Bela Soni

609-***-****

HATFIELD, PA

Lead Tester – Project Manager – Software Delivery

Healthcare, Pharmaceutical & Clinical Research Industries

Program and Project Management Results-Oriented Professional experience working with Fortune 500 companies in the Healthcare and the Pharmaceutical industries. Proven abilities/experience in the areas of leadership, software development program/project management, process management, release/implementation/deployment management, education and training, software metrics, best current practices, and management.

SKILLS AND STRENGTHS:

Project Manager

Leadership

Problem Solving/Decision-Making

Program Management

Team Building

Risk and Opportunity Management

Process Management

Supervision/Management

Issues Identification/Resolution

Stakeholder Partnership

Peer Coaching/Mentoring

Written & Verbal Communications

Client Partnership

Project Organization

Problem/Change Management

Client Needs Analysis

Resource Coordination

Training Course Development/Delivery

Business Requirements Facilitation

Budget Management

Software Metrics Analysis & Reporting

Client Communications

Project Planning

Best Current Practices

Vendor Contract Negotiations

Project Tracking/Oversight

Project Documentation

Software Testing Process/Procedures

As a Lead tester/PM – Managed projects in following testing environment:

ETL Testing

User Acceptance testing,

EDI Testing

Web Testing

Performance Volume testing

Data Mining

Sarbanes-Oxley Act (SOX),

Clinical Practice/CFR Part 11

FDA regulatory (Drug management)

TECHNICAL SKILLS:

Operating Systems: MVS, Windows NT/2000 4.0/XP, UNIX, AS/400

RDBMS: Oracle 7.1/8i, SQL Server 6.5/7.0/2000, DB2 6.1/7.1,

Oracle E-Business Suite: Oracle 11i Client & Oracle 12i Client, SOP, UPK and Work instruction

Languages: C, C++, HTML, Power Builder, Java fundamentals

User Interfaces: Visual Basic 5.0/6.0, Visual Basic .NET, CICS, TIBCO Designer/XSD Browser

Internet Technologies: HTML, ASP.NET, Introduction to Java Beans, XML, SOAP, ESB channel service

Report Writers: Crystal reports 4.6, 7.0 and 8.5, RepGen

Special software/Tools: Visual source safe (VSS), Rep-Generator, Softech, NED, TSO, File-Aid, Platinum, Business

Object XI, Relational IBM Case Tools, Serena Dimensions, PVCS, Change Management Software – ISIM, New Endeavor Deployment (NED)

SDLC: Requirements gathering and documentation, Experience making Presentations to

stakeholders, Business process reengineering experience, Experience with user interface design including storyboards and mockups.

Tools: Microsoft Office suite, HP Quality Center and Quick Test Professional

Methodologies: Waterfall, Agile(SCRUM) and Hybrid Waterfall

Technical Skills: Change control, Electronic Document Management, GMP, 21 CFR Part 11, FDA, GXP,

LIMS, Track wise, Regulatory Requirements

Hardware/Computer: Networks IBM Workstations/servers and HP Net server LHPro servers, Token Ring and

Ethernet

Others: SharePoint, XML, Java Script, ADO.NET, Visio, Siperian XT, Siperian XU, Toad, Oracle SQL

developer.

PROFESSIONAL EXPERIENCE

G&W Laboratories- TEVA-Pharmaceutical Inc. – Sellersville PA May 2015 – Present

Software Project Lead [For Oracle & Electronic Document Implementation System (EDMS)]

Created, analyzes and executed complex, multi-platform Test plans, Test Script, Test Cases, Test Data needs for GXP/Non GXP compliance requirements.

Created and updated UPK’S/SOP document for Training new user in system.

Assessed test traceability of business requirements, developed test strategies and plans, supported User Acceptance and performance Volume testing, performed data mining,

Expertise in R11i and R12 SCM and Process Manufacturing modules (Order Management suite, Inventory, WMS, MSCA, Advanced Pricing, Quality, ERES, AME and OPM modules)

Identify and document instances where existing business processes may be streamlined or improved with guidance of the technology QA manager, verify implementation, monitor effectiveness and review output of tools and techniques to assess, report and mitigate risk and issues in technology used across MRL functional areas and partners. Provide support to the technology QA manager to help ensure that key technology vendors understand and meet minimum requirements set forth in the strategy.

Develop, maintain and distribute business process documentation to stakeholders.

Serve as team representative at designated meetings and respond to questions/tasks related to business process management/modeling Skills/Qualifications

Defect tracking, root cause analysis and prioritizing, status update through office suite, constantly update test matrix to keep the progress for Q-certification

Coordinate/manage projects and track project status, including: time, scope, cost, resources, issues, stakeholder communications and participation, certification reviews and risks.

Coordinate the completion of detailed requirements, design, build and test activities by managing the participation of responsible parties (GDCs, Systems Engineering Team and Service Delivery Team).

Provide information needed to plan work, release dates, milestones, communication points, and to baseline the plan. Assist in creating project plan and planned release dates, including change control and baseline for plan.

Work with other IT resources to complete activities in Design, Construction, Test, Enterprise Test, and to migrate solutions into production.

Worked with users, designers, programmers, stakeholder to create/analyze various required project documents and give feedback and recommendations on software usability and functionality thru out the project life cycle.

Management activities include team member task assignment and oversight, role definition and communication, project performance management, documentation of performance feedback to resource managers, and team-building activities.

Build credibility, establish report and maintain communication with stakeholders at multiple levels, including those external to the organization.

Created deliverables, responsibility report and preheated/posted in share point link as well as various meeting (Team meeting, PMO meeting)

Worked closely with Documentation & Validation Specialist to coordinate test efforts and review validation documentation.

Merck Bio-Pharmaceuticals – West Point, PA March 2011 – July 2014

Project Coordinator/Project Manager / Lead Tester

Responsible and accountable for the coordinated management of multiple SAP & MSPS projects directed toward strategic business and other organizational objectives.

Manages SAP & MSPS projects according to a defined project management methodology, following current standards for all phases, and adheres to phase review, governance and control steps.

Management activities include team member task assignment and oversight, role definition and communication, project performance management, documentation of performance feedback to resource managers, and team-building activities.

Build credibility, establish rapport, and maintain communication with stakeholders at multiple levels, including those external to the organization.

Define and initiate projects, and assign Project Managers to manage cost, schedule, and performance of component projects, while working to ensure the ultimate success and acceptance of the program.

Maintain SAP & MSPS continuous alignment of program scope with strategic business objectives, and make recommendations to modify the program to enhance effectiveness toward the business result or strategic intent.

Coach, mentor and lead personnel within a technical team environment.

Present periodic Dashboard reports on the current GXP/Non GXP program, future opportunities and client issues.

Seasoned professional, with outstanding project planning, execution, monitoring and resource balancing skills with ability to support multiple simultaneous projects in a matrix organizational structure.

Excel at communicating with stakeholders/project member to provide accurate reporting and information regarding the ongoing projects and initiatives.

Experienced in coordinating, negotiating and motivating outside vendors and off-shore resources in support of time line and IT project deliverables.

Participated in and supports to enforce IT methodologies, SDLC processes and standards reviews.

CIGNA Health Care Insurance – Philadelphia, PA April 2005 – February 2011

Sr. Business Analyst/Software Test Lead

Gathered, analyze, documented, and validated the needs of the business stakeholders

Worked as Principal conduit for managing system requirements between the business and the software development team throughout the duration of the project

Primarily involved in testing the complete End to End process of online reporting application for external\internal user of CIGNA core application. This is testing processes, testing the ETL process, the SSO batch processing and validation of data and the front-end application, Ownership/accountability of defects- escalation of issues for timely resolution.

Tested the success and accuracy of the ETL load processing to the Data warehouse based on requirement documentation, source to target mapping documents and physical and logical models as criteria.

Developed strategic partnerships with customers developing solid knowledge of business line, business plan, products, process and revenue streams, performed thorough Business/Systems Analysis and Solution Architecture Design leading to effective implementation of e-commerce server/portal and customizations of solutions as needed.

Expertise in Black Box, Functional, Systems, Regression, Integration, User-Interface, Database and Performance, security, firewall, compatibility, ETL process, password and encryption testing

Created/executed test case for web-services (ESB, Soap UI, Audit, Router) line testing.

Above all involved in requesting batch cycles and making sure that the entries which were made in the source came thru successfully to the target application or database.

Extensively used SQL Queries and Microsoft query for data validation, data migration to different platform and application.

Mentor, coordinator and leadership roles in creation off testing estimates, testing time line, sign off from testing point of view as well as resolving new/existing defects for CIGNA highly profile application.

Documentation of all the work done using Microsoft office products as well as Cigna quality gates documents which is required for internal/external auditing.

Lead a team of testers (onsite and off-site) to perform System, Regression and User Acceptance Testing manually

Weekly interaction with developers & business analysis to understand the application logic, business process, status meeting or defect meeting.

Converted regression script from Test Director to Quick Test Pro (QTP) for various application of CIGNA.

Created / managed the automation test plan, setting up test scenarios, test scripts for regression testing of Cigna's core application in Mercury Test Director as well as Quick Test pro.

United Health Care (UHC) – Basking Ridge, NJ August 2002 – March 2005

Sr. Business Process Analyst/Project Manager

Analyzing & understanding the current system, study similar systems by other vendors and suggest improvements that while maintaining current value to customers

Documents including Usability Matrix (based on business user interactions, current data requirements and associated tables and screens), Data Flow Diagrams, Use Cases (based on user and stakeholder interactions, inputs from existing business documents and proposed changes), Activity Diagrams, Data Definition for Workflow and Data Discovery Document were prepared as output at the end of the requirement gathering and planning stage.

Efficiently handle cross functional coordination, communicate requirements to the offshore software development team acting as a liaison between stakeholders and developers for efficient transition of knowledge obtained during the requirement gathering stage.

Tested conversion of Pega systems infrastructure with presentation in Visual Basic .NET system called COMET.

Managed 12 team member to make sure the testing process get successful

Developed & validated documented test plan/test strategy/Test cases for GUI based mainframe claims paying system (COMET & VETSS - Voice Enabled Self-Service systems also known as IVR)

Ownership & accountability of defects & escalation of issues for timely resolution

Participated in design analysis and pre-and post-installation reviews.

Communicated and worked with Development, Product Manager and QA Staff for various level of project.

IBM Local Services – Middle Town, NJ June 1998 – May 2002

Lead Software – Integration Analyst (AT&T Account)

Created-Validated test plans, test script & test cases for GUI & IVR applications.

Performed functionality, Regression testing & certified new software releases to support AT&T Life & GUI ordering system

Developed/Monitored time tracking & scheduling process to improve on-time delivery of projects

Validated, updated & maintained the Life Date Dictionary and Data Model Diagrams in Oracle database.

Resolved all issue during systems testing lifecycle via working co-operatively with user, developer and shareholder.

Team lead for Automation system test using SILK products

Trained team members on tool for implementation of AT&T Local Projects

Supported 24/7 maintenance of software in the production/test environment

EDUCATION

Bachelor of Science in Information Technology from Gujarat University India

PROFESSIONAL MEMBERSHIPS/CERTIFICATIONS

SQL & Oracle Certification

Professional Software Certification in Quality, Testing, Business analysis

Internal IT Auditing

ITIL (Information Technology Infrastructure Library) certification

Oracle E-Business Suite (11i &12i)

DEA Compliance (PHA40Ver 2.2)

SAP ERP Environment

Familiarity with Clinical Practice 21 CFR Part 11 & other FDA regulatory requirements as an applied to computer systems used in Clinical Trials.

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