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Online Resumes with "cGMP"
Medical or Health Services Manager - 10 Years of Experience
Summary * 10 years of work experience in Clinical Data Management * Currently serving as Data Team Lead in global studies and also as an Associate Manager in Clinical Data Management. * Possess the ability to adapt to any situation and work well with others through effective communication and interpersonal skills Experienced with data management tools processes and therapeutic areas * Responsible for leading the DM team and...
Tags for this Online Resume: Support, Team Lead, Business Development, Data Management, Financial, Financial Management, Management, Pricing
In Between - Near 73301
Summary Quality professional committed to implementing Lean Six Sigma and Business Innovation methodologies through the implementation of various constructive procedures, intricate data analysis, and continuous exceled performance. Always improving upon ways to increase customer satisfaction and product quality reassurance for the consumer. Proficient in generating reports from statistical data analysis, along with familiar...
Tags for this Online Resume: Chemistry, Financial Industry, Inventory, Research, View (Db W/Vsam Ims Db2), Applications, Benefits, Data Analysis
Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta
Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results. PROFESSIONAL SNAPSHOT: •A Quality Assurance Professional bestowed with 10+ years of experience in Corporate Quality Assurance, Plant Quality Assurance, Manufacturing, Validation and different International Quality audits in Solid Dosage. •Hands on experience with Quality Manage...
Tags for this Online Resume: QMS, Batch Record Review, Preparation of SOP, CAPA, Investigation, Change Control, Deviation, Internal Audit, Document Control, Batch Release, Solid Dosage, Process Validation, APQR, Market Complaint, GMP, OOS, Self Inspection, Third Party Audit
Production Supervisor - 18 Years of Experience - Near 90041
Summary Qualified manufacturing supervisor with 10 years production experience, professionally skilled in leading high productive team, using lean manufacturing principles to reduce cost and increase process efficiency. In-depth knowledge of cGMP regulation and FDA compliance. Dedicated leader with demonstrated ability to train, manage and motivate team members to achieve organization goals and objective. Accomplishments Pl...
Ideal Companies: A growing or prominent biopharmacuetical company. Gilead, Amgen, Roche, Kite, Novartis
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Inventory, Manufacturing, Corrective Actions, Lean Manufacturing, Production Planing, ISO 8 environment, Chaired Daily QIT meetings
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
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Director - 2 Years of Experience - Near 01440
Profile PROCESS MANAGEMENT SIX SIGMA INDUSTRIAL ENGINEERING MANAGEMENT WAREHOUSE MANAGEMENT DISTRIBUTION OPERATIONS MANAGEMENT Recognized as a hands on engineering, logistics and operational managing expert. Offering thirty years of accomplishments leading to increased profitability and superlative service delivery. Experienced in multi-unit management. * Proactive and results driven. Operational leadership with vision for ...
Tags for this Online Resume: Planning, Forecasting, Distribution, Policies and Procedures, Security, Housekeeping, Inventory, Management
Principal Engineer
SUMMARY OF QUALIFICATIONS * Principal engineer, R&D and general management executive and scientific professional with B.S. M.S., Ph.D. and postdoctorate in science and engineering disciplines. * Successfully developed several prototypes and launched multiple FDA/CE regulated platforms, devices and Class I-II-III products and plastic consumables for medical, diagnostics, biotech and pharmaceutical applications from concept t...
Tags for this Online Resume: Orange County, CA, Medical Device, Research and Development, Principal Engineer, Manager and Director, FDA and CE regulated, Ph.D., Biotech
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Chemist - 11 Years of Experience - Near 27104
Adaptability, well-developed interpersonal communication skills, creativity, perceptive problem-solving ability, and a driven work ethic are skills that I offer to a prospective employer. Through industrial and academic lab experience, I gained invaluable Quality Assurance experience, which, as a proficient writer, can add to the productivity of an organization. I am a dependable team member or proficient as an independen...
Tags for this Online Resume: Diagnostics, Derivatives, Filing, Neurological, Assessments, Best Practices, C Programming Language, Chemistry, Consulting, HYGIENE, Chemist, Organic, Researcher, Nucleosides, Synthesis, Spectroscopy, Spectrophotometry, HPLC, GC-MS
Biological Technician - 15 Years of Experience - Near 94547
Obtain a challenging position to utilize 15 years of experience in the biotechnology industry. Help company achieve optimum operational excellence while producing successful results in lean manufacturing. Increase process efficiency with a focus on safety. Skilled professional to achieve success and increase productivity in a quality controlled safe cGMP environment
Ideal Companies: BioMarin
Tags for this Online Resume: Biotech, cGMP, FDA, AsepticTechnique , ISO, SAP, Quality Control, manufacturing, Compliance, Monitoring
Chemist
QUALIFICATIONS * Currently working toward the Regulatory Affair Certificate. * Extensive analytical characterization and data interpretation skills. * Experienced in very different analytical tests like Assay, Release Rate, Residual Solvents, Water Content Determination, and ID by IR, and Viscosity Testing. * Expert in handling different analytical apparatus like HPLC, GC, FTIR, UV-VIS, Karl Fisher, Colorimeter, pH meter, L...
Tags for this Online Resume: Good Manufacturing Practices, Manufacturing, Compliance, Inventory, Microbiology, Research, Quality Assurance, Test, Chemistry, High Performance Liquid Chromatography (HPLC)
