Computer System Validation - QA lead

Abin

Authorized to work in the US for any employer(H4-EAD) Phone:847-***-****

Plainsboro, NJ. *******@*****.***

SUMMARY

Innovative and dynamic, Computer System Validation/QA lead and Business Systems Analyst with 10+ years of experience in IT industry. Has successful background in Regulated Industry Quality Assurance, Business Analysis, Technical Documentation, Data Analysis. Well versed in all phases of the Software Development Life Cycle, and proficient in the use of design tools in gathering, analyzing, and documenting requirement artifacts.

AREAS OF EXPERTISE

As a Validation Lead, authored and reviewed Validation deliverable's including Validation Change Request(Initiative), System Risk Assessments, Validation/Project/Migration/Sampling Plans, Supporting System Documentations, Validation Test Protocols, Requirement Traceability Matrix, User Acceptance tests, Validation summary reports and System Certification.

As a QA Test Lead, authored and maintained Test Documentation as per high level testing standards, Attended review meetings and Quality Control board meeting for continuous improvement of Software Quality.

As a Business Analyst, involved in gathering requirements, analyzed Business needs and specifications as per the stake holder’s expectations. As a part of Life Science domain application projects, drafted new requirements, reviewed and created baseline requirements in compliance with Computer System Validation procedures, 21 CFR part 11 compliant regulations and standard operating procedures.

Knowledge in Pharmacovigilance, Safety Surveillance and Manufacturing/ Operations systems such as Adverse Event Reporting Systems

Extensively worked on Manual Functional Testing, Exploratory Testing and Mobile testing.

Hands-on experience in User Acceptance Testing and training of end users. Defined and documented business training requirements for new product releases.

Experienced in Life Science and Banking industry.

Experienced in Water fall and Agile Methodology (Scrum) software development process.

Excellent Team worker with experience working with offshore and cross-functional teams.

Experienced in managing teams of Testers on projects. Comfortable to operate both independently and in a team environment.

Experienced in Quality Management Systems(QMS) and Document Management systems (DMS).

Excellent organization, analytical, planning and leadership skills.

Synchronized off- shore and Onsite teams between different time zones.

Exceptional ability to maintain and build client relationships, frequent travel meeting one on one with clients, able to comfortably converse with all facets in the client’s organization.

Good communication and customer service skills, Responsible, self-motivated and organized, excellent written, verbal skills and an effective presenter.

Well versed in broad range of technologies, including business process tools such Microsoft: Excel, PowerPoint, Outlook, Project, Visio and Word.

Educational Profile:

Bachelor of Engineering, Computer Science, University of Calicut, India(2005)

Technical Skills:

Operating Systems

Windows 98/2000/XP/Vista/7, Win 8, Win 10 -Unix, Mac, IOS

Programming Languages

C, Java,

RDBMS

MS SQL Server

Test Management Tools

HP ALM (Quality Center), JIRA

Business Process Modeling Tools

MS VISIO

Mobile Testing Tool

Perfecto

Documentation Tools

Service Now, SharePoint, MS Office (Word/Excel/Power Point/ Visio)

Experience Summary:

Project 1 – Abbvie Inc. North Chicago, IL

Cognizant Aug 2013 –Sep 2016

Project Name- ACE and ADAM Migration

Business Analyst / Validation Lead

ACE(Abbvie Consulting Express)

The ACE project is an initiative to unify and automate the Annual plan submission process from Business Owners in AbbVie. It is a Java GUI (front end) and Tibco BPM system to be implemented to streamline the current annual plan submission process by providing an automated workflow for creating, and routing Annual Plan requests, including Written Agreement Requests (WAR). Requestors will submit the Annual Plan request and receive the status updates in a JAVA based GUI.

ADAM Migration

ADAM (Application Delivery and Approval Manager) is an application change management system configured on the Service Now platform.

The main purpose and objective of the ADAM is to replace the existing Lotus Notes Packet Tracker Application (PTA) and to act as a house of information and documents that support the system change management process.

Roles and Responsibilities

Designed and authorized Validation Plan, Test Estimation, Requirement Traceability metrics, Validation Test Cases, Validation summary reports, Incident Report, Risk Assessment document, eRIM, DPP and System Certifications.

Gathered and defined Business Requirements and translated them to functional specifications for Web, and Mobile Applications.

Analyzed, optimized and prioritized the processes involved; prepared deliverables: Functional and Non-Functional Requirements Specification (FRD), Requirements Traceability Matrix (RTM).

Involved in Agile Methodology/Scrum based software development process.

As per Acceptance test–driven development (ATDD); defined and recorded the Acceptance criteria for the corresponding user stories.

Test management using Quality Center(ALM).

Reviewed and managed Approval Workflow in ADAM (Service Now) for all the authored documents.

Participated in Testing TIBCO BPM related communication.

Coordinated with stakeholders to prepare and execute UAT test scripts.

Effectively communicated test results to the senior management, other project managers, technical and non-technical members

Actively supported in preparation and reviewing all IQ, OQ, and PQ documentations

Regularly interacted with SQA to update and ensure all validation documents are as per the compliance.

Provided Post Implementation support by analyzing the issues, identifying the resource for issue resolution and interacting with cross functional team members.

Managed individuals and groups workload, project milestones and critical deliverable dates.

Successfully led, delivered multiple simultaneous projects within tight deadline.

Work with business stakeholders, product management, project manager and engineering team to determine test planning and requirements

Participated in internal audits for verifying the records and processes related to regulated computerized systems and regulated data

Project 2 – Abbott. North Chicago, IL

Cognizant Aug 2011–July 2013

Project Name - IAM / SNAPP PO

Validation Lead

IAM (Identity Access Management)

IAM is an application which was integrated with Oracle Identity Manger which controls the Identity access management of Abbott/Abbvie employees and contractors. It is a Service Request ticketing solution which can initiate and track incident, problem, changes. Abbott/Abbvie Information Technology Service Management has developed an Identity management system which integrated with Service ticketing solution which runs in Service Now Platform. Validation testing was conducted on the data flow in between OIM (Oracle identity Manager) and Service now

SNAPP PO

The SNAPP PO (Simplified Network Access to Payments and Purchasing) ” is an initiative to unify and automate the purchasing and check request process. It is a system used to provide real time tracking of SNAPP requests. The SNAPP PO Automation tool is a workflow based tool that will allow users to access an application to create a request and submit to Purchasing or Automated check requests The tool will enable the user to submit requests and will provide them status visibility for each request

Roles and Responsibilities

Designed and Authorize Test Plan, Migration Plan, Sampling Plan, Test Estimation, Requirement Traceability metrics, Validation test protocol, Test Execution summary, Incident Report, Risk Assessment document, eRIM, DPP and System Certifications.

Communicate effectively and provided a high level of customer service to clients through timely response to requests and proactive resolution of potential issues.

Actively contributed in identifying the Business rules and designing the business process documentations as well as SDLC documentations.

Worked with Development team to identify and document Web Service Requirements during the Design Phase.

Regularly interacted with SQA to update and ensure all validation documents are as per the compliance.

Created and maintained dashboard to help business units make informed decisions and develop actionable insights for Cross Functional teams

Very good experience in Good Documentation Procedures, and also in CSV, GxP, 21 CFR Part 11,

GAMP-5 and global Regulatory Regulations

Attended project review meetings and Quality Control board meetings for the continuous improvement of Software Quality.

Participated in internal audits for verifying the records and processes related to regulated computerized systems and regulated data

Reviewed and managed Approval Workflow in ServiceNow for all the authored documents

Designed and Reviewed Traceability Matrix to track Test Cases against the Requirements

Reviewed and Maintained track of Defects associated with the scripts through Incident Reports.

Actively supported in preparation and reviewing all IQ, OQ, and PQ documentations

Regularly interacted with SQA to update and ensure all validation documents are as per the compliance.

Prepare Test Summary Reports/Validation Summary reports on the actual results generated during Test Execution.

Reviewed test scenarios and test cases ensuring 100% end-to-end functional coverage

Involved in Agile Methodology/Scrum based software development process

Analysis and issue resolution after consulting with client for all issues reported by offshore team.

Defect reporting and tracking closure using Quality Center

Data management of performance test results using share point application.

Project 3– Capital One Account

Cognizant Pune, India

Hudson Bay Conversion Project Jan 2009 – July 2011

QA Analyst

Capital One Buys Hudson's Bay Card Portfolio with $1.3 Billion in Assets has become a strategic partner with Hudson Bay Corporation, Canada. Hudson Bay Corporation is the first Partner to prove Capital One’s retail partnership ability. It covers 4 strong banners Zellers, Fields, Home outfitters and Bay and over 600 stores with 2.5MM accounts. Capital One would be partnering with ZOOT and FDR Vendors for Acquisitions and Core processing streams.

Roles and Responsibilities

Involved in testing Credit Card Transaction Processing

Writing Test cases for various modules/applications and executing the same

Interact with users and document any changes in business requirements.

Prepare and review Test Plans, Test cases and Test scripts to test the application ensuring application compliance with requirements and able to manage action items.

Create final Test Summary reports; update Test Logs/ Issues log for reporting purpose.

Responsible for identifying and performing functional, regression and smoke test based on the scope of the changes made.

Served as a primary resource for all QA and Performance and UAT related tasks for multiple applications

Responsible for ensuring delivery of work from the offshore team.

Interacting with offshore team members to bridge any gap in functional understanding of the system as well as clarifying questions

Reviewed Business Requirement Documents and functional requirements.

Involved in Test Data Management by performing various transaction through Green screen.

Undertook regular knowledge sharing sessions within the team.

Project 4: GM, Canada Pune, India.

SAI Softek Services Pvt Ltd Mar 2008 to Sept 2008

Project Name- SPO

Mainframe Tester

Project Summary:

This project is basically a maintenance and support project involving activities like Production Support for batch jobs, batch monitoring and regular maintenance activities for Jobs and applications under Supply chain module. Involved as a Team Member for Service Requests, Cycle Monitoring, Remedy Report Generation and Base Support for the Supply Chain Service Modules

Create technical design recommendations for developing and integrating programs per functional specifications; incorporate security requirements and provide input to data flow, and understand and comply with Project Life Cycle Methodology and IT Control policies/Architectural standards in all planning steps.

Preparation of program specifications, overview documents & test plans, for enhancement requests Involved in preparation of Test Scenarios.

Maintain compliance with Change Management, Software Development Life Cycle and development standards including leading code reviews, developing and reviewing implementation plans and contingency plans

Project 5 – Guardian Life insurance, North America Bangalore, India

Covansys India Ltd, Bangalore (CSC) Aug 2005 -Feb 2008

Project Name- CLAIM FACTS

Mainframe Tester

Project Summary:

Claim Facts is an advanced computer application that administrator health insurance claims. It provides a database, which is a collection of data organized for search, and retrieval, online claims processing and a set of batch functions for reporting. The subsystems under Claim Facts system are Financial, Plan Holders, and EOB (Explanation of Benefits) customer service. All these sub-systems are highly integrated in terms of their functions and their shared data resources and interfaces

Support changes/applications post implementation by debugging, fixing, and participating in maintenance releases as needed.

Develop error free, highly efficient code that complies with all code standards and methodologies. Coding according to the specifications of Client.

Develop unit test plans and scripts and execute test scripts to ensure correctness.

Participate in code reviews and ensure that all solutions are aligned to defined architectural and functional specifications

Identify/troubleshoot application code-related issues; and review and provide feedback to the final user documentation

Evaluate service level issues and suggested enhancements escalated by Service Delivery Team to diagnose and address underlying system problems and inefficiencies

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