﻿CONTACT ME AT
 +91 8546826279
 Vaibhava.archana15@gmail.com
 Bangalore
 
EDUCATION
    B.E. in Electronics &amp; Communication from VTU, Belgaum in 2011 
CORE COMPETENCIES
    Defect Management 
    Application &amp; Technical Support
    Scrum &amp; Agile Methodologies
    Project Execution
    Test Planning/Case Execution
    Software Bugs and Defects
    Software Quality Assurance
     QA/UAT 
    Client/ Stakeholder Management 
    Team Management/ Mentoring
TECHNICAL SKILLS
Manual Testing, Functional Testing, ETL Testing, Database Testing &amp; Data Migration Testing
Pharmacovigilance
SQL
Computer System Validation, Veeva Vault
Clinical Data Management
HP ALM, JIRA &amp; Bugzilla
CTMS
IRT Module, RTSM and RCSM
 
VAIBHAVA VATSAL
Senior Consultant
A result-oriented professional targeting challenging assignments in Computer System Validation, IRT Testing, RTSM, RCSM, CTMS, CDM Testing &amp; Pharmacovigilance Testing with an organization of high repute
PROFILE SUMMARY 
A high-energy technocrat with 12+ years of experience in Software Testing; worked on various industry verticals – (CRM &amp; CRO) Life Science, Health Care (IRT Module, RTSM and RCSM) and Pharmacovigilance (Drug Safety) &amp; CTMS
Understanding of SDLC &amp; STLC right from requirement analysis, documentation (functional specifications, technical design), coding and testing (preparation of test cases along with implementation) to maintenance of proposed applications
Showcased excellent aptitude in managing complex technology projects and in managing multiple stakeholders, priorities, resources, escalation &amp; risks throughout the project lifecycle; successfully executed projects like CTMS, ArisG, LSMV &amp; LSRA, IRT, RTSM, RCSM, APMS (USA).
Hands-on experience in Black Box Testing using Manual Testing (Functional Testing, System Testing, User Acceptance Testing (UAT), Regression Testing, Re-Testing) and Report Testing (IRT report &amp; Drug Safety report)
Proven success in incorporating industry best practices, techniques, and methodology into existing testing processes for effective bug fixing &amp; resolution of issues
Strong strategic aptitude with proven capability in establishing the quality assurance program including general criteria for system reviews, a software metrics and measurement program that included software quality, estimation, benchmarking, productivity, risk analysis, and cost information for software developers and business
Excellence in formulating software testing plans covering resource requirements, scheduling assumptions, and scope based on inputs from Development, Sales, and System Test Management which includes coordinating test plans across multiple test organizations and facilities
Possess excellent analytical, problem-solving and organizational skills &amp; has the capability to work independently and handle multiple projects
TECHNICAL PURVIEW
Experience in using Jira Test Management tools, HP ALM and SPIRA Team
Knowledge of: 
Computer System Validation (CSV), Protocols for IQ, OQ &amp; PQ in compliance with GxP and company Standard Operating Procedures (SOPs)
Agile- Scrum, V-Model &amp; Waterfall Model
Pharmaceutical regulations FDA 21 CFR Part 11 &amp; Annex11
CTMS, Veeva Vault, Clinical Data Management, RTSM, RCSM, Pharmacovigilance &amp; Drug Safety.
Case Processing and ICSR Processing
Risk Assessment and Risk based Approach.
GAMP5, Change Control, Risked Based Validation &amp; Validation Process.
Bug Lifecycle &amp; Black Box Test Design Techniques (BVA, EP), Test Reporting, Validation Report, Validation Plan, Test Summary and Traceability Matrix
Selenium Framework to execute the Test Case
Conceptual Knowledge of ETL Testing, DWH Testing &amp; Database Testing
SQL Queries
Basic Python Scripting
Basic UNIX Commands
Closeout reports, Report Validation &amp; document validation
Using Confluence, NetSuite &amp; Neuron
LSMV &amp; LSRA application
ArisG &amp; Argus safety 
Drug Safety report validation (PBRER, PSUR, SUSAR, ADR and so on)
Worked on Rave, Inform, Non-eCRF, EDC Data Transfer Task, Medidata as well as verifying XML &amp; CSV file
NOTABLE ACCOMPLISHMENTS ACROSS THE CAREER
Participated in several internal events on innovative ideas to improve the product &amp; test process as well as organized couple of ideation events within team and presented the same on the events 
Supported the Assistant Program Manager &amp; Leads for testing, evaluating and systems engineering in all meetings 
Key member of the product-quality team for the development &amp; execution of test scenarios and cases for all coding projects
Developed a Best Practice tool for testing third-party interfaces; created a concise Install Evaluation Document
Established a user-friendly defect management sheet to track internal defects within the releases
WORK EXPERIENCE
Dec’22 to till date: Senior Consultant
Spotline Inc., Bangalore
Skills:  Computer System Validation, Veeva Vault,Manual Testing, CTMS, SQL, HP ALM and JIRA
Oct’21-Aug’22: Senior Consultant
Aris Global, Bangalore
Skills:  Computer System Validation, Veeva Vault, Manual Testing, ETL, Data Migration&amp; Functional Testing, SQL, HP ALM and JIRA
Jan’21-Oct’21: Software Test Engineer III
Signant Health, Hyderabad
Skills: Computer System Validation, Manual Testing, Functional Testing, SQL, HP ALM and JIRA
Aug’13-Dec’20: Senior Test Engineer
Cenduit India Services, (IQVIA Business) Bangalore
Growth Path
Aug’13- Mar’15: Test Engineer
Apr’15-Dec’20: Senior Test Engineer
Skills:  Computer System Validation, Manual Testing, Functional Testing, SQL, HP ALM and JIRA
Feb’11-Jul’13: Software Test Engineer
i2soft Technologies, Bangalore
Responsibilities:  
Skills:  Functional Testing, Manual Testing, SQL
Key Result Areas:    
Analyzed functional &amp; technical specifications and Data Mapping documents provided by the clients 
Developed test cases for the entire functionality
Performed Manual Testing, Functional Testing, Data Migration Testing &amp; ETL Testing for the application based on the test conditions
Ensured the Environment Readiness &amp; performed Smoke Test
Case Processing and ISCR processing in LSMV and LSRA Report Testing, Pharmacovigilance Testing
Created the Test data during test execution
Worked on Bug Reporting, Test Reporting, Traceability Matrix, Issue Log &amp; Data Validation
Followed Computer Systems Validation, Validation Project Plan, URS, UAT, Periodic Review Report, and Validation Summary Report
Developed documents &amp; executed lifecycle documents such as Validation Plans, Specifications (URS, FRS, FS, FDS), Risk Assessment, Qualification Protocols (IQ, OQ, PQ), Traceability Matrix and Summary Report supporting.
Completed Test &amp; Defect Management through HP ALM and JIRA
Worked with other members of the quality group &amp; organization to ensure tactical execution of quality protocols and SOPs to minimize risk to the business 
Directed all operations which include setting definition of test estimation criteria, prioritizing test cases and reviewing the test reports &amp; testing artefacts 
Updated the regression pack to provide the best application coverage; supervised the Teams and ensured timely delivery for each regression cycle 
Conducted Defect Status Meetings along with Business Analyst, Developers, and the Project Manager 
Defined QA policies, quality improvement processes &amp; best practices 
Participated in cross-functional team discussions to help improve overall service quality, provided input for a go/no-go decision on release readiness, reviews and communicated status to stakeholders
SOFT SKILLS
Interpersonal Skills/ Effective Communicator/ Positive Attitude/ Analytical Skills/ Quick Learner/ Team Player/ Leader
PERSONAL DETAILS
Date of Birth: 31st January 1986 
Languages Known: English &amp; Hindi 
Address: Electronic City, Bangalore-560100
                                                                    PFB the Annexure for Projects details
ANNEXURE
Project 1: CTMS
Organization: Spotline INC.
Client:Pharma clients
Duration: Dec’21-Present
Position:Senior Consultant
Description:  CTMS administration include: setting up new user accounts, web site control and maintenance, business documentation control and maintenance, system testing and maintenance of future enhancement documentation. Provide business support to all CTMS users by problem solving issues, from onset to resolution, using applicable software. Enter set up data on a trial into the CTMS, accurately and within given time frames.  Includes continuous communication either via e-mail, phone calls, or face-to-face interaction with project managers from start to finish of trials.
Project 1: ArisG, LSMV &amp; LSRA
Organization: Aris Global, Bangalore
Client:Pharma clients
Duration: Oct’21-Aug’22
Position:Senior Consultant
Description: LSMV (LIFESPHEREMultiVigilance) is developed in partnership with the world’s best life sciences companies. LifeSphere MultiVigilance is an end-to-end, automated safety system that helps hundreds of pharmacovigilance teams around the world to save time and effort, ensure future-proof compliance, and keep global teams aligned
LSRA (LifeSphere Reporting and Analytics) Support ad hoc inquiries &amp; proactive case management with faster, more flexible reporting and analytics LifeSphere Reporting and Analytics helps to seamlessly integrate safety data, reporting, and analytics in a single solution, to drive more efficient reporting, and unlock powerful safety insights
Project 2: IRT
Organization: Signant Health, Hyderabad
Client: Pharma clients
Duration: Jan’21-Oct’21
Position: Software Test Engineer III
Description: IRT &amp; IWRS system is used in Clinical Trials Research. This functionality enrolls the patient and randomize a patient. Randomization works criteria, randomization section and treatment group. Medicines are assigned to patient according to treatment arm, developed initial supply, Re-supply, Distribution order task, In-Transit and Shipment Confirmation Task for medicine (Material) management. This functionality is used in un-blinding and blinding treatment, Drop patient. Different algorithms are available ranging from simple to highly complex
Project 3: CIRT 1.x &amp; 2.x
Organization: Cenduit India Services, (IQVIA Business), Bangalore
Client: Pharma Clients
Duration: Aug’13-Dec’20 
Position: Senior Test Engineer
Description: CIRT tool is a product for the Life Science Domain. This is an IVRS as well as Web Application (IWRS). This system is used in Clinical Trials Research. This functionality also enrolls the patient and randomize a patient. Randomization works the same way as in the previous project
Project 4: APMS, USA
Organization: i2soft Technologies, Bangalore 
Client: Louisville, United States.
Duration: Feb’11-Jul’13
Position: Software Test Engineer
Description: APMS (Automated Pharma Management System) is ERP system which works on user-friendly medical application software which has various features to maintain the records. This application is time saving and can be easily maintained. This software provides advanced features which is not available in today’s market. Earlier user used to face lot of problems to maintain records manually and also those users who are actually using some software have to maintain their store database. 



