CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "GxP"

Quality Assurance Specialist - 16 Years of Experience - Near 08742

PROFESSIONAL SUMMARY * Experienced and Senior Software Test Engineer for web and mobile applications, communication systems and IP telephony networks * Highly proficient in creating end to end test strategies including the creation and executing of regression test plans, working with developers to create and execute integration test strategies, and interfacing with customers to test on site and resolve customer specific iss...

Tags for this Online Resume: Integrate, Integration Testing, Test, Troubleshooting, Automation, Documentation, Regression Testing, SDLC, Test Plans, Test Scripts, Quality Assurance

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Microbiologist - 20 Years of Experience - Near 45066

Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...

Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures

Architect - 11 Years of Experience - Near 08817

PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...

Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script

Business Analyst - 7 Years of Experience - Near 08817

Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...

Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project

Director of Quality - 15 Years of Experience

SUMMARY Certified Quality Auditor for Life Science Practice Lead as senior Quality System Auditor with compliance acumen delivering outstanding returns through comprehensive knowledge and hands on experience. Vendor qualification and management plus remediation efforts ensuring delivered products meet requirements for direct to stock fulfillment. Certified Quality Auditor/Project Manager for Quality Management Systems for m...

Tags for this Online Resume: Audit, Quality, Quality Assurance, Services, Test, Compliance, Infrastructure, Management, Risk Management, Training

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

Clinical Quality Assurance - 15 Years of Experience - Near 27513

Summary * More than eight years of Quality Assurance (QA) and regulatory experience abiding by GCLP, GLP, GMP, ISO/IEC 17043, GxP, and HIPAA. * Excellent problem solving, risk analysis and organization skills * Strategic thinker with strong interpersonal skills * Able to initiate and complete assigned tasks, work independently, and maintain team orientation skills * Professional, flexible and creative

Tags for this Online Resume: Standard Operating Procedures, Quality Management Plan, Quality Assurance, Internal, in-process, External, Vendor Audits, ISO, Word, Excel, Power Point, Study-Specific Plans, Good Laboratory Practices, Good Manufacturing Practices, Quality Assurance Training

Laboratory Technician - 20 Years of Experience - Near 27502

Detail-oriented, business-focused, and dedicated pharmaceutical business professional with comprehensive background in business management, complimented with hands-on knowledge in project and personnel management in research environments. Exemplify impeccable work ethic, an optimistic “can-do” outlook, and exemplary ability to manage multiple tasks and quickly adapt to challenging and diverse work environments. Exhibit a ke...

Tags for this Online Resume: pharmaceutical, project management, operations management , GXP, MBA, NC, Risk Management, Process Improvement

National Guard - 20 Years of Experience - Near 72120

 Over 23+ years of experience within the intelligence community (IC) providing high quality results in challenging hostile assignments both CONUS and OCONUS  Active Government Top Secret Clearance/Sensitive Compartmented Information (SCI)  Expert Imagery Analyst, flight mission planning, and employing intelligence capabilities and assets  Readily worked 12-15 hour shifts under pressure while multi-tasking in hostile e...

Tags for this Online Resume: hard worker, dependable, Socet GXP, skilled Analyst, great attitude, flexible, Radar, Sar, Support, A SERIES

Business Systems Analyst

Summary Jim possesses excellent analytical and problem solving abilities with strong interpersonal and communication skills. Fifteen years of experience in developing and supporting GxP applications in highly regulated environments, provides him a clear understanding of how FDA and Quality Regulators, look at documentation and process controls. He brings accountability, integrity and a dedication to quality standards, to th...

Tags for this Online Resume: Budgeting, Integrate, Management, Planning, Quality, Quality Assurance, Quality Management, System Integration, Systems Analyst, Applications

Clinical Research

Summary . Research Scientist with experience on and off the bench in a GxP environment. Extensive experience with R&D, assay development, clinical testing documentation, compliance, managing regulated equipment, overseeing lab moves and modifications, change controls, SOPs, Validation and Qualification protocols internal audits, project management *

Ideal Companies: regeneron, pfizer, siemens

Tags for this Online Resume: Ariba, Asset Management, Compliance, ELISA, Genotyping, High Performance Liquid Chromatography (HPLC), Immunization, Inventory, Inventory Control, Management