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Online Resumes with "Part 11"



Application Support

Tags for this Online Resume: Robohelp, Framemaker, Word, 21 cfr part 11

Featured Profile

IT Professional - Versitle Expertise

IT professional with extensive experience in manufacturing across diverse industry sectors including medical devices and healthcare, non-profits and both mid-size and large companies including a Fortune 500 biotechnology company.

Ideal Companies: Large To Mid

Tags for this Online Resume: RPG ILE, DOS, DOS 5.0, DOS 6.2, Windows 3.0, Windows 3.1, Windows 95, Windows 98, Windows 2000, Windows XP, Windows 7, MS Offfice 2003, MS Offfice 2007, MS Offfice 2010, Lotus Notes, OutLook, Rockwell, Vision Systems, FDA, ISO, CFR 21 Part 11, SOX, Risk Managerment, Visual Basic, Avaya, MS Server, Rumba, AS 400, PEAK, RF, REMEDY, Peregrine, Project Management, KBO, KPI, SLA, SOA, Asset Manaagement, Manufacturing Support, Crisis Management, On Call, Remote Access, SMS, Travel, Relocation, Health Care, Distribution, Global, SDLC, Security, Flexibility, Customer Service, Automation, CLP, Diasaster Recovery, IBM, Contracts, Billing, Finance, Human Resources, Research Development, Testing, Validation, KeyTroller, Network, M-LAN, Anti Virus, Operating System, Wireless, Laptop, Desktop, Support, Acquisition, Outsource, Help Desk, Service desk

Compliance Manager/Auditor

To obtain a position working as a Microbiology Business Analyst and Project Manager in a pharmaceutical/biotech validation environment, oriented toward management advancement. Over 20 years of experience in the Pharmaceutical Industry, 16+ years of those years are with GxP (GMP, GLP, GCP) systems compliance/QA and 21 CFR Part 11. Experience includes GxP system implementation projects, documentation/SOP writing/review.

Project Manager

Edward Koza, Jr. 10 Whittier Road Clark, NJ, 07066 Home - (732) 381-4389 Cell ā€“ 732-694-9073 E-mail ā€“ edjet21jr@hotmail.com Re: Sr. Manager/Asst. Director Prior to the sale of the Pharmaceutical Technologies & Services, a division of Cardinal Health I was Director of the Global Application Support Team. Together we were responsible for 528 applications that made up of the main ERP applications, SAP (for Distr...

Tags for this Online Resume: 21CFR Part 11, GXP GMP, Sox FDA, SiX Sigma Green Belt, PMBOK, Oracle/ SAP

Sr. Quality Engineer, 20 years FDA regulations, CQA, Midwest

Sr. Quality Assurance Engineer with twenty years quality experience complying with FDA regulations. Energetic team player supporting quality within all manufacturing operations.

Tags for this Online Resume: Quality Engineer, CQA, Risk Management, Quality Systems , FDA, 21CFR Part 11

Regulatory Pharmaceutical Document Specialist and Technical Writer

Brenda is a Technical Writer and Quality Assurance Regulatory Document Specialist with over ten years of experience in the pharmaceutical industry. She has extensive experience with all types of document project work, including writing, editing, formatting. She has experience as a team member for non-conformance investigations (NCs) and Corrective Action and Preventative Actions (CAPAs). Her analytical and research skil...

Lotus Notes Domino Developer

A dynamic, logical thinking, performance driven IT professional, with 15 years of experience out of which fourteen years of Lotus Notes Development including 5 years of Business Analysis experience and one year of Lotus Notes Administration experience using Notes version 7.01 & Notes version 8.4. Possess full knowledge of Software Development process including requirements definition, prototyping, Proof of concept, design,...

Software Engineer

Tags for this Online Resume: SDLC, Agile, Scrum, Java, Project Management, Oracle, 21 CFR Part11, GCP, HIPAA, HL7, Software Architect , CTO, Healthcare, Clinical Research , Offshore Development, Open source technology, EDC, RDC

Project Manager specializing in infrastructure technology

Project Manager specializing in infrastructure related projects and complex implementations. Comprehensive knowledge working within defined System Development Lifecycles

Ideal Companies: google

Tags for this Online Resume: Project Management, Operations Management, SDLC, Regulatory Compliance, CFR 21 Part 11, ITIL, CGMP

Sr. Mechanical Designer - 12 years experience

Energetic, experienced Mechanical Designer working with talented staff engineers for medical device industry. Able to produce highly accurate 3D CAD Models for design layouts and detail drawings using SolidWorks or SDRC. Designs include machining, sheet metal, welded assembly, robotics, fluid and gas delivery systems and solid electrical back ground. Experienced with setting up electronic Doc Control process for complia...

Chemist

I have 14 years of experience in pharmaceutical industries. Results oriented individual with a track record of instituting and maintaining high levels of Quality Assurance and leadership. Iā€™m seeking additional opportunities for professional development in consulting, validation, compliance or technical areas. Strong analytical and planning skills. Six Sigma Black Belt trained. Knowledge in FDA, cGMP, GLP, 21 CFR - Part 820...

Ideal Companies: Pharmaceuticals or food industries

Tags for this Online Resume: qa, validation, lims, qc

Design/Develop/Sell/Manage/Travel

Outgoing personality with strong ability to solve changing business/industry needs with application/database development. Versatile, independent thinker with team attitude.

Ideal Companies: HP, IBM, IT SERVICES COMPANY, LOOKING TO MOVE INTO IT SALES

Tags for this Online Resume: JAVA, JSP, MySQL, SQL, SAS, Database, Programming, SQL Server, ACCESS, Microsoft Office, Web Development, Design, Development, Web, TERADATA, UNIX, PROGRAMMER, ORACLE