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Online Resumes with "Part 11 compliance"



Quality On My Mind

Experienced Quality profession dedicated to designing and implementing profit-centric Quality solutions

Ideal Companies: Alcon Labs, Boeing Inc., ASRC, Bayer

Tags for this Online Resume: Quality, Project Management, Software Validation, Product Validation, Corrective Action, Root Cause Analysis, Auditing, Public Speaking

Computer System validation Specialist

An IT professional with over 10 years experience as a validation specialist, senior/lead technical writer, documentation manager, analyst, tester, and end-user trainer. IT experience is complimented by solid management and leadership experience gained as a US Army officer.

Tags for this Online Resume: validation, documentation

Featured Profile

EPMO / PMO Leader

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

Tags for this Online Resume: IT, Information technology, IS, Information Systems, Technology, Healthcare, PMO, EPMO, Portfolio Management, Project Management

Automation & Process Controls Engineer - 20 Years of Experience - Near 27569

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...

Tags for this Online Resume: Automation, Process Controls, Project Manager, I, Pharmaceutical, Biotech, PLCA, SCADA

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

Quality Professional

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...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Computer Programmer - 20 Years of Experience - Near 33156

Hi, I wrote the BEST GUI for Angular 2 Mobile App Frame called SwipeClouds that is SUPERIOR to Ionic – Read My Article About It: https://www.codeproject.com/Articles/1175045/Angular-Mobile-App-with-JQuery-Mobile-Cordova-or-P 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...

Tags for this Online Resume: 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

Director or Manager MIS or IT - 20 Years of Experience - Near 11803

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...

Tags for this Online Resume: 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

Network Engineer - 13 Years of Experience - Near 23188

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 ...

Tags for this Online Resume: Active Directory, Applications, Blackberry, CFR Part 11, Cisco, Cisco Switches, Database, Database Applications, Dell, Desk Top Support, Netwrok Engineer