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注册时间2013-2-25
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性别保密
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发表于 2013-5-31 10:37:26
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FIGURE 1 Knowledge and skill requirements for today’s quality professionalBusiness 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, ISLeadership & Management Skills—Facilitiation and Training—Positive Regard and Motivation—Performance Assessment/Feedback/Coaching—Team Building—NetworkingCommunication Skills—Oral—Written—Presentation—Influencing—Negotiation and Conflict Management—LanguageProcess Skills—Time Management—Quality Planning—Proposal Preparation—Project Management & Planning—Process Management—Change Management—Problem Solving/Decision Making—Management Tools—Risk Analysis & ManagementQuality 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—BenchmarkingValidation—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 ValidationManufacturing—Formulations & Manufacturing Procedures—Statistical Process Controls—Process Capability—Equipment & Processing Parameters—Environmental MonitoringChemistry/Microbiology—Good Laboratory Practices—Latest Instrumentation & Automation—LIMS or Lab Management systems—Methods Development—Methods ValidationAudit/Assessment (Auditor) Skills—Pharmaceutical/Biological Operations—Packaging Materials Operations—Bulk Pharmaceutical Chemical (BPC) Op.—ISO 9000—Process/Systems ApproachSuppliers/Contractors/Third Parties—Quality Assurance Of Suppliers—Quality Assurance Of Third Parties—Partnership ManagementQuality 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 TransferCustomer Awareness/Understanding—Complaint Handling—Product Audits/Competitive Comparisons—Customer Visits/Interviews—Market/Customer Surveys—Next Operation as Customer (NOAC)—Six Sigma Approach |
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