CV
Roi Kapah
Professional info
I'm 6+ years Experienced Developer. Proficient with developing, supporting & managing TrackWise EQMS for regulatory compliance (FDA 21 CFR Part 11) companies from Life Science industry.
Areas of expertise:
• TrackWise Developer / TrackWise JAVA Web Services Developer/ Crystal Developer with analytical skills, analyzing customer needs including deploying and managing global quality systems, conducting onsite meetings with global customers to discuss projects timelines, business requirements and assistance with go-live activities.
• Extensive installation, configuration, troubleshooting and maintenance knowledge in TrackWise EQMS, TrackWise Web Services, Microsoft environments & RDBMS (MS SQL Server / Oracle), SAP Crystal Reports development.
• Highly experienced with quality processes such as: Deviations, CAPA, OOS, Change Control, Customer Complaints, Events Management, Audits etc.
• Providing TrackWise technical / business support services to customers in US/Europe.
• Experienced with CSV (Computer system validation) including gap and impact analysis, risk assessments etc.
• Technically oriented with complicated & regulated production / non production environments.
Work experience
trackwise Integration Consultant & web services developer
at Sparta Systems
2012- 2014
Analyze business and functional requirements of our customers , develope web services with java,eclipse,axis2.
Work with customers to evaluate and develop logical work flows, representative of business processes, which will be configured in TrackWise.
Design and configure customer requirement into the software.
At the customer site: Install TrackWise® (using automated installation scripts) related to customers’ tracking needs (as detailed above), and configure TrackWise accordingly.
Train TrackWise® administrator users in the overall TrackWise® configuration and reporting tools (so that once the initial configuration is complete, these users can implement configuration changes as their needs continue to evolve).
Train end-users, on their configured TrackWise® tracking application(s).
Assist with Computer Systems Validation (CSV) and related documentation.
Implement TrackWise® in conjunction with 21 CFR Part 11 (Electronic Records and Electronic Signatures), Current Good Manufacturing Practices (cGMP), and related FDA regulations.
Senior Java Developer
at ECI Telecom
2006 - 2011
Leading java developing team, running a small team.
Instructing developing teams in Israel, U.S. and India.
Involved in projects development from requirements, design implementation and training, writing related documents.
Running a Java course for ECI employees.
Graph algorithms.
Java Developer
at blue phoenix solutions
2004 - 2006
Developing J2EE core banking project, writing JSP's.
Being part of international development team.
Creating and performing Unit tests.
Developing and testing Appbuilder applications
Languages
Java
Skills
Axis2
My SQL
Oracle
Design Patterns
Integration
Web Services
XML
CSV
JSON
Quartz
JEE
Tomcat
C#
Education
Bar Ilan University - Israel.
2001 - 2004
Bachelor of Compurter Science (BSc), Grade of 85.