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Online Resumes with "Part 11"
Validation Consultant-18 years experience in cGMP regulated environment-Dallas, Georgia
Technically accomplished, results oriented professional with 17 years CFR Part 11and GAMP 5, Part 58, Parts 210 & 211, Part 600, 601,610, Part 1270, 1271and Part 820 cGMP regulated environment with 10 years working experience writing, developing and executing validation protocols, managing calibration programs, maintaining and upgrading automated systems in a cGMP environment. Creative Metrologist/Chemist/Biologist and (IQ,...
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Project Manager - 10 Years of Experience - Near 07901
Ms. Marilynn Goldsmith is a PMI certified Project Manager. Her experience includes projects in integrated oil, insurance, and pharmaceutical sectors. She has been responsible for the project schedule, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables.
Tags for this Online Resume: SDLC, Offshore Teams, MS Office, Deliverable , Validation, Quality, Team Mgmt, Issue/Risk, Management, Oracle, Database, Documentation, Oracle Database, PWC, Requirements Definition, SEC
Senior Process Validation Lead
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
Manager - 13 Years of Experience - Near 46037
Sr. Manager with 5 years’ experience managing individual contributors and supervisors in a global environment Proven Quality Assurance leadership skills to ensure IT/Lab/Site compliance with internal procedures and regulatory requirements Demonstrated ability to successfully lead continuous improvement initiatives with effective planning and organization skills • Lead CAPA Investigations • Host FDA/CAP/DOH/Client Audits ...
Tags for this Online Resume: CAPA, 21 CFR Part 11, SDLC, Metrics, FDA, Quality, Validation
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
Clinical Quality Assurance - 20 Years of Experience - Near 34474
I am looking for a small company that wants to bring their medical device projects and designs through the FDA requirements up to and including sales and Post Market Surveillance. Start ups I believe, are the best projects to bring to market. Each one has a purpose, a validated effort, and an outcome for the employee to learn many activities and wear many hats.
Tags for this Online Resume: Tampa Bay, Jacksonville, quality Manager, Medical devices, FDA expertise, ISO expertise, Part 11 compliance, R
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
