Andrey Chudny Email and Phone Number
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24 years of IT experience with emphasis on system administration, application support, workflow development, reporting, project management and regulatory compliance. 15 years of recent experience with Document Management and Quality Systems. Extensive experience in Qumas, TrackWise, Veeva and Crystal Reports.Over 11 years of experience in pharmaceutical industry, knowledge of GxP regulations.Databases: MS SQL, Oracle, JD Edwards and MS Acess.Reporting tools: Crystal Reports, ComplianceUnity, WebFOCUS.Applications: MS SQL Server Management Studio, TrackWise, TrackWise Digital, Qumas, SharePoint, MS Visual Studio, MS Office, DreamWeaver, Adobe DesignerLanguages: SQL, PL/SQL, Stored Procedures, JavaScript, ASP.NET, Java, C/C++, HTML, XMLWorking knowledge of database and reports development, administration, process management, requirements analysis and data flow. Excellent customer service including product support, client consultations and technical writing.Master degree in Management of IT.Sparta Systems certification.
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Senior Information Technology EngineerNovavax Inc Jul 2020 - PresentGaithersburg, Maryland, UsAdministration, configuration and develpment of Qumas application in GxP environment to support research and development of Covid vaccine. Actively managed service desk with over 1,500 users. Participated in report development and QA functions. -
Senior Delivery ConsultantSparta Systems / Zenovative Solutions Apr 2019 - PresentFull life cycle installation and configuration of TrackWise Digital processes including Complaints, Change Control, Deviations, CAPA and others. The projects are performed independently and include new installations, development, configuration and maintenance. Active engagement with client workforce groups throughout the whole project using Agile methodology. Strong knowledge in gathering functional and user requirements, documentation and validation.
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Trackwise ConsultantUsdm Life Sciences / Bard Dec 2018 - Jun 2019USDM Life Sciences is the leading global technology consulting firm focused on digital transformation, regulated and unregulated data management and compliance solutions for the world’s leading and emerging biotechnology, pharmaceutical and medical device companies.As a TrackWise Consultant, I’m responsible for advancing data management through TrackWise including Product Complaints and helping to digitally transform life science and healthcare companies into super efficient, data compliant organizations
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Team LeadAbbvie Pharmaceutical / Tcs Jun 2018 - Dec 2018Quality systems support in GMP production environment.As a MSP provider, actively managed, supported and provided solutions for TrackWise application for over 3,500 users. Managed TrackWise Support Team for incident resolution, accounts creation and various administration tasks. Followed Agile model for Computer System Validation and compliance.Managed, modified and delivered standard and ad hoc Crystal Reports in various formats for TrackWise applications. Actively used ServiceNow application for ticket management.
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Qa SpecialistTakeda Pharmaceuticals Oct 2015 - Jun 2018Tokyo, JpQA Compliance Specialist, TrackWise Administrator and Report Developer at Oncology and Biologics branch, QA department. Serve functions as a Business Administrator and Subject Matter Expert for TrackWise system and Crystal Reports development. Perform change control, compliance, testing and help desk functions.Develop internal KPI metrics, weekly, ad hoc and standard reports using advanced functionality in Crystal Reports application. -
Trackwise SpecialistBoehringer Ingelheim Jul 2015 - Sep 2015Ingelheim Am Rhein, Rhineland-Palatinate, DeProvided consultant services for TrackWise "Carve Out" project at Boehringer Ingelheim's Roxane Labs facility. The system was split according to the client's requirements in a validated environment.Managed the project's offshore resources, company's validated documentation and communication with the client. Performed TrackWise new installation, data migration, configuration and workflow modifications. -
Crystal Reports DeveloperFannie Mae Jan 2015 - May 2015Washington, District Of Columbia, UsActively involved in SAM DataMart system upgrade project that combined data residing in different sources into a central warehouse location for reporting and data analysis. Performed routine maintenance, development and testing of Operational and Business reports in three parallel environments using BI tools. Managed development and production Crystal Reports. Developed and supported SQL code and procedures on Oracle database using Toad. Scheduled and run migration tasks and ad hoc reports. Close interaction with QA, business users and testers. Gathered requirements and maintained documentation for internal compliance. -
Trackwise SpecialistBiogen Idec Sep 2014 - Jan 2015Cambridge, Ma, UsConfiguration, development and administration of TrackWise production workflows in a GxP regulated and validated environment. Utilize TrackWise version 8.3 on Oracle database. Worked closely with Sparta consultants on building and implementing 2 new workflows. Used TrackWise migrator, import utilities and batch record upload for new project implementation.Developed IT Quality validated documents using best business practices and SOPs. Followed full lifecycle document validation and integration procedures. New project workflows included user and functional requirements, design specifications, risk assessment, impact analysis, traceability matrix, configuration specification, test scripts and system project plan.Developed, tested and administered new standard Crystal Reports for newly developed workflows. Maintained, updated and configured existing single and multi-record Crystal Reports. Rendered reports in different formats and automated report distribution. -
Sql DeveloperThe Bozzuto Group Jan 2013 - May 2014Greenbelt, Md, UsDeveloped and maintained financial reports for upper management on JD Edwards / Oracle database using SQL stored procedures and Crystal Reports. Administered MS SQL Server 2008. Performance Review system development and maintenance. -
Programmer Analyst / Database AdministratorSaic-Frederick, Cmrp/Rchspp Nov 2005 - Dec 2012General and specialized IT support to Regulatory Compliance and Human Subjects Protection Program (RCHSPP). Maintenance, development and administration of TrackWise process management system responsible for monitoring on-going clinical trials sponsored by NIAID and NCI. TrackWise is used by more than 250 users for monitoring protocol and regulation requirements and assisting Responsible Investigators in applying for new investigational drugs and therapies. Production and maintenance of over 140 standard and ad-hoc Crystal Reports for TrackWise system.Development and maintenance of professional web sites, Sharepoint sites and other applications supporting Clinical Monitoring Research Program (CMRP). Development and administration of new applications through user consultation, requirements analysis, and data flow analysis.
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Database / Webfocus DeveloperMori Associates, Pmrs/Navy Project Sep 2004 - Nov 2005Database and user support for Procurement Management Reporting System (PMRS) of US Navy. PMRS system is designed to capture all contracting and purchasing actions and dollars by US Navy contractors. Development, administration and maintenance of all PMRS reports using WebFOCUS reports on Oracle database. https://www.navypmrs.nor.fisc.navy.mil/
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Data Manager / Clinical ProgrammerThe Orkand Corporation, Nih - Nci/Uob Jul 2003 - Jul 2004Program and data management administration for ongoing clinical trials in Urology Branch at NIH/NCI. Collected, interpreted, abstracted, and reviewed data in MS Access and Oracle Clinical databases. Developed queries and reports based on client’s needs. Performed database administration tasks. Prepared and maintained research data for audits. Supervised 2 members of the team on the data entry/data abstraction tasks. Obtained research information from team members to insure data integrity. QA and QC of data entry for data managers.
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Project Support SpecialistStandard Technology Inc Sep 2001 - Feb 2003Actively participated in the Benefits Transformation Project to outsource Lockheed Martin benefits system to Mellon Bank. Created, updated, and maintained standard reports and reporting objects on Oracle database using WebFOCUS tool. Provided technical support and maintenance for client database users.
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Software EngineerConvera Corporation Jan 1999 - Jan 2001Worked in a team environment to develop, maintain and enhance award winning search engine platform – RetrievalWare. Developed HTML templates with embedded Macro Language and JavaScript functions to maintain the front end User Interface. Worked in a team environment to test and debug new versions of RetrievalWare. Revised and improved existing software code. Added and enhanced functionality in the graphical Intranet software. Analyzed Knowledge Contributor software to upload new libraries. Created SQL scripts for database generation. Wrote database triggers, stored procedures, stored functions and stored packages to support applications. Designed and developed reports for the applications using SQL, PL/SQL
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Software EngineerPharmark Corporation Jan 1998 - Jan 1999Designed and implemented full cycle C/C++ programs that analyzed, counted, and extracted medical records from a large medical database. Developed small C programs for statistician analysis. Enhanced and maintained support C programs for internal use. Implemented command procedures on VMS platform.
Andrey Chudny Skills
Andrey Chudny Education Details
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Hood CollegeManagement Of Information Technology -
University Of MarylandGeneral -
Trailhead By Salesforce -
Ces/Jds
Frequently Asked Questions about Andrey Chudny
What company does Andrey Chudny work for?
Andrey Chudny works for Novavax Inc
What is Andrey Chudny's role at the current company?
Andrey Chudny's current role is Senior Information Technology Engineer at NOVAVAX INC.
What is Andrey Chudny's email address?
Andrey Chudny's email address is st****@****hoo.com
What is Andrey Chudny's direct phone number?
Andrey Chudny's direct phone number is +120275*****
What schools did Andrey Chudny attend?
Andrey Chudny attended Hood College, University Of Maryland, Trailhead By Salesforce, Ces/jds.
What skills is Andrey Chudny known for?
Andrey Chudny has skills like Trackwise, Crystal Reports, Sharepoint Designer, Shared Services, Webfocus, Dreamweaver, Photoshop, Pl/sql, Asp.net, Vbscript, Javascript, C/c++.
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