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Online Resumes with "GxP GMP "



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 – 732-694-9073 E-mail – 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

Featured Profile

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