Project Manager/Senior Software Validation Engineer

KEY ACCOMPLISHMENTS / SUMMARY:

Dedicated professional experience with over 10 years of Software Validation and Quality Engineer, in industries like HealthCare, bio/pharmaceutical, Insurance and Banking etc. Experience testing web-based and client server applications, data management system and Finance application using MS SQL and Oracle database in full SDLC environments. More then 8 years of experience as a Project lead in an AGILE environment. Expertise includes writing Test Plans, Test Scripts, Test Cases as well as executing them, Validation plan and summary report, Software Change request, Traceability Matrix and 21 CFR Part 11 Matrix. Proficient in both Manual and Automation Testing using automation tools such as Win Runner, some Load Runner and QTP. Kuntal Proven ability to work as part of a team, leading large scale testing projects and eliminating successive testing rounds. I’m a detailed oriented professional with a strong work ethic, sound problem-solving skills, excellent communication skills, self-organizing skills, Efficient, assertive and a committed team player

PROFESSIONAL EXPERTISE:

Business:

Understanding of clinical development and product commercialization processes.

Familiarity with FDA regulations such as 21 CFR Part 11 and GxP (GMP, GLP, and GCP).

Extensive knowledge and experience in all stages of the Software Development Life Cycle (SDLC) beginning from initiation, Validation and definition to deployment.

Experience in flowing relevant SOPs (Standard Operating Procedure) to support project validation effort.

Interpersonal:

Proactively identify roadblocks, and plan ahead to deliver on time.

Clearly communicate to all levels with ability to foster collaboration among cross functional teams.

Strong written and verbal communications skills, Ability to manage multiple tasks simultaneously. I am a self starter, but also be comfortable working in teams.

Strong technical skills and the ability to dig into technical issues.

Technical:

Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).

Skilled in preparing detailed Test/Validation Plan specifying the system’s inputs, outputs, limitations, entry and exit criteria etc. Define Test Strategy, create test plans and guide in test cases and scripts creation to ensure appropriate coverage for all projects

Participated in design reviews, software requirement review and generation, software testing and problem reporting and resolution associated with product software.

Experience Developing procedures for performing and documenting V&V testing.

Excellent at manual and some automated testing for client-server, Medical Products as well as web based applications. Expertise in writing positive and negative test cases.

Expertise in writing SQL queries and performing backend testing.

Well versed in conducting different kinds of tests such as functionality, positive, negative, smoke, integration, user acceptance, storage, performance, load and security, Backend testing and Regression Testing. Experience in white box as well as black box testing.

Highly motivated with strong QA skills, ability to interact with team members, developers, users and zeal to learn new technologies. Excellent organization and debug skills, Attention to detail

Well experienced in handling multiple projects same time and getting validation doc’s delivered.

Experience with the following: Strong manual data tester who can create test plans, test cases and an overall testing strategy and then create/execute reusable test scripts for software applications.

Computer Skills

Operating Systems: Win95/98, WinNT4.0 / Server, Win XP, Win2K Server, HP-UNIX

Databases: Oracle 7.X/8.0, MS Access-2000, MS SQL server 2000.

Packages: MS Office, MS Word, MS Excel, MS Project.

Testing Tools: Win Runner 7.2, some Load Runner, Rational, Visual Test and QTP (8.02 and 10.0)

Internet: HTML, IIS 4.0, VB Script, IE4.x and 5.5, Netscape 6

Defect tracking tool: Rational Clear Quest, Lotus notes and WRQ Reflection

Version Manager: PVCS Version Manager 7.5 and Microsoft Visio

Software Languages: C++ Programming, Assembly Language, Org Programming Language, ANSI C Programming, SQL, Power Script, Scheme, JAVA and XML.

GUI: Visual Basic 5.0/6.0, Developer 2000 (Forms 4.5), Crystal Reports 8, and Power Builder (5.0, 6.5, 7.0)

Professional Experience (Will Provide via email)

Education

University of Massachusetts June 1999

Bachelor of Sciences in Computer Science

Seeking career continuation in MS in computer science, with opportunities for professional advancement in proportion to achievement

Outstanding Performance Certification June 2008

PAREXEL Int. / Perceptive Informatics

Sybase Education and Certification: 1999

System and Database Administration ASE 12.0, Rapid Application Development Using PowerJ, Fast Track to JAVA, Using the Data Window Object PowerBuilder 7.0, Advanced PowerBuilder 7.0 Controls NGL, Fast Track to Replication Server Admin Adaptive Server Enterprise, Advanced Transact SQL, Fast Track to Adaptive Server Enterprise, Fast Track to PowerBuilder 7.0, EAServer 3.0 Administration, Building Applications Using JAVA and EAServer, Building WEB Applications Using EA Studio, ESD Professional Services QMS Fundamentals, QMS for Practice Managers

Work Status: US Citizen

References: Available upon request

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