Validation Lead/ Business Analyst

Professional Summary

Over ** years of hands-on experience in the life Sciences industries consisting of companies in the fields of Pharmaceutical, Health Imaging, Medical Devices & Bio Technological industries as a Validation/Qualification Engineer and Business Analyst. Extensively used automated tools for functional and Regression Testing.

Specific experiences include:

Analyzed functional Requirement Specifications and System Design Specifications

Developed and Reviewed Validation Plans, Qualification Plans, Validation Procedures and Validation Reports, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Created Validation Scripts from the Business Requirements and from the Use Cases by analyzing and identifying Scenarios from the existing Unified Modelling Language designs (UML’s)

Involved in EDI Validation with Inbound and Outbound data exchanged between different systems.

Used SAP as part of the Interface Validation for Processing Customer and billing information.

Involved in Authoring and Reviewing all the Computer System Validation deliverables, FDS, QAP, Validation Plan, Validation Summary Report and Traceability Matrix.

Hands - on experience in implementation of various IT processes on ServiceNow such as Incident and Problem Management, Change Management, HR Catalog, Service Catalog and other ServiceNow modules.

Extensive experience in Security, System Validation, Clinical Validation, functional Validation, integration testing, regression testing, User Acceptance testing, black box testing, GUI testing, back-end testing, browser compatibility testing, IVRS testing, debug software, and load/performance testing on Windows and Unix environments.

Validated the product as per the quality system Regulations for Medical devices (Current good manufacturing practices part 820) while working on Health Imaging products.

End to end validation of GMP, GLP, GCP systems to ensure they meet the necessary standards and regulations set by the FDA.

Working knowledge of Good Automated Manufacturing Practices (GAMP 5) risk-based approach

Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality assurance and data integrity to, and FDA challenge.

Working knowledge of cGMP parts 210/211 for validating manufacturing facilities, processing, packing requirements.

Involved in Data Migration, using strategies and procedures to ensure the data is consistent and no anomalies in the data, performing data cleansing activities to improve the data quality.

Knowledge of EMA (European medicines agency), MHRA (Medicines & Health Care Regulatory agency), PDMA (Prescription drugs Marketing Act) and ICH quality guidelines covering critical Product quality, design, process and control strategy attributes.

Knowledge of QUMAS Doc Compliance, medical device quality management system (QMS), a regulatory content management for electronic control of all documentation and QUMAS Process Compliance, a workflow and process management for Deviations, supporting CAPA implementation, Change Control, Audit and working knowledge of Documentum (Enterprise Content Management)

Authored and Reviewed equipment validation protocols, IQ, OQ and PQ

Involved in Validating Reports developed in Cognos using SQL Queries.

Co-ordinated and Performed Production deployments consisting of objects and SQL executions.

Identifying, Tracking Issues and Problem Resolution using ALM, JIRA.

Performed Risk Assessments based on failure mode effects analysis (FMEA) business risk and meeting regulatory requirements.

TECHNICAL SKILLS:

Database

Oracle 8i, SQL Navigator, SQL Developer, Toad, MS-Access, MS-SQL Server 2005, MySQL and DB2

Middleware

Webmethods

Validation Tools

Selenium, Unified Functional Testing (QTP), Win Runner 7.6/6.0, Load Runner7.8/6.0, Rational ClearQuest, and Microsoft Test Manager 2013

Electronic Document Management Systems

Documentum, Word Press, SharePoint, Sitecore, Umbraco,

E-Commerce, QUMAS, Veeva Vault (RIM, eTMF), Trackwise

IT Service Management Tools

Remedy, ServiceNow

Contract Systems

Model N, CARS (Revitas)

Bug Tracking System

HP ALM Vera, Test Director 8.0/7.x, Harvest, PVCS tracker, Clear Quest, DDTS, Jira, Spira

ERP Tools

SAP ECC, SAP S/4 HANA

Mobile Devices

Android, blackberry, Windows and Apple

Professional Experience

Bristol Myers Squibb --- Validation Lead/Business Analyst March 2021 to Present

Bristol Myers Squibb is the world’s leading biopharma company firmly focused on its mission to discover, develop, and deliver innovative medicines to patients with serious diseases that transform patients' lives through science.

Providing CSV support for implementation and validation of GxP systems in accordance with corporate policies and procedure.

Involved in the Vendor (Supplier) Assessment process, identifying the supplier risk and the overall risk of the system being validated.

Involved in Data Migration, including authoring a data migration plan containing Data Quality Assurance procedures of the Extract, Transform, and Load process and comparison of the source and target data using the db compare tool.

Hands-on experience in orchestrating end-to-end Validation Lifecycle Implementation for LIMS, EMES, SAP, and Veeva Vault Quality Vault software systems.

Hands-on experience testing and verification of medical devices/instruments, verifying design requirements and functional requirements for the specific intended use or application have been fulfilled.

Hands-on experience with Manufacturing Execution Systems implementation of the Syncade Smart Operations Management Suite by Emerson Process Management, covering configuration and customization to meet BMS requirements. EMES supports document management, tracking of equipment status, material tracking and handling, order and workflow management, quality and exception review management, electronic batch reporting & recipe authoring and electronic recipe execution.

Ensure Perinatal and newborn care regulations consisting of guidelines and standards have been validated successfully.

Prepared highly Complex Test Plans Validating Contracts, Chargebacks, Membership, Medicaid, Government pricing components of Model N.

Validation of Commercial and Government Contracts, Pricing, Chargebacks, Rebates that impact the government pricing Calculations involved creation of test data in SAP, Model N.

Involved in Pre and Post execution review of test scripts and providing feedback.

Co-ordinated System Testing, User Acceptance Testing with different cross functional teams.

Knowledge of Medicaid programs/invoicing and government pricing processes and calculations.

Involved in the preparation of test data for the execution of complex testing scripts and executing the same.

Involved in integration testing of other third-party applications, validating outbound wholesaler data.

Provided required support whenever needed, mostly during system upgrades.

Validated the Report so that the record number, Headers i.e. column names displayed in the created Report is the same as the records displayed in the Query

Cognos Reports were manually analyzed by validating some records in the beginning, some records in the middle, and lastly, some records in the end to ensure that the same records are being displayed in the Report and also in the executed Query.

Used SAP for creating Customer data and executing the billing cycle for Chargebacks

Involved in EDI Validation (X12 Format), verifying the Contracts (845’s) and Chargebacks (849s) data received by the Wholesaler.

Merck --- Validation Lead/Business Analyst Nov 2016 to March 2021

Merck is one of the leading pharmaceutical companies implementing Model N Contracts Management containing Contracts pricing, Govt pricing, Medicaid, Medicare. Involved in multiple projects as a Validation lead/BA.

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare test requirements.

System Validation performed using the GAMP 5 risk-based approach evaluating and categorizing the system.

Involved in Interface Validation using CARS, Model N and other third-party applications.

Performed Membership, Contracts Management, Customer Management, Chargeback Validation in Model N

Validated Commercial and Government Contracts, Pricing, Chargebacks, Rebates. that impact the government pricing Calculations.

Involved in Pre and Post execution review of test scripts.

Co-ordinated System Testing, User Acceptance Testing with different cross functional teams.

Knowledge of Medicaid programs/invoicing and government pricing processes and calculations.

Involved in preparation of test data for execution of complex testing scripts and executing the same.

Worked on Validation of Model N Reports and reports generated in Jorvak Analytics & Reporting (JAR)

Co-ordinated and Performed Production deployments using SVN (Subversion), Bitbucket, SQL Navigator for execution of SQL Scripts.

Hands on experience using Veeva Vault RIM managing global regulatory information systems for multiple Products.

Glaxo Smith Kline --- Validation Lead/Business Analyst Oct 2014 to Oct 2016

Glaxo Smith Kline is one of the leading Pharmaceutical companies implementing CARS Contracts Management containing Contracts pricing, Govt pricing with eCommerce integration. This is an eCommerce platform where multiple systems have been integrated in to one.

Responsibilities/Accomplishments:

Involved in Authoring, Reviewing, Updating Validation Plan, Validation Scripts and Validation reports.

Involved in Interface Validation using eCommerce, CARS and other third-party applications.

Prepared Low level Validation Scripts covering Contracts, Ship To Accounts, and Membership areas

Used Hybris for creating Customer data, Products and Pricing

Verified the data received, processed and sent by Hybris, CARS, E1 interfaces (Ship to account, bill to account, Contract Membership Requests)

Hands-on experience in orchestrating end-to-end Validation Lifecycle Implementation for integration with SAP ECC systems.

Verified Model N integration with CRM module Business Partner (wholesalers, Direct Customers, Indirect Customers) created in SAP ECC with all required identifiers. Batch Job executed successfully to send Customer info. Ensured the customer data is received by the middleware and then to the Actual System.

Involved in setting up test environment and Creation of Validation data for Trading Partners, Contracts.

Involved in Pre and Post execution review of test scripts and providing feedback.

Co-ordinated System Testing, User Acceptance Testing with different cross functional teams.

Knowledge of Medicaid programs/invoicing and government pricing processes and calculations.Involved in preparation of test data for execution of complex testing scripts and executing the same.

MRY – Senior QA Analyst June 2011 to Sept 2014

MRY is a creative and technology agency dedicated to making brands remarkable. MRY works with clients to give consumers something worth talking about—brand content that sparks emotion that adds value and inspires action.

Responsibilities/Accomplishments:

Worked with User Experience, Business analysts and Project Managers to gather and prepare Validation requirements for multiple projects simultaneously.

Interacted with Clients in defining and Validating the requirements.

Validation performed in accordance with the Quality system regulations for Medical devices (Part 820) and CFR part 11.

Collaborate with the User Experience teams in making usability decisions on websites/mobile

Involved in A/B testing of Campaigns, Newsletters

Collaborate with the Clients (Financial, Pharmaceutical, in preparation of functional requirements, user requirements, data set up, setting up user acceptance testing etc

Performed functionality testing, UI on Mobile devices for responsiveness.

Celgene Pharmaceuticals --- Validation/Quality Engineer April 2009 to May 2011

Celgene Corp. is a pharmaceutical company primarily engaged in the discovery, development and commercialization of small molecule drugs designed to treat cancer and immunological diseases through gene and protein regulation. Celgene’s pharmaceutical products,

Responsibilities/Accomplishments:

Worked with Subject Matter Experts and developers in finalizing the business requirements

Created Automated Test Scripts using Quick Test Professional 10.0 based on the Requirements listed in HP Quality Center.

Used automation framework for a standard approach to drive and execute the scripts.

Single data table to retrieve data for all the actions involved for one complete requirement.

Created and used user defined functions and also used Regular Expressions

Validated the Report so that the record number, Headers i.e. column names displayed in the created Report is the same as the records displayed in the Query

Retrieved data from the Mainframe application.

Performed mobile testing on device platforms such as Android, RIM and Apple and also on simulators

Environment: Quick Test Professional 10.0 and HP Quality Center 9.0, ERP, PegaRules Process Commander 5, SQL Server 2005, CallMaster FX-TDM, Cognos and Internet Explorer

Bristol-Myers Squibb Company --- Senior Validation Engineer Jan 2007 to Mar 2009

Bristol-Myers Squibb is one of the leading Pharmaceutical companies implementing Model N Contracts Management and Government Pricing for BMS and NOVO Realms

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare Validation requirements

Scheduled Execution of the Baseline Validation Scripts regularly using Test Run Scheduler

Involved in Interface Validation using SAP, Model N and other third party applications.

Prepared Low level Test Validation covering Contracts, Chargebacks, and Membership components of Model N

Validation of Commercial and Government Contracts, Pricing, Chargebacks, Rebates that impact the government pricing Calculations involved creation of test data in SAP, Model N.

Co-ordinated System Testing, User Acceptance Testing with different cross functional teams.

Knowledge of Medicaid programs/invoicing and government pricing processes and calculations.

Involved in preparation of test data for execution of complex testing scripts and executing the same.

Validated the Report so that the record number, Headers i.e. column names displayed in the created Report is the same as the records displayed in the Query

Cognos Reports were manually analyzed by validating some records in the beginning, some records in the middle and lastly some records in the end to ensure that the same records are being displayed in the Report and also in the executed Query.

Used SAP for creating Customer data and executing the billing cycle for Chargebacks

Involved in EDI Validation (X12 Format) verifying the Contracts (845’s) and Chargebacks (849’s) data received by the Wholesaler.

Worked closely with the GXS team in resolving the EDI issues.

Used Toad for performing Back end Validation for Reports

Verified the data received, processed and sent by Middle ware (Webmethods)

Novartis Pharmaceuticals - Validation Engineer Oct 2006 to Dec 2006

The CARE (Clozaril Administration Registry Enrollment) Application is a Clinical Trials Application in which the blood Values of the Patients who are on the Clozaril drug are being Monitored. There are several kinds of Users Accessing the System with different privileges.

Responsibilities/Accomplishments:

Leading the QA Effort on the Clinical Trials Application

Developing Manual Scripts basing on the Requirements documented in the URS

Pfizer Inc --- Quality Assurance Engineer July 2004 to Sept 2006

Project: Field Force org (FFO)

The FFO Project is a project for the Pfizer Sales force. Around 120 applications including Sherlock, Betsy 3.1 and Olos are part of the 8 Images or Roles that are part of the project. The platform for these Images or Roles is being changed from windows 2000 to Windows XP SP1. These Images would be installed on the laptops and Tablets basing on the Roles they represent.

Responsibilities/Accomplishments:

Analyzed the Functional Design documentation, User Requirements and

Technical Requirements Specifications.

Performed Installation Validation on the Applications that have been packaged using Wise Package Studio 5.5

Generated QTP Scripts with Standard, Text, Bitmap, Table Checkpoints and also Synchronization Points

Scripts were parameterized using the DataTable parameters, Environment Variables and Random Number Parameters

Kodak, Allendale, NJ -- Validation Engineer Aug 03 to June 04

Project Worked: Direct View (Medical Imaging)

Web-based application consolidates reading, reviewing DICOM and non-DICOM images, 3D processing, archiving and distribution. Archiving and viewing for DICOM images.

Responsibilities/ Accomplishments:

Validation performed in accordance with Quality system regulations for Medical devices (Part 820).

Provided services in compliance with the 21 CFR Part 11 Regulations in its System Development Life Cycle (SDLC) and SQA services to assure successful data quality assurance and data integrity to any FDA challenge.

Installation Qualification, Operational Qualification and Performance Qualification Procedures have been documented and followed.

The framework for Monitoring field Trials, Electronic Records and signatures FDA Auditing of Computerized Systems and 21 CFR Part 11.

Supported the successful implementation of manufacturing and laboratory equipment.

Environment: Windows 2000 professional, ObjectStore, Visual C++, Clear Quest and DOORS.

EDUCATION

Masters in Commerce, INDIA

Masters in Information Systems, Australia

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