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Online Resumes with "System Validation"
RESEARCH AND TECHNICAL PORTFOLIO MANAGER
Accomplished international partner collaboration project and program manager with over 30 years of experience directing and mentoring teams to exceed technical and business objectives. Solid track record of delivering complex research and development projects on-time and within budget. Strong analytical and strategic skills leveraged to develop and execute long-range plans across departments, organizations, and countries. S...
Ideal Companies: GE, NRG, Boeing, LockheedMartin
Tags for this Online Resume: Aerospace, Architect, Business Development, International Sales, Product Development, Sales, Training, Documentation, Management, Program Management, Research, Research Portfolio, systems engineering, space systems, requirements managemetn, stakeholder relationships, process improvement, integration, International Relations, Anthropometry, Ease of use
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
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
System Engineer - 20 Years of Experience - Near 15143
SKILLS SUMMARY * Achievement-oriented professional with expertise in Systems Engineering Project Life Cycle including analysis, design, implementation, development, testing, validation and verification, quality Control, and systems configuration control and release. * Expert knowledge and analytical skills for mathematical modeling and systems simulations of large scale systems with multi-objective optimizations. * Excellen...
Tags for this Online Resume: Consulting, Defect Tracking, Embedded Systems, Software, Software Development, Management, C++ Programming Language, Data Processing, Automation, Clearcase
Aerospace Engineer - 10 Years of Experience - Near 79928
Areas of Expertise Technical Skills CATIA V5 MatLab C++ AutoCAD Arena Simulations PLC Programming Siemens NX Android MS Office Windows OS MacOS Solid Works System Validation Project Management Quality Control Mathematical SAE Aerospace Standards Problem Solving Scope and Timeline Planning and Forecasting
Tags for this Online Resume: Standard Regulations, Aerospace, CATIA Version 5, Stress, OSHA, FAA, Policies and Procedures, Quality, Verification and Validation, Engineering, Design
Clinical Research
Areas Of Expertise * Good Clinical Practices * QC/QA Audits * IRB Submission/Standards In-House Monitoring * TMF Subject Matter Expert * eTMF System Validation Research Site Management * Cross-Functional Collaboration * Clinical Operations
Tags for this Online Resume: TMF, eTMF, CCRP, Site Management, Informed Consent, GCP, Document Management, IRB, Clinical Operations, Regulatory, Contracts, Budget
Microbiologist - 6 Years of Experience
Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...
Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language
Network Engineer - 8 Years of Experience - Near 2760
Community service and Professional development Career Interest My research area includes Distributed Intelligence Systems, Intelligent Controls, Temporal and Spatial Modeling, Planning of Discrete Event Systems, Validation and Verification of Architectural Rule-based Systems, with respect to Wireless Networks and Image compression processing as well as Petri Nets Design for computing networks. Intended synopsis Internet of ...
Tags for this Online Resume: Networking, Research, Security, Engineering, Accenture FOUNDATION, Business Development, Cisco, Cisco Certified Network Associate, English Language, First Aid
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
Key Acccount Manager - 20 Years of Experience - Near 48329
Areas of Expertise: * (7+) Years of account management/business development/sales experience focused primarily in the electric vehicle & automotive /transportation vehicle arena, the industrial/commercial sensor markets in the oil & gas, petrochemical, HVAC, & special hazard safety system environments. * (3+) Years on-site at the GM Orion Assembly Plant, as a Production Process Analyst/PFMEA Specialist delivering critical t...
Tags for this Online Resume: Quality, Manufacturing, Business Development, OEM-Tier One, Switches-Sensors, Engineering, Facilitator, Purchasing, Audit, Switches
Quality Assurance Specialist - 14 Years of Experience - Near 34685
Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...
Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall
Clinical Data Management - 1 Years of Experience - Near 02176
SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported...
Tags for this Online Resume: Documentation, CFR Part 11, Management, Test, Test Scripts, Data Management, Hematology, User Acceptance Testing, Acceptance Testing, Change Control
