Summary
Overview
Work History
Education
Skills
Timeline
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Vaishnavi Chelikam

Serialization SME | Tracelink | Axway | SAP Functional Consultant
Fremont,CA

Summary

Experienced Techno Functional Solution Architect with over 8 years in IT Operations and Project Management, specializing in end-to-end implementation, maintenance, migrations, upgrades, and integrations of Life Sciences applications like Axway, Tracelink, and SAP ATTP. Proven ability to collaborate with vendors, manage system lifecycles, and troubleshoot complex technical issues. Skilled in managing distributed environments, data handling, and personnel support. Strong credentials include:

  • Collaborating with vendors for component replacements and advanced problem resolution.
  • Maintaining and managing SAP ATTP and Axway systems, ensuring accuracy and efficiency in records.
  • Developing and testing SharePoint tools for daily ticket logging and monitoring.
  • Creating and maintaining master data in EPCIS and SNM for GTIN, GLN, MAH in Axway and SAP ATTP.
  • Supporting system data exchange processes and troubleshooting various issues, including LMS failed transactions.
  • Conducting User Acceptance Testing and performance testing for application upgrades, with knowledge of regulatory requirements like DSCSA and GS1 standards.
  • Configuring system infrastructures, performing ERP integrations, and managing B2Bi integrations.
  • Providing subject matter expertise in Serialization compliance, including FDA laws, FMD, and other global regulatory requirements.
  • Demonstrating strong organizational skills in managing multiple tasks and adapting quickly to changes.

Overview

5
5
years of professional experience
5
5
years of post-secondary education

Work History

SAP ATTP Functional Consultant

2 2020 - 9 2023

Client: Gilead Sciences

Project Type: Sustainment and Support

  • Collaborated with vendors to locate replacement components and resolve advanced problems.
  • Maintained SAP ATTP and Axway records with accuracy and efficiency.
  • Managing SAP ATTP system for the entire life cycle of serialization.
  • Monitor daily transactions in ATTP using Error Handling and Web Service monitor
  • Maintained servers and systems to keep networks fully operational during peak periods.
  • Maintained record of daily individual activities, behaviors and pertinent incidents for error analysis and assessment.
  • Helped streamline repair processes and update procedures for support action consistency.
  • Developed and tested SharePoint tools for Daily ticket logging and monitoring.
  • Created Master data in EPCIS and SNM for GTIN, GLN, MAH etc., in Axway and SAP ATTP.
  • Support and development of various processes related to system data exchange.
  • Troubleshooting LMS failed transactions.
  • Involved in diagnose and troubleshoot software problems and help our customers to install applications.
  • Troubleshooting different types of issues and testing complicated user cases.
  • Supports and maintains user account information including rights, security, and system groups.
  • Creating Problem Record, Change Request, Design Specification, Configuration Specification and few GxP documents.
  • Organized system infrastructure documentation and operating procedures, strengthening controls and enhancing overall performance.
  • Routing documents in Gvault (Veeva Vault)
  • Created PR and CR in Gvault (Veeva Vault) and Gtrack.
  • Involved in gathering business requirements for VRS from Adents and Chronicle.
  • Performed User Acceptance Testing and performance testing for application upgrade.
  • Includes testing with test cases created and tracked HP-ALM/Quality Center tool.
  • Knowledge of DSCSA regulatory requirements.
  • Knowledge of common GS1 standards used for Track & Trace.
  • Strong organizational skills - ability to manage multiple competing tasks and adapt quickly to changes.
  • Worked on System Configuration that includes service configuration, ERP integration and B2Bi Integration.
  • Knowledge of GS1 standards for identification, capture and sharing of data.

Away Support Lead

08.2018 - 02.2020

Client: Gilead Sciences

Project Type: Implementation and Support


  • Managing Axway Track & Trace system and SAP ATTP system for the entire life cycle of serialization.
  • Developed and tested SharePoint tools for Daily ticket logging and monitoring.
  • Developed SharePoint tool to do project estimations and assessments.
  • Created and developed multiple queries in Axway EPCIS module.
  • Created Master data in EPCIS and SNM for GTIN, GLN, MAH etc., in Axway and SAP ATTP.
  • Support and development of various processes related to system data exchange.
  • Support and Maintenance of Axway system (4.0, 4.1 and 1.3, 1.4 EU).
  • Monitoring transactions from Systech and Antares to Axway via Middleware.
  • Troubleshooting LMS failed transactions.
  • Troubleshooting Axway to middleware transactions.
  • Involved in diagnose and troubleshoot software problems and help our customers to install applications.
  • Troubleshooting different types of issues and testing complicated user cases.
  • Supports and maintains user account information including rights, security, and system groups.
  • Creating Problem Record, Change Request, Design Specification, Configuration Specification and few GxP documents.
  • Organized system infrastructure documentation and operating procedures, strengthening controls and enhancing overall performance.
  • Routing documents in Gvault (Veeva Vault)
  • Created PR and CR in Gvault (Veeva Vault) and Gtrack.
  • Involved in gathering business requirements for VRS from Adents and Chronicle.
  • Performed User Acceptance Testing and performance testing for application upgrade.
  • Performed functional and Integration testing of Axway application.
  • Includes testing with test cases created and tracked HP-ALM/Quality Center tool.
  • Knowledge of DSCSA regulatory requirements.
  • Knowledge of common GS1 standards used for Track & Trace.
  • Strong organizational skills - ability to manage multiple competing tasks and adapt quickly to changes.
  • Worked on System Configuration that includes service configuration, ERP integration and B2Bi Integration.
  • Knowledge of GS1 standards for identification, capture and sharing of data.

Technical Consultant

3 2017 - 8 2018

Client: Tracelink

Project Type: Implementation


  • Present and collaborate in client kickoff meeting discussions and use case reviews.
  • Configured customer environments using TraceLink best practices.
  • Design and document business processes to identify appropriate TraceLink configuration, integration points and event triggers.
  • Document and produce client specific requirements for business use case.
  • Write technical design documents where required.
  • Configure client system per specification.
  • Provide subject matter expertise on TraceLink's data interfaces.
  • Subject matter professional on Serialization for compliance with global regulatory requirements including USA FDA Law (DSCSA - Drug Supply Chain and Security Act), South Korea, China, Brazil, EU (FMD - Falsified Medicines Directive) and other markets serialization requirements.
  • Acquired expertise on SNM, SNX, SOM, MDX, EU Compliance, PT US modules, and knowledge of China and SK compliance modules.
  • Worked on Jira tool to create and track new project/issue.
  • Worked projects for different types/sizes organizations in Pharma landscape: global pharmaceutical companies, virtual manufacturers, CMOs, dispensers.
  • Knowledge on US, European compliance rules, China and India compliance.
  • Knowledge of DSCSA regulatory requirements, GS1 standards and EPCIS message transactions.
  • Conduct and advice customers on business review cases.
  • Support and development of various processes related to system data exchange.
  • Support business activities associated to Track and Trace process for both upstream and downstream partners.
  • Gain understanding of user and systems requirements and high level understanding of process and system design.
  • Create test plans and test cases to complete Performance Qualification of updates to TraceLink system.
  • Prepare for implementation of Serialization for Track and Trace compliance by supporting and assist to drive process changes to ensure execution of Serialization deadlines.
  • Strong sense of urgency, including ability to meet or exceed deadlines and set priorities.
  • Review, create, edit and test customer interfaces in various formats (CSV, XML, IDOC, EDI etc.).
  • Support user testing activities such as troubleshooting, reading error messages and ensuring expected results are delivered.
  • Provided subject matter expertise for systematic best-practices, overall product utilization and how global government regulations impact TraceLink configurations.
  • Log bugs and product enhancements into TraceLink tracking systems.
  • Provide deliverable status updates to Implementation Project Manager in timely, consistent and professional manner.
  • Contribute to Professional Services best practices.
  • Conduct issue investigation and collaborate with development on bug reporting and resolution.
  • Train new client on product features pertinent to use case.
  • Configure client system per specification.
  • Collaborate with leadership on training and documentation standards.

Associate

10.2016 - 3 2017
  • Training at Trizetto HQ, Denver on Healthcare overview, Facets Product foundations, Facets Technical foundations and Facets System Integration.
  • Good knowledge on Foundations of US Health Care, how it works, how government programs like Medicare and Medicaid works and what are their eligibility.
  • Worked on Facets Product Foundations by creating Subscriber/member, Provider, NetworX, Claims Processing and Utilization Management.
  • Processed claims which are in pending status and as well as completed status.
  • Good Knowledge on Facets data model in various modules likes Subscriber/Member, Claims, and Provider.
  • Worked with Facets Data Model Guides that provides complete set of Facets ER win diagrams.
  • This diagrams offers high level, logical view of data in Facets database.
  • Gained Knowledge on how to access data stored in Facets Database directly through Stored Procedures and Triggers.
  • Worked efficiently and effectively with EDI Administration to implement maps.
  • Knowledge on potential customization and considerations of Facets Custom Batch jobs and discovered locations and methods to troubleshoot custom batch jobs.
  • Knowledge on how to start new Custom Batch job solution, reviewing components of custom batch job to identify potential customization.
  • Explored how VB script uses Facets only security for Database Connection, modifying the VB script to add a custom parameter, adding code to the C# script to execute the stored procedure, and converting the result to XML.
  • Created a new XCOM Extension project in Visual studio by using the correct Naming Conventions, setting appropriate project properties and adding a required reference to the project.
  • Discovered steps to register an XCOM Extension in Facets and calling a method from extension data object to extract Facets data for your XCOM Extension, building and debugging XCOM Extension.
  • Created the Macros and defining existing events to register new extension in Facets.
  • Gained knowledge on features of Embedded Extensions and components of Facets Embedded Extension technology.
  • Created a new Embedded Extension project in Visual Studio by using the correct naming conventions, setting appropriate project properties, and adding a required reference to the project.
  • Explored the features of Facets Base Control including the purpose, available events, and available methods.
  • Creating a custom user interface using the Inherited User Control, calling a method from Facets base control to extract Facets data, building and debugging my embedded extension.
  • Knowledge on how Facets Integrated Service Library provides Web Services that expose Facets business logic.

Associate

04.2015 - 09.2015
  • Created new databases, involving importing and exporting: installing and configured database software for Oracle Application development environment.
  • Responsible for Oracle 9i logical and physical databases design, implementation, and maintenance.
  • Reorganized databases and sized database objects to meet standards and improve performance 30%.
  • Conducted SQL Server production database analysis on regular basis.
  • Performed troubleshooting for LAN problems for individual client basic software.
  • Provided customer assistance and support pertaining to database system queries and complaints.
  • Installed administered and updated Oracle database tools and systems.

Education

Master of Science - Computer Science

San Jose, CA
09.2015 - 08.2016

Bachelor of Science - Computer Science

Sathyabama University
Chennai
07.2010 - 04.2014

Skills

    Tracelink

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Timeline

Away Support Lead

08.2018 - 02.2020

Associate

10.2016 - 3 2017

Master of Science - Computer Science

09.2015 - 08.2016

Associate

04.2015 - 09.2015

Bachelor of Science - Computer Science

Sathyabama University
07.2010 - 04.2014

SAP ATTP Functional Consultant

2 2020 - 9 2023

Technical Consultant

3 2017 - 8 2018
Vaishnavi ChelikamSerialization SME | Tracelink | Axway | SAP Functional Consultant