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Online Resumes with "GMP GLP"

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Electromechanical Equipment Assembler - 1 Years of Experience

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control

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

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

Medical & Clinical Laboratory Technician - 5 Years of Experience

CAREER SUMMARY Over 10 years of experience in Bio Safety level 2 labs, familiarity with GMP, GLP and lab SOPs, drug-development processes and expertise and exposure to cell fluorescent assays, PCR techniques and cell-molecular techniques a detail-oriented self-starter seeking to expand professional horizons by leveraging gained skillsets aboard a dynamic, multi-faceted team to achieve sophisticated research project goals in...

Tags for this Online Resume: COLI, Electrophoresis, Protocol, Western blot, Cancer, Construct (App Dev Tool), Good Laboratory Practices, Good Manufacturing Practices, Microbiology, Research

Microbiologist - 4 Years of Experience - Near 40220

Summary of Qualifications: * More than 3 years of experience in field of microbiology, molecular biology and bacteriology * In depth knowledge of laboratory techniques and equipment * Expertise in DNA, RNA extraction-purification, and gene expression * HACCP, GMP and GLP trained * Extensive experience in PCR, agarose Gel electrophoresis, and Spectrophotometry * In-depth knowledge in Fermentation and Industrial Biotechnology...

Tags for this Online Resume: Microbiology, Biotechnology, Electrophoresis, Good Laboratory Practices, Good Manufacturing Practices, PDF, Publications, Quality, Quality Assurance, Quality Control


Dedicated and Strategic QA Professional with more than fifteen years of progressive experience in both large and small pharmaceutical companies both US based and international. Extensive experience in development through commercialization of solid oral dosage products. Comprehensive knowledge of cGXP and ICH guidelines. Leader of process and manufacturing compliance, document control programs, QA analytical sciences, vali...

Tags for this Online Resume: Internal and External Audits, Vendor Management, Quality Systems, CAPA, Customer Complaints, Chemistry Machine Control

Clinical Regulatory Affairs - 20 Years of Experience - Near 55311

Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...

Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications

Biochemist - 15 Years of Experience - Near L4J 7

Summary 5 years of biotech scientist in Canadian pharmaceutical industry, 10 years of academic research experience in US and Canada, 4 years of medical executive in a US-owned biotech company in China . Identification, Verification and QC analytical tests following cGMP or GLP * Perform Quality procedures such as Change management, Deviation investigation etc. * Calibration and validation of data and instruments * ELISA bas...

Tags for this Online Resume: Research, Management, Medical, Protocol, Banking Industry, Biotechnology, Clinical Research, Construct (App Dev Tool), Dec, ELISA

Chemist - 11 Years of Experience - Near 30904

Professional Summary Pharmacist with doctorate degree in analytical chemistry with hands on experience in analytical method development and its validation. Expertise in material chemistry (sol-gel chemistry) and column technology. Have skills and ability to operate wide range of analytical instruments and have basic knowledge of GMP, GLP, 21 CFR Part 210, 211 and validation studies. Currently working in a pharmaceutical ind...

Tags for this Online Resume: Chemistry, Inventory, Pharmaceutical, Regulatory Affairs, Analytical Chemistry, Good Laboratory Practices, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Instrumentation, Its

Quality Engineer - 10 Years of Experience - Near 95127

SUMMARY Career highlights include building and directing a QA/QC function, Analysis, Testing, SPC project, Internal auditor in PWB high tech industry and Rechargeable Batteries of new technology (10+ years), Testing/Diagnose network systems to board level (5+years) & managing Analytical Labs in Food industry and Water Supply Sources (10+ years). Influenced on key committees and entrusted to manage the most confidential and ...

Tags for this Online Resume: Experience Auditor, Management experience, QA/QC profesional, Internal audit teamplayer, Microsoft Access profesional, Cisco system testing, Data Analysis Expert, Microsoft Excel professional, Microsoft Office profesional, NCR

Pharmacist - 5 Years of Experience - Near 08854

Profile A dedicated analytical chemist with total 5+ year of experience. one+ years' experience in the field of Pharmaceutical & analytical laboratory, two years' experience as teaching assistant and one+ years' experience as University laboratory research, 6+ months' experience in the field of Pharmaceutical R&D department. Summary * Applied GMP/GLP in all areas of responsibility, as appropriate * Performed laboratory oper...

Tags for this Online Resume: Laboratory Work, Chemistry, Inventory, Management, Purchasing, Support, Technical Support, Bonds, Analytical Chemistry, API