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Online Resumes with "ICH"
Chemist - 13 Years of Experience
SUMMARY OF QUALIFICATIONS: * Strong organizational and technical skills, highly efficient a quick learner. * 13+ Years of experience with Analytical Testing within GMP environment. * Understands and complies to ICH guidelines, cGMP, GLP, and FDA regulations. * Very enthusiastic and motivated in learning new instrumentation and methods. * Work effectively under high pressure environment and never compromise with ethics and q...
Tags for this Online Resume: Quality, Quality Assurance, High Performance Liquid Chromatography (HPLC), Documentation, Instrumentation, Software, Test, Troubleshooting, 5S, Documentum
Clinical Regulatory Affairs - 4 Years of Experience - Near 02494
SUMMARY * Current graduate student working on second master's degree in Regulatory Affairs for acquiring general insights of regulatory profession and in-depth practical knowledge of regulatory compliance, including CMC (Chemistry, Manufacturing, and Controls) and quality system practices. * Extensive background in the biopharmaceutical industry and 3-year experience in upstream bench-scale cell culture process development ...
Tags for this Online Resume: Biopharmaceutical, Biotechnology, ICH, Regulatory Affairs, Manufacturing, Medical Devices, Regulatory Compliance, quality assurance, FDA, EU, Pharmaceutical, GMP
Sr. Clinical Research Coordinator - 14 years Experience -Miami
FMG with 14 years experience working in Clinical Research field from Phase I to Phase IV in multiple therapeutic Areas with vast knowledge of GCP-ICH, Medical Terminology and Regulatory Compliance,Bilingual,Works without supervision or a Team, Detailed and Organized, resolution skills looking forward to join a Pharmaceutical Company to represent it in FL in which my skills can help to enhance the Company Efficacy and Effect...
Tags for this Online Resume: Miami, Florida, Sr. CRC, CRA Entry Level, Study Start Up Specialist, Regulatory Affairs
Medical Scientist - 13 Years of Experience - Near 21136
HIGHLIGHTS OF QUALIFICATIONS: * 2+ years of clinical research monitoring experience and 25+ years pre-clinical experience * Knowledge of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines * Knowledge of FDA regulations * Knowledge of clinical trials for investigative biomedical and pharmaceutical studies. * Good working knowledge of Pharmacology, Epidemiology, Biology, Chemistry, Ph...
Tags for this Online Resume: Cancer, Leadership, Medical, Patient Care, Quality, Quality Assurance, Quality Control, Trauma, Troubleshooting, Phlebotomy
Department Manager - 19 Years of Experience - Near 18901
Tags for this Online Resume: Pharmaceutical, Good Manufacturing Practices, Management, Logistics, Summit, Training, LMS, Quality, Quality Assurance, Compliance, GXP/ DEA, E-Learning, CAPA, Investigations, Auditing, ICH, FDA, EU
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
Project Manager- 10 years experience in Oncology
Tags for this Online Resume: Oncology, GU, eDC, FDA, GCP, ICH
Pharmacist - 9 Years of Experience - Near 75215
Profile 10+ years experience in patient centered healthcare delivery 10 years experience in pharmaceutical dispensing and patient counseling 7 years experience in drug compliance management as part of a multidisciplinary healthcare team. 5 Years experience in Pharmacy Compounding Process and Continuous Quality Improvement 5 year experience in Sterile and non sterile compounding 2 year experience in administration and dispen...
Tags for this Online Resume: Beta Testing, Compliance, Quality, Quality Assurance, Test, Management, Data Analysis, Health Insurance Portability And Accountability Act, Problem Solving, Problem Solving Skills
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Pharmaceutical Scientist
SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosoph...
Tags for this Online Resume: Management, Business Development, Documentation, MOS, Pharmaceutical, Due Diligence, Manufacturing, Packaging, Process Improvement, Quality
Clinical Research - 20 Years of Experience - Near 20882
Summary: Over 16 years managing clinical trials and data collection activities. Manage as Point of contact for sponsors, project teams, and investigational sites to facilitate clinical studies Phase I-IV. Responsible for the review and approval of case report forms, electronic data capture systems, review of protocols, implementing study procedure manuals, and monitoring plans. Additionally manage site selection, study exec...
Tags for this Online Resume: Collection, Quality Assurance, Test, Process Improvement, Project Management, Project Manager, Business Requirements, Clinical Research, Data Entry, Filing
Clinical Research - 14 Years of Experience - Near 77407
I have 5+ years of clinical research experience and I have developed the skills and abilities needed to be a great asset to the clinical research industry. I am seeking for a clinical research monitoring position where I can utilize my site monitoring skills and management experience to positively impact the clinical development campaigns of the client. Ability to travel nationally 80% of the time. I have experience working...
Tags for this Online Resume: Clarify, Clinical Research, CVS, Documentation, Drug Protocol, Good Clinical Practices, ICH, Project Leader, Project Management, Protocol
