Pharmaceutical Information Technology Professional with over 20 years of application design, development, testing, and implementation experience. Areas of expertise include implementing systems and processes to help organizations achieve sustained business performance applied locally and on global program basis. Background includes a unique blend of business acumen, technical expertise, and financial discipline which enable...
Ideal Companies: Medco, Barr, Eisai, Becton Dickinson, Roche
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IT, Information technology, IS, Information Systems, Technology, Healthcare, PMO, EPMO, Portfolio Management, Project Management
Over twenty years equipment and process design, installation and testing of process control and automation systems used across various industries the majority of which are pharmaceutical and food; Fortune 100 & federally regulated corporations. Extensive knowledge of multiple PLC platforms, SCADA programming, MSSQL, InSQL, and RSSQL database designs, implementations & management, InBatch, CDC’s & Wonderware’s Overall Equipm...
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Automation, Process Controls, Project Manager, I, Pharmaceutical, Biotech, PLCA, SCADA
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...
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Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
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Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Hi,
I wrote the BEST GUI for Angular 2 Mobile App Frame called SwipeClouds that is SUPERIOR to Ionic – Read My Article About It:
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Previously I developed software for Microsoft as their Director of Live Search Marketing & Software Development. And at MySpace.com I was their Director of Software Development.
I work with the lates...
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jQuery, Microsoft, Microsoft Windows, Blackberry, Hyper Text Markup Language 5, Marketing Management, Project Leader, Video, Security, Software, linux, it jobs, c++, html, agile, c#, software, javascript, java, sql, PhoneGap, HTML5, Angular, Angular4, Angular2, Angular 5, JQuery, Mobile, Java, Objective C, SwipeClouds Framework, Canvas, CTO, Director, .NET, VB .NET, Angular 1.4, React
CAREER SUMMARY An information technology (IT) professional that is passionate in achieving global company objectives. A high energy diversified team player collaborating with and supporting all levels of employees and vendors. Well organized, detailed oriented, flexible and self motivated in implementing and supporting projects while aiming towards results of corporate initiatives. Key areas include: * Data Center Operation...
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Budget Forecast, Budgeting, Disaster Recovery, Forecast, Help Desk, Information Technology, Management, Audit, it jobs, software, agile, html, c#, sql, linux, java, javascript, c++, Hardware implementation
Experienced with MSP applications such as Connect Wise and Kaseya providing comprehensive IT support to small and medium size businesses. * Palantir. O365 Migration Consultant, Palo Alto, CA 4/17 - 7/17 Created documentation to minimize foreseeing users' migration disruptions. Ei, Distribution list, Rooms, Transport Rules etc Worked with Power shell to create Bulk users, Distribution lists, O365 Groups, and place mailboxes ...
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Active Directory, Applications, Blackberry, CFR Part 11, Cisco, Cisco Switches, Database, Database Applications, Dell, Desk Top Support, Netwrok Engineer