Sr Validation/QA Engineer

Jovita Gladys

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SUMMARY:

• 5+ years of experience in Computer System Validation (CSV) and Quality Assurance (QA).

• Sound knowledge of 21 CFR Part 11, 21 CFR Part 210/211, cGxP, and SDLC

• Created and reviewed Validation deliverables such as VSD, UFRS, RTM, and IQ/OQ/ PQ

• Performed Gap Analysis and wrote Remediation Plan for Legacy Systems.

• Experience in writing SOPs (Standard Operating Procedures).

• Sound Knowledge of CAPA, PM/CAL, and Environmental Monitoring System(s).

• Sound Knowledge of LIMS (LabWare) and Documentum.

• Performed manual and automated testing using Quick Test Pro (QTP), Win Runner and Test Director.

• Defect Tracking, Analysis, Management and Reporting using Quality Center and Test Director.

• Experience in Designing Test Plans, Test Scripts, and Test summary Reports.

• Testing experience includes GUI, Functional, Integration, System, Performance and Regression

• Excellent Team player with strong analytical, problem solving, interpersonal skills and quick learning abilities.

SKILLS:

QA Tools: WinRunner v6.0/7.0/7.6, TestDirector 6.0/7.2/7.8, Quality Center, Quick Test Pro (QTP), Rational Clear Quest.

Languages: C, C++, VC++, SQL, PL/SQL, HTML, Java1.2, Visual Basic 6.0.

Operating Systems: DOS, Windows NT 4.0 Workstation & Server, Windows 98/NT/2000/XP/2003 VMWare ESX Server 2.5.

Databases: MS Access 97/2000, SQL Server 2000/2005, Oracle 9i.

Reporting Tools: Crystal Reports (Business Objects XI)

EXPERIENCE

Allergen, Irvine CA Jan 2008 – present

Validation/QA Engineer

As a validation team member, was involved in Functional Verification (FV/OQ) and UAT (PQ) testing of LabWare LIMS system.

Responsibilities:

• Involved in the validated of LabWare LIMS. Responsible for writing validation deliverables such as IQ/OQ/PQ Test Plans, Test Cases and executing the IQ/OQ Test Cases for LabWare LIMS.

• Responsible for writing UAT/PQ test cases for LabWare LIMS.

• Responsible for writing test cases for the following LabWare LIMS modules: Lot Manager, Folder Manager, and Core Lab Workflow.

• Responsible for creating the static data (such as Product Spec, Product Grade, Item Code, Sample Plan, Sampling Point, Analysis, EM Program) prior to test case execution.

• Responsible for executing Test Scripts in accordance with Good Testing Practices and Good Documentation Practices.

• Executed test scripts based on test plan for system specific critical functions and deliverables. Documented the errors in accordance with Good Documentation Practices.

• Attended weekly status meetings with Project management on testing updates.

• Worked with Team Manager to track and coordinate validation activities.

Environment: LabWare LIMS v5.0 (Pharma Kit), Oracle 9i, MS Office 2003, MS Access 2003 and Windows 2000.

LifeNet, Virginia Beach, VA Nov 2006 – Dec 2007

Validation Analyst

As a member of the Validation Team, primarily responsible for reviewing validation deliverables such as VSD, UFRS, IQ/OQ/PQ Test Plan(s), RTM, Test Summary Report(s) and VSR in accordance with FDA regulations. Involved in the validation of Environmental Monitoring System (NovaTech LIMS) and CAPA (Corrective Action Preventive Action) System.

Responsibilities:

• Involved in preparing Validation Strategy Document (VSD).

• Reviewed User and Functional Requirement Specification (UFRS) and Requirements Traceability Matrix (RTM).

• Involved in preparing IQ/OQ/PQ Test Plan and Test Scripts.

• Wrote Test Scripts to carry out the Tests. Executed Test Scripts and documented the results in accordance with Good Documentation Practices.

• Developed procedural SOPs for VSD, UFRS, IQ/OQ/PQ Test Plan, IQ/OQ/PQ Summary Report, and VSR.

• Developing SOP based on system documentation for System Administration, Configuration Management, Performance Monitoring, System Use and User Training.

• Developed training documentation and was involved in training users on FDA Regulations, and 21 CFR Part 11.

• Performed QA review on various validation documents.

• Involved in the qualification process of Data Center and Network Infrastructure.

Proclinical Pharmaceutical Services Inc, PA Nov 2005 – Oct 2006

Validation/QA Engineer

As a member of the Validation Team, primarily responsible for preparing Validation Strategy Document, reviewing User and Functional Requirements Specification, Requirements Traceability Matrix, IO/OQ/PQ, Validation Summary Report, and documentation in accordance with FDA regulations. Involved in the validation of PM/CAL (Preventive Maintenance and Calibration) system

Responsibilities:

• Involved in preparing Validation Strategy Document (VSD).

• Documented all aspects of Systems Development Life Cycle in accordance with FDA regulations.

• Interacted with business users, reviewed and updated User and Functional Requirement Specification (UFRS) and Requirements Traceability Matrix (RTM).

• Involved in preparing Test Plans based on User and Functional Requirements Specifications (UFRS).

• Wrote Test Plan and Test Scripts to carry out the tests. Executed test scripts and documented the results in accordance with Good Documentation Practices.

• Reviewed and updated Installation, Operation and Performance Qualification (IQ, OQ & PQ) protocols. Provided guidance on protocol (IQ/OQ/PQ) development for the validation team.

• Responsible to define test Requirements, run and schedule automated tests, add and track defects using Quality Center.

• Developed and documented Test Summary reports for the tests undertaken.

• Reviewed and updates the SOPs for different parts of Validation.

• Developed System specific SOPs based on system documentation for Logical Security, System Administration, Change Control, Configuration Management, Performance Monitoring, Problem Reporting, System Use and Training.

• Involved in auditing the applications for compliance related to Electronic Signatures and Electronic Records for a closed System.

• Reviewed and documented Validation Summary Report.

• Responsible for maintaining validation documents.

Environment: LabWare LIMS v5.0, Oracle 8i, Quality Center, MS Office 2000, MS Access 2000 and Windows 2000.

Eisai Inc, Teaneck, NJ Aug 2004 – Oct 2005

Validation Analyst

As a team member, was involved in creating, reviewing and updating IQ/OQ/PQ Test Plan(s), Test Scripts, Test Summary Report(s), and RTM for the LabWare LIMS system.

Responsibilities:

• Wrote Documentation of Computer Validation Life Cycle, in accordance with FDA regulations including: Validation Plan, Installation Qualification (IQ) specification, Operational Qualification (OQ) specification and Performance Qualification (PQ) specification.

• Involved in the validated of LabWare LIMS. Involved in preparing and updating IQ/OQ/PQ Test Plans and Test Scripts.

• Responsible for writing test cases, and test scripts for the LabWare LIMS modules – Project Manager, Sample Manager, and Stability Manager.

• Responsible to define test Requirements, run manual and automated tests, add and track defects using Mercury Quality Center.

• Responsible for creating and executing Test Scripts in accordance with Good Testing Practices and Good Documentation Practices

• Developed Requirement Traceability Matrix to track requirements during the testing phase.

• Attended daily status meetings with Project management on testing updates.

• Involved in preparation of Validation Summary Report (VSR).

• Performed QA review on various validation documents. Worked with Validation Manager to track and coordinate revalidation activities.

Environment: LabWare LIMS v5.0, Oracle 8i, Quality Center, Quality Test, MS Office 2000, MS Access 2000 and Windows 2000.

Sovereign Bank, NJ Sep 2003 – Jul 2004

QA Tester

Worked as a QA Tester at Sovereign Bank, NJ. Involved in Automated Testing of an Online Banking Application, which provides online banking facilities to customers.

Responsibilities:

• Worked as an Automation QA Tester.

• Involved in testing on all stages of System Development Life Cycle.

• Involved in generating Test Plan and Test Specifications as per user’s Business requirements.

• Developed and executed Test scripts, and Test Cases.

• Performed Volume, Performance, Base line and multi-user tests using WinRunner.

• Regression testing was implemented at various phases of the development and test cycles using WinRunner.

• Reported and tracked testing progress in the customized bug tracking system

• Worked with developers to fix the problems.

Environment: HTML, Java Script, C++, WinRunner, LoadRunner, TestDirector and Oracle Server.

EDUCATION/CERTIFICATIONS:

Bachelor of Science in Information Technology from Mangalore University, India

Masters in Computer Application from Visveswaraya University, Belgaum, India

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