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Online Resumes with "FDA ICH"
Quality Assurance Manager, Auditor
Professional Scientist with extensive experience in quality control, quality assurance, auditing and regulatory compliance. Expertise in deviation, investigation, CAPA and method/specification development. In-depth knowledge of FDA and ICH regulations. Proven track record of hiring, coaching, motivating, empowering and managing people. An excellent communication, leadership and conflict management skills with ability to org...
Tags for this Online Resume: quality assurance, deviation, investigation, CAPA, LIMS, cGMP
Clinical Research 14 years experience
My objective is to use my extensive knowledge of clinical research, FDA, ICH, and GCP guidelines to obtain a career in the Pharmaceutical/Biotech industry.
Tags for this Online Resume: Clinical Reserach, IRB, Human Subject Protection, Audit, Monitor
Clinical Research Coordinator New Orleans, LA
Monitor assigned clinical trials, interact with all different department such as (monitoring resources, project manager, quality assurance and data management). Conduct site visits (initiation, monitoring and close out). Ensure the adherence to FDA, ICH & GCP regulations. Instruct the site staff in their roles and responsibilities in conducting clinical trials. Ensure the completion and collection of regulatory document...
Tags for this Online Resume: Clinical Research Coordinator, Data Manager, Medical Assistant
Quality Assurance Engineer
I am a Senior Quality Assurance Engineer with 20 years experience in the consumer good and food technology industries. I have expertise in QA, FDA and ICH/ISO compliance, R&D and manufacturing supply chain experience. I am a six sigma black belt equivalent(internal company training)
Clinical Research - 20 Years of Experience - Near 33406
• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...
Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
Senior pharmaceutical scientist with professional experience in drug safety, toxicology, biomarkers and clinical trials
Senior biomedical scientist with 14 years of pharmaceutical industry experience, in both the preclinical and clinical setting, with a focus on discovery and application of biomarkers of safety and efficacy. Served as line function expert on cross-functional project teams as well as extensive experience in leading specialty sub-teams. Excellent analytical, verbal and written communication skills, with extensive experience in...
Tags for this Online Resume: drug safety, biomarkers, clinical research, clinical trials, toxicology, data analysis, scientific writing
Chemist - 15 Years of Experience - Near 07747
SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...
Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager
Clinical Research - 20 Years of Experience - Near 60202
QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience ...
Tags for this Online Resume: Project Leader, Executive Medical Director/VP, Protocol, Cancer, COPD, Critical Care - Respiratory, OTC, Clinical Programs, Research and Development, CardioVascular, Pain & Inflammation
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Clinical Regional Monitoring - 10 Years of Experience - Near 20912
20/20, Addis Ababa University (CRO), Addis Ababa, Ethiopia, March 2005 to July 2006 Senior Clinical Research Associate - Opthalmology Studies, National Blindness, Low-Vision & Trachoma * Oversaw $3.5M study across 14 regional states to explore blindness, low-vision, and trachoma demonstrated sharp organizational skills in managing team of clinical data managers verifying data, and performing systematic networking of databas...
Tags for this Online Resume: Clinical Research, Research, Protocol, Collection, Critical Care - Neurology, Management, Neurology, Oncology, Quality, Quality Assurance
Clinical Research - 2 Years of Experience - Near 11418
SUMMARY: * 2 years of experience in the field of clinical data management, producing data review and management objects in various clinical studies and phases in daily bases. * Coding knowledge in MedDRA and WHO Drug systems, Sound knowledge in US FDA and ICH safety reporting advices * Thorough with project set up, quality assurance, data review, data analysis, database clean up and database closing using data management sy...
Tags for this Online Resume: Pricing, Protocol, Research, Data Entry, Data Management, Management, Project Planning, Quality Assurance, Services, Support
