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Online Resumes with "quality system regulations"
Manager on Pharmaceutical industry- 19 years experience- Mfg Solid Dosage/ aseptic
Successful professional with over nineteen (19) years of experience in the pharmaceutical industry Solid Dosage and Aseptic Process Technology. Results-oriented achiever with strong background in manufacturing/packaging/warehouse operations, chemical laboratory ( Biotechnology Product Analisis and Mfg Process Knowledge ) and project management. Experience with Manufacturing Execution Systems (MES), FDA Quality System Regula...
Tags for this Online Resume: Atlanta, Manager, Manufacturing, Aseptic, Solid Dosage, Project Management
Creative Project Engineer / Manager with Black Belt
Add values to an organization requiring my background -More than 15 years of professional experience in design & development of new processes and continuous improvement of existing processes to provide cost effective solutions to Engineering, products, procedures and system challenges
Tags for this Online Resume: • Black Belt Six Sigma, • Project Management: Capital and Continuous Improvement projects , • New Processes / Product Mfg systems design and development , • Proven application of Cost reduction & Lean techniques, • ISO 9000 Lead Auditor, • Medical Quality System regulations
Office Manager - 7 Years of Experience - Near 32043
Energetic and Reliable Team Player with great work ethic. Looking to be employed with a company that will offer stability and growth potential.
Tags for this Online Resume: Jacksonville, FL, Manager, Healthcare, office, Leader, Orange Park, FL, Green Cove Springs, FL, Team Player
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Department Manager - 20 Years of Experience - Near 02356
QUALIFICATIONS SUMMARY Extensive experience in Research and Development, Manufacturing Engineering, Test Engineering, Technical Operations and Quality developing, introducing new products and supporting Electro-Mechanical devices. Experienced in working with all facets of the business, internal and external, to increase throughput, quality and product reliability while minimizing cost. Experiences include new product intro...
Tags for this Online Resume: Engineering , Manufacturing, Test, NPI, Concurrent, FDA, Medical, Quality
Quality Engineer
Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control sy...
Tags for this Online Resume: Compliance, Quality Assurance, Support, Technical Support, Test, Corrective Actions, Medical, Medical Devices, ISO, Audit
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Quality Manager - 15 Years of Experience - Near 46143
SUMMARY A results-oriented achiever with a rich background of diverse responsibilities in the medical diagnostic and pharmaceutical industries. Exceptional relationship building skills. Track record of a self-starter, constantly looking to identify and implement cost reductions, product and process improvements. A strong communicative, organized, detail oriented, and project planning/executing leader. Skilled in managing no...
Tags for this Online Resume: Management, Document Management, Quality Assurance, Test, ISO, Project Management, Project Manager, SAP, Documentation, Orthopedics
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Quality Manager - 16 Years of Experience - Near 30038
SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...
Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans
Customer Service Manager - 7 Years of Experience - Near 92887
Summary: Utilize my skills, knowledge and experience for your company whereby my team leadership and business expertise can enhance profitability as well as improve the outcome of your growth-orientated business. Accomplishments: * Followed Quality System Regulations & Requirements for Regulatory Purposes (FDA regulated, ISO & OSHA standards, SOP's). * Created Standard Operating Procedures for warehousing, logistics and inv...
Tags for this Online Resume: Leadership, Accounts Receivable, customer service, customer service representative, Accounts payable, Medical industry, Warehouse Manager, SOP's and Quality Documentation, Account management, Staff accountant, Inventory conrol, Purchasing, Sales operations representative, Order entry, Invoicing