• 一个优秀QA需要具备的知识

乳酸菌素

学到老活到老

你不够孤独

前面的我就不发表言论了，因为我不是这个专业的，但是当我看到第五条关于质量部分的时候瞬间不淡定了，六西格玛和minitab你想搞到有点懂的阶段没个5、6年纯粹是扯淡，即使把手头工作都放下猛加班专心学，当年通用电器那帮家伙也学了足足三个月才达到黑带水平（不相信的你们去看看通用电气前任CEO的自传）。。。想法不错，一般人我估计是做不到了。
话说这种不切实际的CPOY帖子也能上首页，蒲公英堕落了。

无为

分级太简单
还有其他分级，比如 心中无山

追风者

学习一下

纵横驰骋

纵横驰骋 发表于 2013-7-15 18:40

这是扣了我2分？不知道不能只发表情的，不好意思

朝霞小虾米

qa的要求这么高啊

panjingwen

学无止尽啊

缘来就是你

懂了《易经》就可以在药厂初建呢哈给它看风水什么的了，以后就没必要要QA这行当的人员了。

hoogle

总结的很好啊，学习了！

Jason

对QA 的要求是很高，但是一般生产系统根本不注重QA的职责，最难做的是要与生产个部门协调完善质量保证系统，平时不注重质量，等GMP认证时才看重QA，等认证通过后又回到从前的惯性了！

tokyc

不管怎么样，能发帖还是不错

开羽

《Good Manufacturing Practices for Pharmaceuticals, 6th Edition（GMP，6th）》（P26）。
FIGURE 1 Knowledge and skill requirements for today’s quality professional
Business Knowledge/Understanding
—Policies/Standards/Regulations
—Manufactured Products
—Pharm/Bio Industry Knowledge (Rx, OTC)
– local
—Global
—General Business (Mfg., Logistics, TS, Eng.)
—HR, Finance, Marketing/Sales, IS
Leadership & Management Skills
—Facilitiation and Training
—Positive Regard and Motivation
—Performance Assessment/Feedback/Coaching
—Team Building
—Networking
Communication Skills
—Oral
—Written
—Presentation
—Influencing
—Negotiation and Conflict Management
—Language
Process Skills
—Time Management
—Quality Planning
—Proposal Preparation
—Project Management & Planning
—Process Management
—Change Management
—Problem Solving/Decision Making
—Management Tools
—Risk Analysis & Management
Quality Design & Prevention
—Basic Quality Tools
—Process Capability and Statistical QC
—Process/System Design
—Design of Experiments (DOE)
—Failure Mode Effect Analysis (FMEA)
—Value Engineering/Analysis & Re Engineering
—Benchmarking
Validation
—Facilities/Critical Plant Systems (IQ/OQ/PQ)
—Production Equipment (IQ/OQ/PQ)
—Manufacturing Process Validation
—Retrospective Process Validation (data review)
—Equipment Cleaning Validation
—Computer System Validation
Manufacturing
—Formulations & Manufacturing Procedures
—Statistical Process Controls
—Process Capability
—Equipment & Processing Parameters
—Environmental Monitoring
Chemistry/Microbiology
—Good Laboratory Practices
—Latest Instrumentation & Automation
—LIMS or Lab Management systems
—Methods Development
—Methods Validation
Audit/Assessment (Auditor) Skills
—Pharmaceutical/Biological Operations
—Packaging Materials Operations
—Bulk Pharmaceutical Chemical (BPC) Op.
—ISO 9000
—Process/Systems Approach
Suppliers/Contractors/Third Parties
—Quality Assurance Of Suppliers
—Quality Assurance Of Third Parties
—Partnership Management
Quality Systems
—Policies/Procedures
—Annual Product Review (APR)
—Complaints
—Failure Investigations/Materials Decisions
—Product Release
—Change Control
—Components, Materials/Warehousing/Dist.
—Calibration & Maintenance
—Management Notification
—Training
—Recall
—Technology Transfer
Customer Awareness/Understanding
—Complaint Handling
—Product Audits/Competitive Comparisons
—Customer Visits/Interviews
—Market/Customer Surveys
—Next Operation as Customer (NOAC)
—Six Sigma Approach
最后我还是想说，火星教授猿狩先生写的QA的十个层次更好一点。推荐大家观看，看完别忘了砸蛋。

meikezjd

现在我还是见山是山啊 还要努力啊

千年一等

新QA看了这个，一头两个大啊

anson112

楼主分析得很到位！

wanggui_929

回家看书，学习

詹姆斯易

看山不是山飘过

人生红绿灯

楼主说得好，QA学无止境。

快乐的小鱼

到达最后这个层次，你可以专门做培训啦