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Online Resumes with "FDA"
Accountant - 21 Years of Experience
AND ACCOMPLISHMENTS
Tags for this Online Resume: Accounts Receivable, Accounting, Accounting Software, Financial Accounting, SAP, Software, Accounting Principles, Accounts Payable, Bad Debt, Balance
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
Facilities Manager
Summary Experienced Facilities and Maintenance Manager focused on increasing organizational efficiency and productivity by guaranteeing that facilities and equipment are kept in optimal running condition. ACCOMPLISHMENTS Managed and maintained 4 facilities in the Athens area Oversaw construction completion and ontime opening of 3 new facilities Oversaw ontime closure and decommissioning of 2 old facilities Negotiated PM con...
Tags for this Online Resume: Accounts Receivable, Blue Prints, Blueprints, HVAC, Distribution, Documentation, Instrumentation, Manufacturing, Schematics, Training
President - 0 Years of Experience - Near 21804
SUMMARY OF QUALIFICATIONS Extremely dedicated and detail-oriented professional with an extensive record of improving operations in the trucking industry to achieve unprecedented cost-efficiency utilizing proven expertise in the following areas: Areas of Expertise * Cargo Loss Prevention * Cargo Theft Prevention * Crisis Management * Risk Management * Team Building & Training * DOT Compliance * OSHA Compliance * Safety Compl...
Tags for this Online Resume: Compensation, Distribution, Occupational Safety and Health Act, OSHA, Compliance, Safety Equipment, Training, Security, Microsoft Internet Explorer, Pharmaceutical Industry, management, manager, Consultant, Transporation Managment, Violation, Logistics Managment, Quality Assurance, Transportation Consultant, Violation Consultant, Quality Assurance Consultant, Logistics Consultant
Quality Manager
Profile: I am a Quality, Food Safety, Health & Safety as well as Environmental Management Systems practitioner and Auditor. I have a background in General and Food Biochemistry and a good working knowledge of Food Microbiology and Sustainability Standards. I am an FSPCA Preventive Controls Qualified Individual for Human Food according to the Food Safety Modernisation Act of the FDA. I have several years' experience comprisi...
Tags for this Online Resume: Training, Quality Assurance, Test, Audit, Documentation, Packaging, Regulatory Affairs, Retail, Statutory, Supply Chain
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Medical Scientist - 20 Years of Experience - Near 33027
Summary Accomplished, dynamic self-driven Quality and Operations Executive with many years of experience in engineering, manufacturing and quality management. Agile concept to completion, goal-oriented team leader committed to exceed expectations with demonstrated ability to prioritize, analyze, plan, and manage multiple personnel, departments and facilities. Personable, articulate and persuasive skilled leader and relation...
Tags for this Online Resume: Quality, Quality Assurance, Compliance, Test, Agile, Audit, Black belt, Engineering, Green Belt, Integrate
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control
Production Supervisor - 0 Years of Experience
HIGHLIGHTS OF QUALIFICATIONS 1. Many years of pharmaceutical leadership experience in a Biotech and parenteral drug-manufacturing environment. 2. Diversified experience in sterile manufacturing including bulk manufacturing, aseptic filling, component sterilization, freeze drying, environmental monitoring, inspection and packaging. 3. Knowledge of governmental cGMP, OSHA, DEA regulations and procedures, experience with FDA, ...
Tags for this Online Resume: Packaging, Inventory, Manufacturing, High Performance Liquid Chromatography (HPLC), Leadership, Monitoring, pH Meter, Spectrophotometer, Labor Relations, Occupational Safety and Health Act
Machine Operator
Tags for this Online Resume: Forklift, Forklift Operator, Willing to relocate
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
Chemist
PRIME RESPONSIBILITIES Reporting to Sr VP / CEO * Synthetic route scouting and feasibility study of new projects and proposals * Monitoring from development to delivery and reviews with respect to quality/time lines * Mentoring of teams on various activities such as PD optimization validation kilo lab pilot plant and tech transfer. Familiar with activities of API/inters/custom synthesis/CRO/CMO. * Budget preparation and pre...
Tags for this Online Resume: Pharmaceutical Industry, Budget Preparation, Budgeting, Chemistry, English Language, High Performance Liquid Chromatography (HPLC), Hindi Language, ISO, Prime, Process Improvements
