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Online Resumes with "FDA ICH"
Postsecondary Teacher - 11 Years of Experience - Near 29376
CURRICULUM VITAE: Sharon Woodruff Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills. Work History Title: Senior Clinical Research Associate Company/Location United BioSource Corporation Kansas City, MO/Regional United States Dates July 2014 - January 2015 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and invest...
Tags for this Online Resume: South Carolina, Training, New Hire , Business, Education, Postsecondary, Excellence
Chemist - 20 Years of Experience - Near 78720
Career Summary Quality control and method development for nutrition products. * Project management for government /military funded projects as well as collaboration with sporting goods and chemical industries for prototype product development and marketing technical support. Multi-tasks management, coordinate cross-functional activities between groups and related sub-contractors within project timeline and budgets. * Proto-...
Tags for this Online Resume: Resource Scheduling, Scheduling, Test, Troubleshooting, Budgeting, Clinical Research, Marketing Management, Product Launch, Project Management, Project Manager, pharmaceutical, Sr. Analytical Chemist
Clinical Quality Assurance - 20 Years of Experience - Near 19713
AREAS OF EXPERTISE * Quality Assurance, CAPA * Regulatory Stability Documentation * Quality Systems * Strategic Project & Team Management * Troubleshooting / Problem Solving * Stability protocols, SOP's * USP, BP EUP, JP * FDA and ICH guidelines * Chromatographic Data Systems * Method validation and metrics * Lab Inspections & Evaluations * Product Support / Quality Control * Standard Operating Procedures
Tags for this Online Resume: Stability, Quality Assurance, Data Management, Quality Control, Data Analysis, LIMS, Reference Standard, COA Management, FDA and ICH Guidelines, USP,EUP,BP,JP, HPLC, GC etc., pharmaceutical, protocol, ich
Clinical Research
PROFILE Decisive, action-oriented and results-focused professional offering more than 30 years of experience in the medical field with 23 years focused in clinical research. Thorough knowledge of Medicine. Ability to deal with the public in a professional, concerned manner and ability to convey a sense of confidence and trust to patients and work well with other health professionals. Knowledgeable of FDA, ICH and GCP guidel...
Tags for this Online Resume: ICH, EKG, Research, C Programming Language, Catalogs, Clinical Research, Hematology, Hepatitis, Hepatitis C, Scheduling
Clinical Research - 15 Years of Experience - Near 54901
Summary Seasoned director of clinical operation and project management with over 18 years' experience in local and global CRO and pharmaceutical industry, specializing in phase I, BA/BE start-up operations. Complete and solid understanding of business priorities, genuine team player committed to managing operations and projects efficiently and without flaws, while contributing to revenue producing activities. Serve as a key...
Tags for this Online Resume: Clinical Research, Research, Dermatology, Support, Clinical Management, Documentation, Management, Ophthalmology, Outsourcing, Cardiology
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
