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Online Resumes with "21 CFR Part11"
Business Analyst - 14 Years of Experience - Near 60031
System Analyst with significant progressive experience in the IT operations of a world class highly regulated health care company. Possesses solid working background and expertise in programming languages, software development and validation activities, systems database and analysis, operating systems, evaluation of business needs and computer platforms and systems, development and deployment of IT solutions, testing and de...
Tags for this Online Resume: .Net, PL/SQL, Crystal report, C, MS Office, Visio, HP Quality Center
Senior Business Systems Analyst/IT Project Manager - 7+ Years of Experience - Chicago IL
Strategic and innovative Senior Business Systems Analyst/IT Project Manager with over 7+ years� experience leading large scale IT projects. Highly accomplished and forward-thinking, with diverse expertise in IT systems and business systems analysis. Talented senior system analyst and senior business systems analyst with broad IT experience across multiple sectors. Create, design and implement efficient, consistent and strea...
Ideal Companies: Baxter, Takeda, JP Morgan Chase, Citibank, HSBC, Allstate, Bank of America, Standard Chartered, State Farm, Johnson & Johnson, Procter & Gamble
Tags for this Online Resume: Business Requirements to System Design, Laboratory/QA Systems like LIMS, Empower 3, ELN, Atlas, SDMS NuGenesis Configuration/testing, Regulatory Compliance for FDA, EU Annex 11, 21CFR Part11 Compliance, ERP SAP-QM, SDLC/Waterfall/Agile Development Methodologies, Project Management, Custom Software Development, Systems Engineering, System Risk Mitigations/Integrations, Enterprise wide implementation, ROI Analysis, Costing , UAT, System Integration Testing, Performance Testing, Regression testing, Acceptance Testing, Validation Testing Scripting and documentation. GXP, GMP, GLP, GCP, Lean Six Sigma Green Belt expertise, C, Oracle 10g/11g, SQL Server, PL/SQL Stored Procedures, Costing, Project Scheduling, Cross-Functional Supervision, Team Building, Client Relations Presentations, Business/IT Planning, Vendor Management, UML Designing, MS Project, Gantt Chart, MS Office, Rational Rose, URS, FRS, SDD, Installation, Traceability Matrix, BI, Cognos, QlikView, Infomaker Report, MS Test Manager, Sharepoint, Business Operation Excellence, Process Improvement Excellence
Technical Writer
Thirteen years experience in multiple industries at all organizational levels coordinating technical documentation creation and editing while interfacing with Subject Matter Experts, on-site engineers and technicians, and business partners. Currently seeking challenging opportunity.
Tags for this Online Resume: MS Office, Adobe Framemaker, MS Project, Factory Automation, Laboratory, IQ, OQ, PQ, Validation, Commissioning
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Engineer - 19 Years of Experience - Near 33184
Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment
Architect - 11 Years of Experience - Near 08817
PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...
Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script
Business Analyst - 7 Years of Experience - Near 08817
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...
Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project
Chemical Engineer - 14 Years of Experience - Near 77004
SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...
Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation
Team Leader - 9 Years of Experience - Near 08854
Experience Summary * A seasoned analytics and consulting professional with ~9 years of industry experience as a SAS Consultant and Business Data Analyst with a strong understanding of Data Handling and Management, SAS, Project management, and Business Analysis. Project Summary This program supports the in-out of the company's innovative value-based programs. This includes the analyses of business KPIs and financial metrics ...
Tags for this Online Resume: Programming, Support, ETL, QA, Management, Data Extraction, Project Management, Requirements Analysis, SAS, Data Analyst
Quality Assurance Specialist - 20 Years of Experience - Near 80421
Areas of Expertise FDA ISO / IEC Quality Systems Risk Management FMEA V&V Testing Web Application Testing HLM / Quality Center SDLC Qualification Protocols Agile RoHS Compliance
Tags for this Online Resume: Documentation, 21 CFR Part 11, Quality Center, Quality Assurance, Testing, ISO, Validation, Agile, Audit, Compliance, IEC, JIRA, FDA, Software, IQ, OQ, PQ, Medical, FMEA, Functional, Acceptance, Performance, Verification
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
