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Were you looking for Part-11 job results?
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Online Resumes with "Part 11"
Engineer - 19 Years of Experience - Near 33184
Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Biologist - 13 Years of Experience - Near 07208
Qualifications Summary Highly competent, diligent, and detail-oriented management professional, equipped with extensive experience and expertise focused on various areas of quality improvement, process validation and qualification, manufacturing, risk analysis, as well as implementation of standard procedures and policies within the pharmaceutical industry. Possess solid instrumental analysis skills and expertise in categor...
Tags for this Online Resume: Management, Complaints, CFR Part 11, High Performance Liquid Chromatography (HPLC), FDA, New Jersey, MSDS, Policies and Procedures, Process Improvement, Protocol, CAPA
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
Chemical Engineer - 14 Years of Experience - Near 77004
SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...
Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation
Team Leader - 9 Years of Experience - Near 08854
Experience Summary * A seasoned analytics and consulting professional with ~9 years of industry experience as a SAS Consultant and Business Data Analyst with a strong understanding of Data Handling and Management, SAS, Project management, and Business Analysis. Project Summary This program supports the in-out of the company's innovative value-based programs. This includes the analyses of business KPIs and financial metrics ...
Tags for this Online Resume: Programming, Support, ETL, QA, Management, Data Extraction, Project Management, Requirements Analysis, SAS, Data Analyst
Quality Assurance Specialist - 20 Years of Experience - Near 80421
Areas of Expertise FDA ISO / IEC Quality Systems Risk Management FMEA V&V Testing Web Application Testing HLM / Quality Center SDLC Qualification Protocols Agile RoHS Compliance
Tags for this Online Resume: Documentation, 21 CFR Part 11, Quality Center, Quality Assurance, Testing, ISO, Validation, Agile, Audit, Compliance, IEC, JIRA, FDA, Software, IQ, OQ, PQ, Medical, FMEA, Functional, Acceptance, Performance, Verification
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Business Analyst - 14 Years of Experience - Near 20850
Tags for this Online Resume: System Security, Test, Test Scripts, Application Development, CFR Part 11, Configuration Management, Configure, Management, Monitoring, Protocol, Quality Assurance
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Quality Assurance Specialist - 13 Years of Experience - Near 94506
SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....
Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis
