Chandhoke
Chandhoke
Business Analyst
Chandhoke chan092711@[Link] (267) 299-8328
Summary:
Over 8+ years of professional experience as a Business Analyst in the Healthcare, Pharmaceutical, Biotech and
Medical Device industries.
Extensive knowledge of SDLC with different methodologies, such as SDLC, Waterfall, Scrum, RUP, Extreme
Programming and Scrum-Waterfall Hybrid.
Proficient in authoring Business Requirement Document (BRD) and deriving Functional Requirement Document
(FRD).
Instrumental in clarifying business requirements, experienced in performing Gap Analysis, Impact Analysis,
Risk Analysis, Traceability Matrices, SWOT Analysis, and Cost Benefit Analysis.
Highly experienced in using Blueprint as a tool for documenting business requirements, creating diagrams,
making versions of FRD, etc.
Hands-on in Data Analysis, System Analysis, Data warehousing, Data Migrations, Data Processing and ERP
applications.
5years of experience in working with Tableau Desktop, Tableau Server, and Tableau Reader in various versions
of Tableau 9.x/8.x/7. x.
Web portal/site development, UI/customer experience, content development, testing.
Rich Experience in managing entire data analysis project life cycle and involved in all phases, including data
extraction, data cleaning, data visualization and data analysis with large datasets of structured and unstructured
data.
Participation in 21 CFR Part 11 and GxP compliance assessments.
Extensive experience in preparing and executing qualification protocols (IQ, OQ, PQ).
Proficient in dealing with Standard Operating Procedures (SOPs), Test plan, Laboratory information
management system (LIMS).
Participation in 21 CFR Part 11 compliance assessments.
Implementation of 21 CFR Part 11 regulations.
Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current
pharmaceutical industry standards.
Design and deployment of MES system to replace paper based or manual systems including weigh & dispense
and material tracking in a pharmaceutical environment.
Worked on data profiling and analyze data in the database SQL server by running SQL queries. Expertise in
running SQL quires on oracle databases, Microsoft server etc, for the purpose of data analyst.
Dealt with simple complex SQL queries to extract data from database for the purpose of data analysis and testing
and extensively used DDL and DML Commands in SQL.
Structured workflow for entire content lifecycle from early research and development (R& D) through
eSubmission.
Expertise in Manufacturing domain ERP's; IFS Applications 7.5, 2003 & SAP on modules Order Management,
Invoice Management, HR Management, Project Management, Supply Chain Management, Document
Management, Report Management (Crystal Reports and Quick Reports) and Security/Roles Management.
Implementation, Service, Support & Maintenance with various domains with through Knowledge on IFS, SAP.
Hands on Expertise in Document Management in Enterprise level (ERP: IFS) using SharePoint.
Manage key department business intelligence applications and data warehouse acting as the technical liaison for
data warehouse / business intelligence issue.
Spearheaded the business process and technology implementation of the first-ever centralized global payment
data analytics and reporting process.
Interface with other relevant WFB groups: Enterprise Transition Services, Internet Services group, Online
Customer Services, etc.
Experience working with web applications and supporting a corporate website for a marketing perspective.
Accomplishments in analysis of large-scale business systems, Project Charters, Business Requirement
Documents, Business Overview Documents, Authoring Narrative Use Cases, Functional Specifications, and
Technical Specifications, data warehousing, reporting and testing plans.
Experience with Project Management, in the areas of Project Planning including Project estimations (cost, dates,
resources) using MS Project (MPP).
Extensive experience in creating/executing Test Plans, Test Scenarios and Test Cases and assist in User
Acceptance Testing (UAT).
Worked extensively with Marketing & SFDC data modeling using Lead, Contact, Opportunity, and Account
objects.
In depth understanding of the AS-IS and TO-BE business processes and experience in converting these
requirements into technical specifications for preparing test plans.
Involved in Designing and review of various documents including the SRS, FRD, SRS, Use Case Specifications,
data requirements, RTM, GUI Requirements, SLA's, RFP and project initiation document.
Sound in Suggesting system automation solutions to business problems or opportunities; providing automated
solutions that are cost effective and that meet user requirements.
Supporting developers with unit testing and troubleshoot where the issues emerging.
Experienced in creating tableau dashboards, worked with different types of data visualization charts in tableau.
Expertise in GUI testing, Functionality testing, System testing, Unit testing, Integration testing, Front end testing,
Back-end testing and Regression testing of Client/Server and Web based applications
Demonstrated capability in managing people, leading teams on various complex projects.
Extensive experience on Excel, Word, PowerPoint, MS Project, MS Visio, Rational Suite and SQL.
Experienced in writing System Use Case Specifications, Object Oriented Analysis and Design, Change
management, Risk Management, Workflows and Unified Modelling Language (UML) diagrams, Web Portal
Content Management.
Worked as a member of User Acceptance Testing (UAT) Team.
Strong Communication and Presentation Skills substantiated in past assignments with developers, project
managers, subject-matter experts, stakeholders, system implementers, and application end-users.
Work Experience
Sr. Business Analyst
Zynerba Pharmaceuticals- Devon, PA July 2020 - Present
As a BA, led project teams to ensure the requirements are fulfilled successfully. Extensively involved in the
implementation of the systems via tools like Content Manager, Structured Data Manager, and Control Point, business
analysis, maintenance of all CSV (Computer Systems Validation), User Acceptance Testing (UAT) of COTS software,
and implementation of SQL queries.
Responsibilities:
Documented business requirements and communicated these requirements to the development team for the
design and implementation of business solutions.
Involved in Developing and supported dynamic documents for EHR system integration (Eclipsys).
Provided support to all facilities, via phone or in person, pre, during, and post EHR (Eclipsys) implementation
while maintaining communication with site manager, including hardware validation (printers and workstations)
at sites integrated with EHR.
Worked on Module testing and Factory acceptance testing for Abbott using Werum-PASX Manufacturing
execution Systems software.
The pharmacy system RxConnect is built specifically to support this defined operational process and all 7400
Abbott Pharma pharmacies have the same defined behavior for receiving and preparing a prescription for a
patient.
Writing of OQ scripts for modules-Assay Design, Plan Analytical Runs, Study Design, Study Configuration, Bi-
Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in Watson LIMS.
Communicated with customers using web-based tools and demonstrates the associated proficiency in typing and
grammar. Guided customers with financial decisions to protect/collect and adjusts customer accounts.
Responded, supported, and provided resolution of EHR production issues including 3rd party vendor follows up.
As well as any ancillary system issues for the end users.
Involved in Developing test scripts for integrated testing in new facilities that were implementing EHR.
Participated on several projects including KBMA (Knowledge Base Medication Administration) and VDI
(Virtual Device Interface) as part of the new initiatives to enhance the EHR system.
Experience working with JD Edwards and other MES interfaces.
Coordinate and manage specs development with internal IT Rhapsody developers for the data exchange between
the clients EHR Systems.
Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with
FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
Built, tested, and implemented an HL7 ADT, ORM, ORU, DFT, and MDM system using the Rhapsody Interface
Engine 5.4.
Worked on the financial area of ERP system, concentration with Supply Chain Management, GL, AP,
Manufacturing SSB Project, Purchase and Invoicing.
Worked with all aspects of Epicor ERP system. This includes sales, purchase orders, accounts payables, accounts
receivable, MRP, quality control, shipping and receiving.
Project status reporting, user / web customer communication, manage expectations.
Manage multiple clients' EHR interface project development.
Adept in sales analysis, marketing & customer support business processes used by [Link] customers and
recommendations to customers for improving their processes using [Link].
Analyzing the Prescriptive authority system / business requirements which prepared for RxConnect.
Review of and modifications to HTML and customer-facing web content.
Provided support to BIS department from a clinical knowledge point of view when necessary during integration
projects.
Provided Production support to Tableau users and Wrote Custom SQL to support business requirements.
Coordinated with Business Owner, Application Vendor, Business Project Teams, Payers, and Clearinghouses to
bring all processes to a level of execution to mitigate any impact to current revenue flow under the 5010-
compliancy requirements.
Developed, analyzed and reviewed test scripts to check the functionalities of the application for 21CFR part 11
compliance.
Worked with SAP functional team to validate the transactions and modules to be complaint with 21 CFR Part 11
and GMP regulations.
Have done analysis on HL7 that establishes criteria for representing and communicating data associated with
health care.
Enhance fraud security measures for online customer support systems.
Extensively worked with EDI transaction 837 (Professional & Institutional) following the HIPAA compliance
EDI standard format of x12.
Used UML during requirements gathering and Involved in Creating Use Case Models and Use Case Diagrams
for the purpose of stakeholders in the project to help them understand the workflow of the system associated with
the requirements.
Implement MES solutions and integration with ERP and or/control equipment.
Created different graphs and charts such as Pie Chart, Bar Chart, etc. using Ms Excel and also created reporting
presentation using Ms PowerPoint.
Conduct business process analysis and design for the sales and marketing business areas leading design
discussions with senior management.
Worked on Data cleansing and loading application using ETL, Tableau and SQL Server.
Involved in Developing Functional Specification document for each sprint including Interaction diagrams, and
User stories.
Administered SharePoint, and Smartsheet for permissions, access, business documentations, and status updates
as part of team management.
Facilitated RIS (radiology), Soft Med (laboratory) and Allscripts (Eclipsys) EHR integration projects.
Worked on X12 format under HIPAA guidelines. Analyze EDI -X12 data elements captured by the existing
reporting to validate it against the data elements required for new reporting.
Worked closely with office of health care reform on current issue from CMS on 834 files. Raised tickets with
CMS and triage the issues on basis of severity.
Involved in Creating DMR mapping spreadsheets, Source to Target mapping documents including the
transformation rules.
Performed Manual Testing like Positive and Negative Testing
Worked with the Business and the ETL developers in the analysis and resolution of data related problem tickets
and other defects.
Wrote a business case in PowerPoint to explain the need for SharePoint to centralize reporting, SharePoint Team.
Involved in Developing BSDs for business services related to eligibility verification, and enrollment.
Business Analyst
Abbott Pharma - Elk Grove Village, IL June 2018 – June 2020
This project-involved implementation of a new interactive Healthcare Communication System, which automated the
manual workflow, processes followed by physicians and medical staff to suffice patient needs. The process also involved
integration of EHR system.
Responsibilities:
Responsible for multiple projects under Records Information Management team.
Managing and supporting the implementation and maintenance of quality systems MF Control Point and Content
Manager.
Driving all aspects of the ERP systems archival project for Finance and Quality department. JDE and other
peripheral systems are part of the project.
Involved in Implementing, supported, and trained end-users on COTS software.
Authored IQ’s for installation Watson LIMS.
Reviewed IQ/OQ/PQ’s
Authored OQ and PQ test scripts to challenge all regulatory and security requirements.
Involved in integrating with Manufacturing execution system (MES) and electronic batch record(EBR).
Leading document separation project between Baxalta and Shire Physical and Electronic records.
Conducted impact assessment and risk mitigation through detailed business analysis.
Responsible for leading development & testing teams and acted as SME for Rx claims data.
Lead and coordinate marketing campaign and reporting processes and associated tasks such as requirements,
functional specification and other client documentation.
Responsible for maintenance and delivery of all CSV (Computer Systems Validation) documentation including
Test Scripts, System and Test Deviation Reports, Traceability Matrix, Test Protocols, and Summary Reports.
Involved in Creating and maintained validation documents like User/Functional Requirement Specifications,
Design/Configuration Specification Documents, Security Requirements Document, Technical Design
Specifications Document, and Operational SOPs.
Aided management in standardizing web applications by preparing GUI standards and recommending
alternatives for incorporation in a phased, iterative manner.
Import Wachovia customer databases into XA online Customer Authentication SOR database.
Performed PL/SQL queries to confirm the data records from the database.
Worked on performing GAP analysis of business requirements to vendor requirements. Assessed vendor
documentation.
Facilitated JAD sessions with SMEs and business analysts from other feeder systems for a detailed analysis and a
better understanding of impact of various projects on each other.
Worked on creating functional requirement documents for the impacting projects
Integrated and tested both SAP(ERP) and MES systems.
Worked on UAT plans with several test cases for each project to ensure that the system runs smoothly after the
proposed enhancements or changes have been made.
Extensive knowledge in all aspects of operational functions from marketing, pipeline management and
forecasting to customer acquisition, fulfillment, and support. Flexible and open to change, pursues self-
development, maintains lasting relationships, and thrives on challenges.
Worked on Documentum for Version Controlling, to maintain up to date changes in the documents.
Worked on managing changes to requirements through change control -clear case, MQC, document.
Involved with the team working on complete 21 CFR Part 11 compliance assessments of laboratory and
manufacturing systems.
Created PowerPoint presentations, graphs and charts for management reporting.
Worked with the team validating computerized laboratory equipment like Atomic Emission Spectroscopy
(automated in process equipment) based on GAMP 4.
Involved in the implementation of Document Management System meeting requirement deadlines.
Proposed solutions to reporting needs and develop prototypes using SQL and Business Objects that address these
needs.
Responsible for business requirements gathering and technical requirements analysis and documentation for File
Net-based document management system.
Business Analyst
UPM Pharmaceuticals - Baltimore, MD Dec 2016 –
May 2018
UPM Pharmaceuticals is a Bristol, Tennessee-based independent contract development and manufacturing organization
(CDMO) serving the pharmaceutical and biotechnology industries. UPM provides high quality pharmaceutical drug
development services that include formulation development, cGMP manufacturing and packaging, analytical method
development and testing from concept through commercialization. The system majorly maintained a record of all the
accounts and respective contacts and opportunity details of the UPMS clients.
Responsibilities:
Management of Wholesaler/Distributor Chargeback Payments through the Caris / Core / Model N system
Demonstrate detailed understanding of the department and a broad knowledge of other areas of the business.
Reconcile incoming Chargebacks submissions based on frequency of distributor submission schedule (Daily,
Weekly, Monthly) and process resubmissions.
Research, troubleshoot and solve problems of broad complexity Communicate with Channel Partners, Operating
Companies, Distributors, and other areas within CSM via e-mail, conference calls, and visits to address and
eliminate various drivers of errored lines.
Assist Department members in communications with Distributors and eliminate various drivers to errored lines.
Worked on researching and pre-grooming user stories by understanding the business requirements as stated in
the business requirements matrix by including key members from business teams, underwriting team, and
closing SMEs and later translating those in an IT standpoint to explain the work to the team.
Timely reconciliation Model N and research unidentified deductions taken by Distributors to deter.
Executed Test Cases in System, Integration, Backend, Front-end, Regression, E2E, and UAT using SQL queries
and UI testing on applications.
Worked with UAT testing team to setup data, share test cases, and provided results walkthroughs.
Well versed in Business Process Modeling with expertise in creating User Cases, Sequence Diagrams, Class
Diagrams, Activity Diagrams, writing User Stories.
Provide leadership to other team members and transfer knowledge across departments, operating.
Worked on Prioritizing requests for new data and Data Warehouse modifications with the Data Architects and
Data Warehouse Steering Committee.
Involved in the development of data mining requests best practices database to track data requests, data sources
and data extraction processes.
Worked on performing dry run and peer run of the authored test scripts to detect deviations and fix the bugs as
part of quality review.
Prepared PowerPoint presentations and managed sales databases.
Worked on writing Requirement Traceability Matrix, SOP's, Work Instruction, Risk Assessment.
Worked on documenting user-friendly compliance reports for installation qualification, operating qualification
and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards.
Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR, part
11.
Worked on acquiring all the lab data electronically at its source and a full complement of instrument interfaces.
Performed user acceptance testing to the check the various functionalities of LIMS.
Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS.
Business Analyst
Ranbaxy Pharmaceuticals - Princeton, NJ Sep 2014 –
Nov 2016
Ranbaxy is a Global Research driven Pharmaceutical Company dedicated to putting patients first. The company
discovers, manufactures and market vaccines and medicines in over twenty therapeutic categories. The striving efforts of
Ranbaxy is to provide society with superior products and services by conducting innovative research that improves the
quality of life and satisfy customer needs. The objective of the project was to create a Data Mart for Senior Management.
This Data Mart allows the Management to view Pattern and Sequence in the region with various perspectives of Business
and Research.
Responsibilities:
Generated Questionnaires for in Person Interview, Meeting, and JAD Sessions.
Involved in Creating BRD (Business Requirement Document) and got Sign Off from the Users.
Involved in Analyzing and documented Business requirements using Requisite Pro and detail design for full
understanding of the business.
Involved in Analyzing, Documented and managed all Project Requirements with RUP Methodologies
Used MS Visio to create Business Flow Diagrams and Workflow Diagrams
Maintained Requirement Traceability Matrix (RTM) and managed requirements.
Wrote SQL Statements to extract Data from Tables.
Involved in Creating Use Cases and did intensive Use Case Analysis
Involved in Developing User Acceptance Test Cases and completed User Acceptance Testing.
Used Test Director Tool for implementing Test Scripts and Tracking Defects
Used MS Share Point for sharing documents, calendars and other artifacts between users in different locations.
Worked on conducting detailed and comprehensive Business Analysis by working with end users and other stake
holders to identify the system, operational requirements, and proposed enhancements.
Worked on conducting multiple surveys & JAD sessions to understand the functionality in detail.
Worked closely with Health care professionals to understand their need.
Involved with the team providing process manual trainings to the end users of Health care professional portal &
Patient portal.
Worked with the team designing UI screen and layout for Patient portal by using MS- Visio.
Analyzed and discussed the business and functional requirements for the application under construction with
new fields, enhancements and modifications made.
Worked on creating Test Scenarios, Test Cases and Test Scripts for test execution as described in BRD (Business
Requirements Document) and FRD (Functional Requirements Document).
Worked on facilitating Joint Application Development (JAD) sessions with all IT group members for
communicating & managing expectations and to discuss various means for integrations with current system
using an adoption through execution strategy.
Conducted Gap Analysis on the AS-IS and TO-BE business processes and technology; and identified potential
pitfalls, risks, and issues.
Involved in the WebEx demos of wire frames and screen mock-ups for offshore development team and explained
business logic and functionality in greater detail.
Business Analyst
Baxter Healthcare, Round Lake, IL Aug 2013 – Aug
2014
The System is called Team Center Enterprise which is a BPLM (Baxter Product Life Cycle Management) System
centrally manages and Supports the Change Control Process used to Manage Large Amount of Product Data and
Documentation. I focused on working on the Change Management module and focused on customizing it according to
Baxter functionality. My job involved extensive research of the existing processes and mapping out new ones in order to
make this Change Management automation initiative efficient.
Responsibilities:
Fully responsible for requirements gathering and documentation.
Involved in Organizing and conducted extensive JAD sessions with users to identify, understand and document
requirements.
Involved in Validating the System in Accordance with 21CFR Part 11.
Involved in Creating use case narratives to record Subscription business rules.
Involved in Implementing SDLC which included requirements specifications, design, analysis and testing.
Wrote Use Cases, prepared use case diagrams (using Rational Rose) and followed Rational Unified Process at
every stage of the process.
Used Agile and Rational methodology in the project development for Rational Test Suite for various phases of
RUP.
Provided technical Expertise on the use of Rational Clear Case, Rational clear quest and Requisite pro, which
were used for Data archiving and Requirements Management.
Involved in preparing test plan and test cases based on functional requirements using Rational Test Manager.
Dealt with data mapping issues between various source systems and staging area and data-marts.
Produced functional specifications and led weekly meetings with developers and business units to discuss
outstanding technical issues and deadlines that had to be met.
Assisted the Senior Business Analyst in writing Functional Requirement Specifications (FRS) and User
Requirement Specification (URS).
Involved in Developing test plans and test cases according to business requirements.
Maintained Test Matrix with the test results obtained.
Identified Actors, Activities, Artifacts and Workflows and developed use case diagram using Rational Rose.
Participated in Automated regression and Non-Functional test plans
Met with client groups to determine requirements and goals. Utilized Rational Unified Process (RUP) to
configure and develop process, standards, and procedures and create a Business requirement Document.
Responsible for preparing Software Requirement Specification (SRS) and documenting them.
Involved in Creating Process Workflows, Functional Specifications documents and documented system
requirements.
Provide implementation assessment, strategy, and mentoring services for Rational Rose, UML and RUP.
Interacted with various cross-functional teams on building business use cases and understanding expenses and
revenue stream.
Working with clients to better understand their needs and present solutions using structured SDLC approach.
Interaction with the developers to report and correct bugs.
Involved in developing the systems implementation project management plan with milestones and steps from
procurement of vendors to project implementation and maintenance.
Followed a structured approach to organize requirements into logical groupings of essential business processes,
business rules, and information needs. Ensured that critical requirements are not missed.