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Online Resumes with "CFR 21 Part 11"



QA/RA Manager / Senior Quality Engineer

I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.

Ideal Companies: New Start-ups

Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program

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

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

Business Technology Analyst, Carolina and Guayama Puerto Rico

Luis A. Jiménez Silva Tel. (787) - 653-6759 Home or Mobile 787-662-5229 E-Mail: luisjimenez0710@yahoo.com Skype ID: luis_jimenez_silva111 OBJECTIVE: I am seeking a challenging and opportunity position in Quality System Manage...

Tags for this Online Resume: Office Management, Green Belt, Project Management, LIMS Administrator, Process Supervisor, Quality System Validation

Manager - 20 Years of Experience - Near 02343

Tags for this Online Resume: CFR 21 Part 11, Product Data Management , Documentation Management , Change Control , Process , SOP

Timing Device Assembler, Adjuster, or Calibrator

Tags for this Online Resume: Mechanic, maintenance, packaging, Manufacturing, pharmaceutical, FDA, cGMP, CFR 21 Part 11

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

Quality Assurance Specialist

Tags for this Online Resume: Security, Networking, Compliance, Information Security, Microsoft Windows NT, Policies and Procedures, Servers, Configuration Management, Configure, IT Risk and Compliance, CFR 21 Part 11

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