QA岗位详细要求

-只为成功找方法，不为失败找借口，最成功的人，是最重视找方法的人。- = =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.国际质量管理专员岗位详细要求：l 两年以上药企QA工作经验 如果之前岗位有部分职责是具体的质量管理，则候选人员可以是来自QA/QC 或生产部 如果之前岗位有部分职责是具体的质量管理，候选人可以是来自制药行业的某分析测试机构、研发机构或其他机构l 丰富的GMP知识（国内及国外） 候选人应熟悉国际协调委员会、国际药品稽查公约组织、世界卫生组织、欧洲药品管理局、美国食品药品管理局等GMP指南 候选人应熟悉国际GMP和中国GMP指南的具体区别 候选人应熟悉质量管理体系，如：质量回顾概述、风险管理、验证/确认管理、偏差管理、变更控制等 候选人应熟悉实验室分析检测设备的确认和分析方法的验证 候选人应熟悉相关的良好规范，如：优良生产质量管理规范、优良文件管理规范、优良实验室管理规范等。 候选人应熟悉新建/扩建/改造项目相关的GMP知识 候选人应熟悉原料药和/或制剂产品的生产工艺过程 候选人应具有很强的质量观念，即确保患者的安全（而不是为了应付官方机构的检查） 候选人对快速发展的GMP应具有很强的学习能力l 良好的组织能力 候选人应能够合理安排自己的工作并确保按期完成工作目标 候选人应能够合理安排客户（外部客户：官方机构、合作方等；内部客户：如生产、工程、销售等）方面的工作，以确保按期完成工作目标 候选人能够确定自己和客户方（解释如上所述）工作的里程碑，已确保按期完成工作目标 候选人应能发现潜在障碍并尽早跟相关方进行沟通和协调l 良好的沟通能力并且思维活跃，良好的团队合作能力 候选人应具备跟任何相关方就所有话题沟通协调的能力 候选人应具备就棘手事宜坦诚且全面深入沟通的能力 候选人应具备就目标和里程碑以专业的方式进行沟通协调的能力 候选人应具备以友好但坚决且有说服力的方式进行沟通协调的能力 候选人应具备用多种方法解决问题的能力 候选人应能够接受并尊重别人的观点，并能够以事实为依据进行讨论 候选人应具备分享观点且基于事实做决定和合理讨论所有人员以及各部门改进的信息 候选人应能够基于现有系统和情形独立提出新的改进建议以及具有创新思维的能力 候选人应能够带动客户（定义如上所述）并能够积极主动的推进工作和