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Online Resumes with "ICH "
Biochemist - 18 Years of Experience - Near 84037
Compliance and Quality Manager in Pharmaceutical manufacturing. Highly experienced with Aseptic, Solid Dosage, and Liquid Manufacturing including 15+ years in management. Key player in successful Regulatory relationships with Inspectors across 4 continents. Developed and implemented Quality systems, processes, procedures, and policies. People acumen across all levels from executives to entry-level.
Tags for this Online Resume: Quality, Compliance, Quality System, Standards (GMP, GLP, GCP, ICH, ISO, WHO, CE, Med Device), Training, Investigations (CAPA), Documentation, Salt Lake City
Clinical Pharmacovigilance/Drug Safety - 7 Years of Experience - Near 94116
Tags for this Online Resume: neurology, medical, ICH-GCP, FDI, SOP, clinical trials, adverse event, analytical
Clinical In-house Monitoring - 1 Years of Experience - Near 19131
My number one objective is to get monitoring experience and become a CRA. I hope to specialize in Oncology, but I am open to other therapeutic areas. I want to become a clinical trial manager one day and down the road, with years of experience, I hope to obtain my PMP certification.
Tags for this Online Resume: Clinical Research, ICH-GCP, EDC, Clinical Monitoring, Oncology, Source Data Verification, PMP, ACRP
QA
Cover Letter Ignace Vallejo, MS. GCP and GMP QA Manager Certified Quality Auditor GMP; by CFPA. Certified Six Sigma “Black belt”. 525 Neptune Ave, Brooklyn, NY 11224. Apt 22 F Home # 718 946 0556. Mobile # 917 359 3028. ignaciovallejo@optonline.net Good Clinical Practice (GCP). Audits were followed according to our SOPs and ICH GCP regulations and Guidelines. The vendor audits were preformed, as follows: • On Octo...
Tags for this Online Resume: Quality Assurance, Scientist, Trainer, Quality Control, Auditor, Biology, Quality, Manufacturing, Management, Microbiology
Formulation Scientist, Bay Area
Highly accomplished R&D professional with over 17 years of cumulative Analytical, Formulation and Management experience. Technical background includes recognized strengths in development of high concentration, stable liquid and lyophilized drug product formulations, biophysical and chemical characterization, Life Cycle Product Management, and compatibility studies for Preclinical Dose Administration. Experience includes des...
Tags for this Online Resume: Formulation Scientist, Fusion Proteins, Monoclonal antibodies, Liquid formulations, Lyophilized Formulations
Clinical Research - 7 Years of Experience - Near 08820
Tags for this Online Resume: Clinical Monitoring, Prestudy visit, Study closeout, SOPs, Ich Guideline, FDA requirement, Study documents
Chemist - 20 Years of Experience - Near 92656
Chemist with extensive experience in the pharmaceutical, oil and cosmetic industries. Quality assurance in manufacturing environment. AREAS OF EXPERTISE • Proficient in c’GMP, Analytical chemistry, Quality Assurance • Stability testing, analytical method validation, quality control (QC) and other laboratory activities within ICH and FDA compliance guidelines • Empower, Chromeleon, Chem-Station, Nugenesis, Trackwise, Ele...
Tags for this Online Resume: RD, HPLC, UPLC, Empower, CHROMELEON, CHEMSTATION, Method Validation, Stability
Clinical Research - 8 Years of Experience - Near L7A0S
Looking project manager, study manager or clinical research associate job
Tags for this Online Resume: Oncology, Heamatology, clinical trials, ICH guidlines ,Sop'S, transplant, Management, Infectious diseases
Clinical Research - 1 Years of Experience - Near 74023
Matthew Thomas Marcum 3220 N. Ruth Avenue • Cushing, OK 74023 mmarcum1@jhu.edu 918-225-2977 Dear Sir/Madam, I am a recent graduate from Johns Hopkins University (cum laude) with an M.S. in Biotechnology who is currently seeking a challenging and exciting career within the Clinical Research sector. Moreover, I possess a robust education in drug discovery and development, clinical trial design, clinical ethics, Good Clinic...
Tags for this Online Resume: Clinical Research Associate, Clinical Research Monitor, Tulsa, NAPSRx, Pharmaceutical Sales, Clinical Trial Assistant, Oklahoma City, GCP
Featured Profile
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume:
Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
Scientist - 11 Years of Experience - Near 11779
Analytical method development by using Quality by Design approach. Risk analysis, FMEA, Control strategy and mitigation plan during the analytical methods development.
Analytical method Validations as per ICH. Stability studies as per the product requirement.
Tags for this Online Resume:
Analytical method development, HPLC, GC, ICH, QbD, DoE, FMEA
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
