QA Test Lead, Validation Specialist, Exposure in Automation using HP U

Professional Summary

Overall **+ years of IT experience in Quality Assurance and Software Testing of various business applications in Client/Server environments, Data Warehousing and Business Intelligence solutions and Web based applications.

4+ years of experience in Life Sciences industry and worked with various clients such as AstraZeneca, Amgen Inc and Mylan Inc during this tenure

Expertise in Validated and Non-validated system testing in life sciences domain and thorough knowledge on GxP validated system process and requirements

Specialized in 21 CFR Part 11, 210, 211 and Experience in Verification and validation process

Expertise in writing Validation Plan, Test Plans, Test Strategy, Test Procedures, Test cases, RTMs, Defect status reports and Test Summary report.

Expertise in Validated and Non-validated system testing in life sciences domain and thorough knowledge on GxP validated system process and requirements

Worked in various domains such as Logistics, Life Sciences, Banking and Insurance

Rich experienced in Functional/System testing, Validation testing, Reports testing, Database testing, Data warehouse testing, Integration testing, Regression testing, Black Box testing, Smoke testing, browser compatibility testing, UAT and GUI testing.

Experience in ISM Change Management process and EDMQ for document workflow

Expertise in Test management using Test Management Tool HP ALM 11

Excellent knowledge of System Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Defect Life Cycle.

Good amount of experience on co-ordination with client in terms of discussing about project scope, getting requirement, status meeting with client, part of decision making meetings and doing review and getting approval and all.

Proficiency in Defect management, including Defect creation, modification, tracking, and reporting using Industry Standard Tools like HP Quality Center

Adept on database query tools such as TOAD, SQL Plus and SQL Developer.

Knowledge on the phases of V-Model, agile methodology and traditional Waterfall methodology.

Excellent interpersonal, communication, documentation and presentation skills.

Education and Certifications

Title of the Degree with Branch

College/University

Year of Passing

Bachelor of Computer Science & Engineering.

Anna University

2006.

Technical Skills

Operating Systems

Windows XP, Windows 7, Mac and Linux

Testing Methodologies

Data integrity and validation testing, Functional Testing, Regression Testing, UAT Testing, Integration Testing

Data base

Oracle, Sql Server 2005 & 08, TD 13.11, IBM Studio DB2

Test management Tools

Bugzilla, TFS, HP Quality Center 9.2, 10.0 and 11.0, ALM 12

Automation

QTP and UFT 12.02 - Learner level (Know about the tool and structure and managed two automation projects)

ETL Tools

Reporting Tools

Data Stage 7.5, Informatica 9.1

Business Object 4.0 and Cognos 11

Certifications

Certified Scrum Master (CSM) with active membership till Oct 2018

Mylan Inc. Feb 2017 – Till Date

Responsibility:

Test Lead for run app towers

Review IQ/OQ/PQ test scripts and Test runs in accordance with GDP stand point and 21 CFR Part 11 for electronic signature and documents

Support validation activities for run app’s in all the towers and work on CRQ’s from LIMS in Lab Informatics tower

Work with Business, Technical and Testing teams to ensure project teams to complies with the SOP’ and the methodology

Support Functional, System, Integration and UAT Testing and generate and present the quality metrics.

Assist Developer, Tester, business for IT Quality services and process using HPALM 12 throughout the life cycle of the project.

Author and execute protocols and necessary documentation to complete verification and validation

Weekly connect with quality leadership team and provides updates, issues, risks and mitigation plan

Responsible for the deliverables

Project Description:

Mylan Run Validation Test Lead for around 9 towers and providing hands on in Lab Informatics tower for LIMS application.

Amgen Inc. Mar 2014 – Jan 2017

Responsibility as Validation Lead:

Review and identify gaps in the requirement

Prepare validation Plan and have it reviewed with business and QA SME’s

Review IQ/OQ/PQ test scripts and Test runs in accordance with GDP stand point and 21 CFR Part 11 for electronic signature and documents

Prepare OQ validation protocols and get it reviewed with Technical, Business and QA in EDMQ

Report discrepancy/deviation/incident

Prepare and review Traceability Matrix and get it reviewed and approved with Technical, Business and QA in EDMQ

Prepare Validation summary report for closure

Responsibility as Test Lead/System Tester:

Lead the system testing team

Understand and analysis functional requirements and estimate the effort.

Test management setup in HP ALM 12

Prepare Test Strategy Document for both GxP and Non-GxP systems

Prepare System test cases for both GxP and Non-GxP systems

Perform execution for system test cases

Prepare trace matrix to ensure the functional coverage

Managed the scope of automating the regression suites using HP UFT12.02

Project Details:

Veeva eTMF: GxP – Validation Project- eTMF is a collection, maintenance and storage of a TMF is a regulatory requirement and demonstrates compliance with GCP. Earlier it’s being used in EPIC system and then it will be migrated into new product called Veeva Vault which is cloud based system with user friendliness and enables active TMF management for real-time inspection readiness, visibility, and control.

DMP: GxP – Validation Project - DMP (Data Management Plan) System facilitates a streamlined and standard approach for edit check development. The basic functionality of the system is Creation of Checks, Update/Modification of Checks, and Review of checks and approval of checks.

DCO Migration – GCPS GCOIS (Model N) (Non-GxP): Amgen is in the process of migrating the entire application environments from Washington (USWA) to Las Vegas (USLV). As a part of this migration, all the GCPS environments have been migrated to the new location with the software upgrades. There are 7 environments to be migrated which includes Production

New Product Launch 2014 -15 (Non GxP): The goal of this project is to execute the data flow which will flow into various systems with respect to the new product launch and make sure the E2E flow is working without any flaw into the system. Data such as “Customer Master & Alignment, Product & Price and Nominal Sales etc.

CRIS Hazardous Material Inventory Statement Report: GxP – Validation Project – The scope of this project is to define Hazardous Inventory Statement Report for assessing the hazardous material Inventory level across all Amgen site research labs. The report shall be generated by the cognos with the data captured from CRIS database.

MassMutual Insurance Oct 2013 – Feb 2014

Role and Responsibilities:

Working in Data Aggregation ETL Testing project, responsible for understanding the Business Requirements/Project Specifications.

As a Test Lead involved in the requirement gathering, effort estimation, planning, execution and implementation.

Involving in the requirement walkthrough call with BSA and developers and provide the approval as a QA Lead

Responsible for the deliverables and managing team in offshore

Prepared Test Strategy and execution plan and have it reviewed with the larger audience and setup the approval process to get it approved before the execution.

Co-ordinate with the development from different source systems to sync up with the data load into QA/System environment and do the frequent follow up to get the status of load

Project Description:

Data Aggregation: The goal of the Data Aggregation Program is to extract policy data, demographics and values from various platforms and feed this data to a third-party vendor tool (Broadridge Investigo) for use by agents and home office support staff. Field agents use web applications provided and hosted by Broadridge Investigo to view client holdings and create client portfolio reports. The home office will use Cognos reporting tools that will run against a local copy of the Broadridge Investigo database IDM (Independent Data Model).

Organization: Infosys Nov 2010 – Oct 2013

Role and Responsibilities:

Working as Test Lead

Understanding the requirement, estimate and Prepare the Test plan and Strategy

Review and Execute the test script

Defect Tracking and monitoring in Quality center

Prepare Traceability Matrix for the test coverage

QA Sign off

Project Details:

Accounting/Data Management: This project involves in getting the data from different Insurance Source Interfaces and load the data into the General ledger table for accounting purpose through an application called BCTA and QMIRD. All transaction would be happening on the backend and ETL is involved on loading the data from QMIRD file server environment to DB2 (General ledger).

CIP Carrier Change (Data Transmission): This project involved in transmitting the balboa insurance data from different source system to QBE First with the use of ETL process.

Investment Policy Statement (IPS): The Investment Policy Statement (IPS) is a planning tool utilized in investment management to profile, capture and store portfolio investment policy including assets accepted and held at account opening, initial and ongoing investment objectives, risk tolerance, time horizon, client constraints, asset allocation and overall investment strategy

Organization: Cognizant Technology Solutions Feb 2010 – Nov 2010

Role and Responsibilities

Understanding the requirement and estimate the effort.

Test plan preparation and estimation

Task allocation to the resources

Control and monitoring the daily activities

Conduct daily standup meeting to discuss about the progress and issues.

Involved in preparation of End to End and Regression Test script

Involved in extensive End to End and Regression Testing.

Defect logging, Tracking and Monitoring which includes reviewing of defect, Priority and Severity

Co-coordinating with the developers to find out the issues in the data by doing data analysis and in terms of helping to understand the defect and reproduce.

Project Description:

Sapphire NCHOM: This project involved to allow the Marketing Companies to electronically submit to the Central DES the Adverse Event cases they receive, submit the cases to their regulatory authorities and other stakeholders, and track the processing of each case to ensure they meet their Regulatory Authority deadlines for reporting of cases

Organization: SRA Systems Ltd Jan 2007 – Jan 2010

Role and Responsibilities:

Understanding the requirement and identify gap in the requirements

Prepare and execute system and unit test scripts

Prepare requirement traceability matrix

Defects logging in Bugzilla

Handling the release in QA environment for testing

Defect Triage

QA Sign off

Project Details:

Breeze Card Web Ticketing System: It’s a web application that will allow customers to buy Breeze Cards, their Breeze Card accounts and add value to their cards from remote locations with the use of the internet

eLogistics: E-Logistics is a Web portal to handle the Transport Management System by providing the web interface for the entire customer to interact with the ADM and to provide them with standardized reporting templates and regular reports for tracking the details

Customer Image Specification (CIMSPEC): Apple Inc. is an American multinational corporation with a focus on designing and manufacturing consumer electronics and closely related software products. It involved in the process of entering data and configuration details will be captured and the screens will be like the Mac OS configuration screens to the extent possible in a web browser

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