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Online Resumes with "FDA quality systems"
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager
Quality Assurace Masnager
Director of Quality Verstal in ISO and FDA Quality Systems.
Ideal Companies: aerospace, Medical
Tags for this Online Resume: NDT, Inspection, R&D, Welding
manager
Over twenty (20) years of experience in the manufacture and packaging of pharmaceutical solid and semi-solid dosage forms. Results-oriented achiever with managerial experience in start ups at pharmaceutical facilities, validation processes and product launches. Goal- oriented individual with strong leadership capabilities. Organized highly motivated, and detail- directed problem solver. Depth knowledge in current and ne...
Tags for this Online Resume: DOE, trackwise, Product Transfer, microsoft , c'GMP, Lean Manufacturing
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
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
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Quality Manager - 12 Years of Experience
Professional Summary Self-motivated, energetic and effective leader with 13+ years of experience (8Years of leadership/managerial role) in quality assurance in pharmaceuticals, biologics, Complex injectables, Oncology and combination products. Proven to successfully design and implement quality systems and drive positive change in fast paced environments. Decisive leader who will apply initiative and innovation to establish...
Tags for this Online Resume: Management, Oncology, Manufacturing, Quality Assurance, Test, Quality, Quality Management, Documentation, Audit, Filing
Chemist - 8 Years of Experience - Near 08855
SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical
Life Scientist
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, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices
