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Validation Specialist Resume

NY

Summary:

  • 4+ years of diverse experience in Software Testing of Web based and Client/Server applications of Pharmaceutical Companies as a Validation Analyst and QA TESTER.
  • Hands on experience with all phases of Software Development Life Cycle (SDLC) and methodology.
  • Proficiency in Validation System Testing, Black box Testing, Functional Testing, User Acceptance Testing, Integration Testing ,Regression testing , Back End data base testing.
  • Experienced in writing the Test Plan, OQ (Operational qualification test cases) test scripts for Manual Testing, Functional, User Acceptance, integration testing and Regression testing.
  • Experienced in manual testing and Automation testing.
  • Experience in working with off-shore projects.
  • Good working knowledge of FDA Validation environment
  • Good knowledge of GXP (Good Clinical, Manufacturer Practice) Prescription Drug Marketing Act (PDMA), 21 CFR Part 11 Compliance regulations and Health Insurance Portability and Accountability Act (HIPAA). .
  • Experienced in writing Validation summary report.
  • Good documentation practice.
  • Good knowledge of SOPs
  • Expert in creating and managing the issue report for tracking.
  • Thorough when investigating and regressing bug.
  • Experience in writing SQL queries for testing.
  • Ability to interact with developers and regarding testing status and defect tracking.
  • Strong interpersonal and excellent written and verbal communication skills.

Technical Skills:
Testing Tools: Quick Test Pro-8.2, Win runner-7.0 , Load Runner.
Defect tracking tools: Test Director 8.0, Bugzilla
Operating Systems: Windows 95/98, 2000 Windows NT 4.0, Windows XP, VISTA
Languages: PL/SQL, C# (Basic), .NET (Basic),
Database: SQL Server, Oracle, MS Access
Knowledge: MS Office, Excel, word, Outlook

Employment History:
Confidential,NY
Title - Validation Specialist
05/08 – 11/08
Clinilabs is a contract research organization (CRO) that provides early phase and specialty clinical drug development services to industry. Our organization offers clients a turn-key solution for single center and multicenter Phase I and II Clinical trials. Clinilabs also offer specialty drug development services in a variety of therapeutic areas.
Clinilabs has worked for 9 of the top 20 pharma companies in the world, and 5 of the top ten CROs,
to conduct over 170 clinical trials and contribute to 9 successful new drug applications (NDAs).

Project Details -
Trial Perfect – Electrocardiogram (ECG) Management System – Web based system

  • ECG Management system will be used to collect and manage data which may be submitted to the food Drug Administration (FDA) to SUPPORT CLINILAB INVESTIGATIONS. The ECG management system will be used by the ECG Core Laboratory to manage ECG Data which is collected during the conduct of clinical Trials.

Responsibilities:

  • Test Plan creation.
  • Created OQ test scripts for the whole application.
  • Validated the system against the GCP (Good clinical practice) 21 CFR PART 11 compliance regulations
  • Performed User acceptance testing and Black box testing on the system.
  • Created Test Incident Report
  • Manage issue report and data base
  • Solved Software problems by addressing issues to off-shore development Team
  • Daily test progress report to management
  • Managed the test tracking spread sheet
  • Worked with project manager for Risk assessment
  • Followed sops for compliances and Validation of the system
  • Document validation efforts.
  • Followed SOPs to meet company’s standard

Sleep data application (SDA)
Sleep Data Application is the system running in the Clinilabs for Validation of STA file against the business rules configured as per the sponsor’s requirement. Generated the output file against the STA files.
Responsibilities:

  • Created Test cases to test the enhancement of the application
  • Configured the new Protocols in the SDA system as per final DTA (Data Transfer Agreement) in test environment
  • New Variable configuration in SDA as per DTA (Data Transfer Agreement)
  • Output files configuration and generation
  • Manual calculation of sleep data values as per definitions
  • Validation of business rules
  • Created Validation documentation of new protocols and changes
  • Prepared Change control documents.
  • Followed SOP for company standard

Environment: Manual Testing, SQL, .NET, Microsoft Excel and word

Secure Electronic data transfer (SEDT-V.2) – Web based System - User acceptance Testing

  • The SEDT system is developed to use to transfer Clinical Trials data (Sleeping disorder research) files quickly and security between clients work station and the host server. The SEDT system will encrypt files, transfer them via the internet and decrypt them once they have reached their destination server.

Responsibilities:

  • Analyzed comprehensive Functional requirement Specification (FRS) Specification (SDS).
  • Test plan and Test script creation. Test script execution.
  • Manual testing of the Admin Module, Data management coordinator Module and site user module for User acceptance testing.
  • Validated the system to see system is meeting the GCP (Good Clinical practice) and 21 CFR regulations
  • Bug logging and Tracking.
  • Regression testing
  • Managed the test tracking spread sheet and issue report.
  • Created traceability metrics
  • Tested Audit trail and E-Signature.
  • Coordination with developer and vendors regarding the testing issue.
  • Involved in weekly status meeting with Vendors and developers.
  • Coordination with end users, stake holders to enhance the requirements.
  • Documented validation efforts.

Confidential,NJ
Validation Analyst
05/06 – 03/08

  • J. Knipper and Company, Inc. have been dedicated to providing a broad array of healthcare marketing solutions, including comprehensive direct-mail, fulfillment, sampling, database, and sales force management. Knipper focus on developing a true partnership with their clients to meet their needs with outstanding care and personal attention.

Novo Nordisk HT Web Ordering System:

  • The application/system Novo Nordisk HT Web Ordering System is being developed to process orders for web ordering system for Novo Nordisk. The software will receive orders on a daily basis and submit valid orders to OMS

Sales Support System (S3)

  • J. Knipper and Company, Inc. intends to develop a web-based system named "Sales Support System" (S3) for supporting sales forces and various operations divisions at Knipper. S3 will integrate with various existing systems, and include the functionalities Data Entry and Order Management System with the incorporation of significant additional enhancements.

MySampleCloset.com (MSC)

  • MySampleCloset.com is a Web-based solution that allows physicians to order samples and literature in real time, allowing you to cover vacant or white-space territories efficiently. Transactions meet stringent regulatory standards for electronic signature, and offer real-time practitioner validation, and inventory and order confirmation. Knipper is able to offer MySampleCloset.com with client-specific branding.

Bay castle Data Save (Import and Export Utility):

  • The import and export utility tool “Data Slave” is developed like a framework and act like a generic tool where one could import predefined file & data formats and the data Slave utility is able to export to a desired file format or should be able to export the data to S3 database.

Responsibilities:

  • Validated the system to Make sure that system is meeting the requirement of GMP (Good manufacturing practice) PDMA (prescription drug marketing act) and 21 CFR Part 11 Compliance (Tested - Audit Trails and E Signature)
  • Extensively interacted with Developers and End users to analyze and verify business requirement.
  • Actively participated in team meetings to discuss the progress of testing.
  • Analyzed requirements (SRS) and developed detail test cases
  • Developed Test plan.
  • Ensured sample distribution system was compliant with PDMA regulations as well as 21 CFR Part 11 standards.
  • Developed detail Test Cases for Functional and Regression testing.
  • Updated the existing test Cases as per enhancements.
  • Executed Test Cases for the different modules of applications under test
  • Documented the Result.
  • Manually tested the functionalities of the application and validated against the requirements.
  • Involved in bug tracking and analysis of bugs.
  • Re testing the Bugs after Fixes to perform regression testing.
  • Verified and closed the bugs as per leads instruction.
  • Developed detailed reports of the bugs/Issue report.
  • Used Enterprise Manager for Back end testing, data manipulation using SQL queries in SQL Server

Environment: Manual Testing, .NET, Microsoft SQL Server 2000/20005, Microsoft Windows 2003 Professional, Bugzilla, Microsoft Excel
Education: Bachelor of Science

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