I
have more than 11 years of IT experience across various platforms and
technologies. Out of these 11 years, I have worked for 6 years in Pharma Supply
Chain domain implementing various Pharma Serialization projects. This includes
implementation of Serialization System for California Pedigree Serialization
law and Federal DSCSA Serialization law. Currently I am working as IT
Consultant and Tech Lead for DSCSA Track and Trace Serialization Project.
Qualifications
DSCSA Serialization
GS1 EPCIS
Pharma Supply Chain
Barcodes and HDA Guidelines
Full SDLC for Serialization System for Pharma Manufacturers, Wholesale Distributors, Repackagers and Pharma 3PL Business.
Java/J2EE, EJB 2.1, EJB 3.0
SOAP (JAX WS) and REST (JAX RS) Web Services
EPCIS Event Management System (IRIS - Frequentz)
Integration with Packaging line Optel Vision Software
IBM WebSphere App Server
DB2
Relevant Experience
I have deep understanding of Pharma Supply Chain, Track and Trace and Serialization process as i am working in this area from the days of California State Pedigree law which was first of its kind in Pharma Serialization. Later it was pre empted by Federal Drug Supply Chain Security Act (DSCSA).
I lead a team of experts in Serialization and have worked closely with Client Enterprise Architects to design and develop solutions for Track and Trace - Serialization.
The system that my team has developed is successfully deployed and running in more than 22 pharma wholesale distribution centers across the United States.
The details of Pharma Serialization includes but not limited to understanding of EPCIS Event managemnt system, GS1 EPCIS Guidelines, integration with packaging lines, WMS, ERP, AS2, Handheld devices, Barcode formats, Barcode Readers. I have good understanding and experience of challenges that we face coordinating and integrating these systems.
Presently i am working as Serialization Consultant and Tech Lead for all Serialization related efforts related to DSCSA Serialization. All our projects have used Java/J2EE Technology stack.
Experience
Serialization Consultant and Tech Lead, 06/2016 to Current Infoblox Inc. – Washington, DC,
Project Description
Track and Trace – Serialization Pilot for Wholesale Distributotion with EPCIS 1.1
As per DSCSA (Drug Supply
Chain Security Act), by November 2017, all manufacturers should provide
electronic barcode depicting GTIN, Serial Number, Lot Number and Expiration
date on each sellable unit. They should also maintain the data in their
repository to verify “Returns” if any. For Repackagers, this has to be implemented
by November 2018. This project, which is in Design phase as of now, aims to
fulfill these requirements. We are building following components as part of
this poject:
A serial number
management service which will work as an interface between Event Management
System (IRIS) and Warehouse Management Systems as well as Packaging lines. This
service will be responsible for managing serial numbers pool, importing serial
numbers and returning unused serial numbers.
Aggregation
Service to build aggregation between Case and items.
Transformation
Service to transform EPC as part of repackaging service.
Serialization
Service to return item information related response to WMS
Enable
masterdata flow from ERP System to Event Management System.
Process
EPCIS Document coming from vendors.
Create
EPCIS Documents for outbound shipment.
Responsibilities:
Work with
Enterprise Architect to create Concept Analysis Document which represent
feasibility study and defines alternate concepts or options that satisfy
business needs.
Work with
Business Analysts during requirement gathering to help transform business
requirements into technical specifications.
Help in defining
technical landscape and get SAR approval.
Create Detailed
Design Document and get EA approval.
Lead the development
work (Coding and Unit Testing) and ensure high quality deliverable.
Support during QA
testing and User Acceptance Testing.
Coordinate with
various team for production deployment and support during service warranty
period.
Give necessary
build to run transition and handover the project to run team.
Serialization Consultant and Tech Lead, 03/2015 to 05/2016 Infoblox Inc. – Columbus, OH,
Project Description:
Track and Trace – Serialization Pilot for Wholesale
Distributotion with EPCIS 1.1
This project was addition
to the existing lot tracking functionality. The objective of the project was to
enable Serialization in wholesale distribution business of Cardinal Health at a
very small scale without compromising the productivity or speed of supply
chain. It also aimed to process lot level EPCIS document which was a new
specification from GS1. Below pointers summarizes the project:
Enable processing
of Lot Level and Serialized EPCIS Document.
Enable flow of
masterdata corresponding to Serialized Products.
Build
component to integrate with Handheld device picking applications.
Store picking
data and validate in returns process.
Return
Transaction Data from EPCIS to the WMS.
Responsibilities:
Work with Business
Analysts during requirement gathering to help transform business requirements
into technical specifications.
Create Detailed
Design Document and get EA approval.
Lead the
development work (Coding and Unit Testing) and ensure high quality deliverable.
Support during QA
testing and User Acceptance Testing.
Coordinate with
various team for production deployment and support during service warranty
period.
Give necessary
build to run transition and handover the project to run team.
Serialization Consultant and Tech Lead, 2014 to 02/2015 Smith Seckman Reid, Inc. – Denver, CO,
Project Description:
Track and Trace – Lot Tracking
The Drug Quality and
Security Act (DQSA), was signed into law on November 27, 2013. Title II of
DQSA, the Drug Supply Chain Security Act(DSCSA), outlines critical steps to
build an electronic, inter operable system to identify and trace certain
prescription drugs as they are distributed in the United States. DSCSA
establishes a two phased national system for tracing pharmaceautical products
through the supply chain and preempts existing state pedigree requirements.
Deadline for first phase of this project was Jan 1 2015. As per DSCSA
guideline, starting from Jan 1 2015, all the party in pharma supply chain
should receive, store and send transaction data either in electronic or paper
format. This project is intended to implement the requirement traced from Drug
Supply Chain Security Act for Cardinal Health.
Build and deploy
ASN Handler to process lot level ASN (Advanced Shipment Notice)
Build and deploy
system to extract Transaction Data (TD) from ASN. TD is the combination of TI,
TH and TS (Transaction Information, Transaction History and Transaction
Statement).
Build and deploy
web service and messaging interface for various business units of Cardinal
Health so that there WMS can get Transaction data either by calling web service
or by sending messages asynchronously.
Build and Deploy
to process transaction data by manual entry if upstream partner has sent paper
document instead of electronic ASN.
Responsibilities:
Work with
Business Analysts during requirement gathering to help transform business
requirements into technical specifications.
Negotiate
interface with different business units.
Create Detailed
Design Document and get EA approval.
Lead the
development work (Coding and Unit Testing) and ensure high quality
deliverable.
Support during QA
testing and User Acceptance Testing.
Coordinate with
various team for production deployment and support during service warranty
period.
Give necessary
build to run transition and handover the project to run team.
Serialization Consultant and Tech Lead, 07/2013 to 03/2014 Robert Bosch Tool Corporation – Sunnyvale, CA,
Project Description:
WSE - RFID Retirement
Cardinal
Health decided to phase off WSE (Websphere Sensor Events) product from
Serialization landscape. RFID has some practical limitations due to which
Cardinal Health decided to remove RFID readers and use only 2D Barcode readers.
Since WSE was mainly used for RFID readers it was obvious that we need to
retire WSE. Its retirement lead to several changes in the middle-ware. IRIS
upgrade was also part of this project. We deployed IRIS version 3.2 in this
project.
Responsibilities:
To assess the
amount of changes required because of WSE Retirement.
Design the system
in updated landscape.
Development of
new components related to Serialized ASN.
Assess the impact
of IRIS upgrade. Integration of new IRIS with existing system.
Development
related to changes in middleware.
Serialization Consultant and Tech Lead, 10/2009 to 06/2013 Robert Bosch Tool Corporation – Florence, KY,
Project Description:
Pedigree Serialization
The
Pedigree Serialization solution is responsible for pedigree life cycle and
serial number management at cardinal distribution centres as per California
state pedigree law. The functionality provided by the pedigree management
module includes receiving electronic pedigrees, authenticating pedigree, moving
the pedigree through different states, transmitting outbound pedigrees and
digitally certifying pedigrees. The functionality provided by the serial number
module includes updating the disposition of serialized items as they transition
through the re ceive, pick, pack and ship processes. We used inference modal to
read prescription drug RFID chips. RFID antennae were integrated to Websphere
Sensor Events (WSE). WSE reads the read coming from RFID chips and sends it to
its read handler where it gets processed and sensor event is formed. This
sensor event is then processed by our EJB component to build EPCIS event and
send it to Event Management System (IRIS).
This
project was deployed in production in three different phases. In the first
phase of this project electronic pedigree was kept out of scope and only ASN
processing was in scope. Second phase of this project included electronic
pedigree also. Third phase of this project was for SPD (Specialized Pharmacy
Division) Consginment which involved tracking of some costly drugs which needs
to be stored in low temperature all the time. SPD Consignment has nothing to do
with California Pedigree law but since we were using the same event managment
system we clubed the two project.
Responsibilities:
Gathering
requirements, detailed design, coding, unit testing, dev integration testing
and managing offshore team.
Senior Software Engineer, 06/2009 to 08/2009 Client: Cardinal Health, Employer: Wipro Ltd – City, STATE,
WSE RFID POC
The
objective of this project is to demonstrate the basic functionality of
Websphere Sensor Events and how it integrates with RFID system. The POC
demostrates one cycle of receiving, picking and tracking the prodcuts. This is
a J2EE web application which can take data from WebSphere Sensor Events and send
back the response after processing the same.
Responsibilities:
Coding
and Unit Testing
Senior Software Engineer, 10/2008 to 07/2009 Client: Cardinal Health, Employer: Wipro Ltd – City, STATE,
Project Description:
Pharma Brandsite
This
is a web application for mobile devices. This application is developed
specifically for Apple iPhone and Blackberry devices. The web application
basically contains two set of web pages. One set for iPhone and other set is
for blackberry. The iPhone user Interface has been used to make sure that the
look and feel of the web pages for iPhone is similar to the look and feel of
iPhone native applications. Similarly the blackberry pages are tuned for
blackberry mobile devices. The web application has been developed keeping in
mind the limitations of mobile phones.
Responsibilities:
Requirement
Gathering, UI Design, Coding and Unit Testing
Technology Consultant, 07/2007 to 06/2008 Client: Citibank, Employer: Hewlett Packard – City, STATE,
Project Description:
STEWARD – System for Tracking Everything With Advanced
RFID
STEWARD
stands for "System for Tracking Everything With Advanced RFID". This
is Java Web Application integrated with BEA Edge Server. This is an end to end
solution to commission and track the assets and media in Citibank Data Center.
Responsibilities:
Design, Coding and Unit
Testing
Software Engineer, 08/2006 to 02/2007 Hewlett Packard – City, STATE,
Project Description:
IPCS - Item Pricing and Configuration Service
IPCS
is a web service to give pricing information to business partners. This web
service was consumed by B2B applications.
Responsibilities:
Bug Fix and Enhancements
Software Engineer, 07/2005 to 07/2006 Hewlett Packard – City, STATE,
Project Description
EasyConfig
This
is a java web application primarily meant for config creations for desktop,
printers and notebooks. This application is used by knowledge engineers and it
consumes IPCS web service IPCS to get pricing information.
Responsibilities:
Bug Fix and Enhancements
Education
Master of Science: Computer Applications, Expected in 2005 Hamdard University - New Delhi, GPA:
Bachelor of Science: Physics, Expected in 2002 AMU - Aligarh, GPA:
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