟悉國(guó)際GMP和中國(guó)GMP指南的具體區(qū)別 候選人應(yīng)熟悉質(zhì)量管理體系，如：質(zhì)量回顧概述、風(fēng)險(xiǎn)管理、驗(yàn)證/確認(rèn)管理、偏差管理、變更控制等 候選人應(yīng)熟悉實(shí)驗(yàn)室分析檢測(cè)設(shè)備的確認(rèn)和分析方法的驗(yàn)證 候選人應(yīng)熟悉相關(guān)的良好規(guī)范，如：優(yōu)良生產(chǎn)質(zhì)量管理規(guī)范、優(yōu)良文件管理規(guī)范、優(yōu)良實(shí)驗(yàn)室管理規(guī)范等。 候選人應(yīng)熟悉新建/擴(kuò)建/改造項(xiàng)目相關(guān)的GMP知識(shí) 候選人應(yīng)熟悉原料藥和/或制劑產(chǎn)品的生產(chǎn)工藝過程 候選人應(yīng)具有很強(qiáng)的質(zhì)量觀念，即確?；颊叩陌踩ǘ皇菫榱藨?yīng)付官方機(jī)構(gòu)的檢查） 候選人對(duì)快速發(fā)展的GMP應(yīng)具有很強(qiáng)的學(xué)習(xí)能力l 良好的組織能力 候選人應(yīng)能夠合理安排自己的工作并確保按期完成工作目標(biāo) 候選人應(yīng)能夠合理安排客戶（外部客戶：官方機(jī)構(gòu)、合作方等；內(nèi)部客戶：如生產(chǎn)、工程、銷售等）方面的工作，以確保按期完成工作目標(biāo) 候選人能夠確定自己和客戶方（解釋如上所述）工作的里程碑，已確保按期完成工作目標(biāo) 候選人應(yīng)能發(fā)現(xiàn)潛在障礙并盡早跟相關(guān)方進(jìn)行溝通和協(xié)調(diào)l 良好的溝通能力并且思維活躍，良好的團(tuán)隊(duì)合作能力 候選人應(yīng)具備跟任何相關(guān)方就所有話題溝通協(xié)調(diào)的能力 候選人應(yīng)具備就棘手事宜坦誠(chéng)且全面深入溝通的能力 候選人應(yīng)具備就目標(biāo)和里程碑以專業(yè)的方式進(jìn)行溝通協(xié)調(diào)的能力 候選人應(yīng)具備以友好但堅(jiān)決且有說服力的方式進(jìn)行溝通協(xié)調(diào)的能力 候選人應(yīng)具備用多種方法解決問題的能力 候選人應(yīng)能夠接受并尊重別人的觀點(diǎn)，并能夠以事實(shí)為依據(jù)進(jìn)行討論 候選人應(yīng)具備分享觀點(diǎn)且基于事實(shí)做決定和合理討論所有人員以及各部門改進(jìn)的信息 候選人應(yīng)能夠基于現(xiàn)有系統(tǒng)和情形獨(dú)立提出新的改進(jìn)建議以及具有創(chuàng)新思維的能力 候選人應(yīng)能夠帶動(dòng)客戶（定義如上所述）并能夠積極主動(dòng)的推進(jìn)工作和