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Serialization Business Analyst/Consultant - United States  

ESP (company)


Posted on : 10 June 2017

Project Description

The Serialization IT Business Analyst position is responsible for supporting the EPCIS Implementation and CMO/3PL Integration projects from the business analysis perspective.  The position requires business knowledge and system knowledge with an understanding of global regulations in the Serialization area and best-practices in supporting Serialization solution.

  • Gather and document user requirements and business processes 
  • Partner with business clients and delivery teams to determine appropriate solutions 
  • Work with IT Quality to conduct risk assessment against the user requirements 
  • Document and analyze the Information needs of the business and ensure appropriate solutions are delivered 
  • Perform impact analysis for application changes and business process optimizations 
  • Support User Acceptance Testing by working with the business and SQA (help define test scope, scenarios to be tested, identify areas of impact requiring regression testing, etc.) 
  • Assist in the development of detailed work practices/user documentation 
  • Assist in the development of data migration plan 
  • Manage the project implementation activities and ensure that the solution delivered meets the business requirements 
  • Work with Business Intelligence team on Reporting and Analytics 

Desired Experience:
  • Pharmaceutical/Supply Chain consulting experience 
  • Experience in implementing Serialization solutions 
  • Demonstrated strong Business Analysis skills 
  • Understanding of Pharmaceutical Validation processes 
  • Familiarity with packaging/distribution operations 
  • Familiarity with basic ERP Functions 
  • Working knowledge of SDLC software development and support methodologies 
  • Experience working with change controls and GxP validation protocols 
  • Strong written and oral communication skills 
  • Ability to work in a team-oriented, collaborative environment 
  • Ability to facilitate meetings and follow up with resulting action items. 
  • BA/BS required, MS preferred 

Expected Activities/ Deliverable
  • Develop URS documentation 
  • Develop business process diagrams 
  • Develop System Impact Assessment, Functional Specification, Data Migration Documents in collaboration with the vendor consultant. 
  • Review technical design documentation 
  • Develop or review Traceability Matrix document 
  • Interact with Vendor Professional Services resources 
  • Interact with Client IT leads 
  • Interact with Client Technical Architects 
  • Review Test Plans, Test Scripts and execute Test Scripts (system testing)