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Online Resumes with "CAPA "
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
Biologist - 13 Years of Experience - Near 20874
Summary Downstream process professional with ten years of experience spanning development, clinical manufacturing, and commercial manufacturing in biotechnology companies. * Experienced in biologics process development, process scale-up, process optimization, and manufacturing. * Authored, reviewed, implemented, and executed technical reports, science journal articles, process run summaries, investigation reports, CAPA, cha...
Tags for this Online Resume: Manufacturing, Compliance, Science, Support, Biotechnology, Inventory, Logistics, Management, Microsoft Office, Microsoft Visio
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Quality Manager
AREAS OF EXPERTISE Continuous Process Improvement ( Quality Assurance ( Problem Resolution ( Cost Reduction APQP ( AQP ( PPAP ( PCPA ( QSB ( DOE ( Run at Rate ( Top Focus ( Layered Process Audits TQM ( 8D ( CAPA ( Red-X ( Shainin ( Lean Manufacturing ( Training ( Cellular Manufacturing DFSS ( Prototype Launch ( Systems Automation ( Process Efficiency ( Cross-Functional Leadership SUMMARY ( Progressive growth in automotive, ...
Tags for this Online Resume: Engineering, Training, ISO, Plastics, Test, PPAP, Quality, Quality Assurance, Quality Control, Injection Molding
Not Listed - 13 Years of Experience - Near 10956
SUMMARY An accomplished, charismatic and energetic leader with over 20 years progressive experience in multiple regulated industries. Expertise in Regulatory Compliance, Supplier Quality, Quality Assurance, Quality Control, domestic US cGMP (QSR) and international Quality Management System (QMS) implementation and/or improvement. Experience with US and European Regulatory Agencies and an expert facilitator for FDA and other...
Tags for this Online Resume: New Jersey, Management, people management, Facilitator, Internal audit, ISO, FDA, LMS, MDR, Supplier Quality, Quality Assurance, QMS, Validation, Quality Agreement, CAPA, QSR, cGMP
Quality Manager - 6 Years of Experience - Near 46064
Tags for this Online Resume: Quality, Data Management, Engineering, Supplier Quality, Management, CAPA, Project Management, TS16949, Audits, 8D, KPI, Root Cause
Director
Dedicated and Strategic QA Professional with more than fifteen years of progressive experience in both large and small pharmaceutical companies both US based and international. Extensive experience in development through commercialization of solid oral dosage products. Comprehensive knowledge of cGXP and ICH guidelines. Leader of process and manufacturing compliance, document control programs, QA analytical sciences, vali...
Tags for this Online Resume: Internal and External Audits, Vendor Management, Quality Systems, CAPA, Customer Complaints, Chemistry Machine Control
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
Quality Manager - 20 Years of Experience - Near 19518
SUMMARY OF QUALIFICATIONS: * Dynamic, ethical business leader focused in on Executive Quality Management and Operations * A strong Quality Management background mixed with high levels of Program/Project Management assists in analyzing and building a competitive solution related to company Projects within a Lean/Agile type environment * Candid ability to provide project scope data related to budgetary time lines that effect ...
Tags for this Online Resume: Project Mgmt., Program Mgmt., Disaster Recovery, e-Commerce, Integrate, Microsoft .Net, Client facing, Performance Testing, Configuration Management, Risk, CAPA
Quality Engineer - 3 Years of Experience - Near 48334
Qualifications Profile Performance-focused, detail-oriented, and multifaceted engineer, offering hands-on experience in quality engineering complemented with strong ability to prepare project-specific documents and a comprehensive understanding of Manufacturing Process. Skilled at performing DMAIC, APQP, PPAP, DFMEA, PFMEA, Lean Manufacturing and conducting field inspection of works, field testing of materials, as well as i...
Tags for this Online Resume: Quality, Quality Assurance, 5S, APQP, Audit, Compliance, DFMEA, Engineering, English Language, Failure Analysis, Six Sigma, PPAP, FMEA, DMAIC, PDCA, RCA, CAPA, SPC, MSA
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Electrical Tester - 15 Years of Experience - Near 85022
ACCOMPLISHMENTS: multi-discipline responsibilities in Electronics Design, Mfg., and Test * Design analog power circuits for test fixtures saving the company capital test equipment purchases for characterization of NPI and DFT. * Build and test 4 state-of-the-art aerospace RF & Active 3D RADAR portable Com Sys (ATC) including transceivers, high power generator, and command shelters for remote installations. * Perform employe...
Tags for this Online Resume: Aerospace, Autocad, Autodesk AutoCAD, Automatic Test Equipment, Avionics, C Programming Language, Clean Room, EDM, Electronics, FORTRAN
