KPMG is an Anglo-Dutch multinational professional services network, and one of the Big Four accounting organizations. Headquartered in Amstelveen, the Netherlands, although incorporated in the United Kingdom, KPMG is a network of firms in 147 countries, with over 227,000 employees and has three lines of services: financial audit, tax, and advisory.

Expleo India (previous SQS) is a group of companies throughout the world with headquarters based in Germany. Expleo basically caters for testing of software and devices in various domains. Our client is Abbvie Pharmaceuticals a healthcare company with variety of medical devices and software in use.• Abbvie pharmaceuticals is one of the leading research-based pharmaceutical manufacturer and sister concern of Abbott Laboratories.• Goal of the project is to author various computer system validation documents required by medical software and medical devices. • Gather requirements from the Business System Owner, IT System Owner and the Software Qulaity Assurance representative for new implementations as well as enhancements.• Active member of the System Life Cycle (SLC) team at Abbvie.• Used software of Application Delivery and approval management (ADAM) and Demand Release Change (D/R/C) software for document authoring.• Responsible for authoring various Computer System Validation documents like URS, FRS, Test Protocols, Trace Matrix and Validation Summary report.• Responsible for authoring the Change Request and carry out any pre SLC activities like Business Impact Analysis, System Charachterization and GxP Assessment.• Work as a Business Analyst as per demand.• Actively involved in use on GAMP 5 guidelines for document authoring.• Worked on the pilot project in implementing JIRA at Abbvie for SLC team.• Used JIRA for time tracking and time spent in authoring documents.• Involved in use of Kanban Boards method for tracking and traceability.• Involved in checking and making sure that the documents are in align with the 21 CFR Part 11 and European Union (EU), Food and Drug Administration (FDA) guidelines.• Used Abbvie Quality Center (AQC) for logging of test results and defects in given system.• Responsible for maintaining the compliance of documents as per the Good documentation Practices (GDP), GxP guidelines.

Snyder Technologies is consulting firm with headquarters based in PA, United States. It has its office in Delhi-NCR. Our main client was ICONplc in healthcare domain.• ICONplc is one of the leading Clinical Research Organization (CRO) with headquarters in Dublin, Ireland.• Goal of the project was to review and approve the various documents created for various clinical studies for our client ICONplc.• Responsible for conducting various QA related activities for research studies.• Concentrate on the GDP factors and make comments regarding the issues found which the respective Technical Project Manager (TPM) would correct them.• Research studies would be mainly concerned with ITG, Medical imaging studies (IMI) and ITG Legacy.• Check for the compliance of the research study according to the guidelines laid down by FDA in 21 CFR part 11 and GDP guidelines.• Check the consistency and reliability of the study taking in mind the versions and references• Maintain ER and ES with the help of MIRA software for IMI.• Check the accuracy and accountability of the tests executed using Test manager documentation for IMI.

Bizmatics is one of the leading companies in manufacturing of Electronic Medical Records (EMR) software. Software developed by the company is called “PrognoCIS, This software mainly caters the needs for follows the regulations of laid down in 21 CFR by the FDA for our US customers.• Goal of the project was to test and execute test scripts for various enhancements and bug fixes reported by the customers.• PrognoCIS software is mainly a workflow manager for EMR, EHR (Electronic Health Records) and Billing for the clients.• Part of a team of 6 members for EMR and 3 for billing based in Mumbai, also worked hand in hand with the development team, the tech support and the technical documentation team• Proved to be a liaison between the customers and the developers wherever necessary.• Carried out manual as well as automated testing.• Test for different scenarios and in charge for developing various testing strategies.• Carry out database testing with use of SQL queries in SQL server.

CIL is one of the leading manufacturers of isotopes of Carbon and Oxygen• The goal was to test and validate the Galaxie, Quadera and Quadstar software used for GC and Mass Spectrometer and to justify their compliance with cGMP and 21 CFR part 11 guidelines.• One of the major functions was testing of the functionality of the software to analyze the input given by the Gas Chromatographs or mass spectrometers from a quality standpoint.• Authored the Functional Requirement Specification (FRS) ,User requirement specification (URS), Validation Master Plan (VMP) and also maintain Requirement Traceability Matrix (RTM) • Created the risk assessment plan and carried out gap analysis wherever necessary and provide solutions to mitigate the risk. Key player in the team for CAPA

DoseEdge is pharmacy workflow management application by Baxter. It helps improve the pharmacist understanding of the specific workflow required in preparation of a patient specific doses in hospitals• Goal was to improve the efficiency of the application and increase its use in the market by increasing its ability to be customized.• Helped to reduce the defects in the system by more than 75% and tested for the efficiency and functionality of the system and also strive hard to maintain the quality of the system.• Tracked the recorded defects and the implemented resolution in a tracking system called DOTS (Dose Order Tracking System) and implemented DoseEdge for more than 200 customers.• Create automated test scripts using Selenium testing tools and also set up Proof of Concept (POC) servers.• Thorough understanding of business processes and creates business cases for them along with maintaining a requirement traceability matrix (RTM) to keep a track of the requirements from stakeholders. • Worked in a cross-functional environment starting from server installation to actual go live.• Developed labels using VB code for more than 40 Customers (Hospitals) using Seagull driver.• Part of the customer integration services (CIS) team, work hard towards Quality Assurance (QA)• Co-author of Baxter’s Quality Assurance system called Team Centre Unified (TcU) and also used Team Foundation Server (TFS) for Electronic document management (EDMS).• Formulating logic in working of the Dose Logic Engine (DLE) rules and firing of various actions, action groups depending on the triggers provided in the raw feed.• Writing simple and complex SQL queries to find unique cases in the hospital database.• Examined various failure scenarios and came up with strategies and plans to eliminate them.