Professional Summary

• Over seven years of experience in Software Quality Assurance, Business Analysis, Validation and Testing providing a well-balanced understanding of business relationships, business requirements, and technical solutions.
• Analytical, methodical, and resourceful approach to problem solving, identifying and documenting root causes and corrective actions to meet short and long-term business and system requirements.
• Excellent hands-on experience in all phases of testing including Preparation of Test Plans, Reusable Test Strategies, Test Scripts, Traceability Matrix, and Test Summary Reports for executing test scripts according to SOPs.
• Good understanding of the System Development Life Cycle and Testing Methodologies.
• Experience in validation of Oracle Clinical, RDC, and TMS.
• Experience in creating the Validation Protocols (IQ, OQ, PQ), Test Plans, and Test Scripts.
• Experience in developing and reviewing User Requirements Specification (URS) and Functional Requirements Specification (FRS) documents.
• Good working experience in FDA regulated environment including 21CFR part11. Good working Knowledge of the GMP, GCP, GLP and GDP standards.
• Good user and validation experience in Trackwise 5.8.
• Managed meetings to review FDA validation protocols and procedures regarding 21 CFR part 11 guidance for the industry.
• Experience in tracking and resolving defects using Test Director by working closely with Developers throughout Software Defect Life Cycle.
• Developed quality control systems to ensure proper tracking of documentation in conjunction with FDA requirements.
• Worked closely with designers and developers in planning, scheduling, developing, and executing system level as well as integration tests for software application.
• Thorough Knowledge and experience of Microsoft Office tools like MS word, MS Excel, MS Access, MS Project and MS PowerPoint.

Technical skills

FDA Regulations / Validation Protocols:21CFR Part 11, 210/ 211, 810, 820, cGxP (cGMP, cGCP, cGLP), URS, FRS, RTM, IQ, OQ, PQ, SOPs, VSRs.

Clinical Applications:Oracle Clinical, RDC, TMS, FIREBIRD, Simple Forms

Operating Systems:IBM compatibles, MS NT 4.0, 95, 98,2000, Unix, Mac

Web Tools:HTML, XML, JavaScript, PL/SQL, TOAD

Testing Tools:Win Runner, Load Runner, Selenium, Quality Center

Tracking Tools:Test Track Pro, Bugzilla

Version Control/ Document Management:CVS, Alfresco, SharePoint

Education:

• Bachelor of Engineering – 2000 (Confidential University )

Professional Experience

Confidential. – San Mateo, CA (Feb 2006-Present)
QA/Validation Analyst

Responsibilities:

Worked on the following projects:

Simple Forms

Simple Forms provides an intuitive HTML interface for collecting data into Oracle Clinical directly from patients over the internet.

• Maintained, Reviewed and Updated documentation for Simple Forms up to version 2.3.8
• Wrote functional requirements, traceability matrix, test case objectives and test cases for each version of Simple Forms
• Performed Ad hoc testing on different functionalities of Simple Forms
• Created screen mock ups for different functionalities as per requirements
• Designed and developed validation protocols to ensure system performs as intended and according to design
• Created and maintained Oracle Clinical Study databases with relevant objects (dvgs, questions, question groups, dcms, dcis) to be used for Simple Forms testing
• Updated Oracle Clinical Study databases with new objects as per testing requirements
• Forms submitted using Simple Forms into Oracle Clinical were verified in Oracle Clinical
• Created Test Case setup data for Simple Forms QA/Validation run
• Lead Validation effort for Simple Forms
• Created Test Results Reports and Summaries for Validation run
• Created user guide for Simple Forms
• Interacted with stakeholders on a periodic basis during various stages of development and testing
• Wrote functional requirements, traceability matrix, test case objectives and test cases for browser compatibility of Simple Forms
• Cross browser testing of Simple Forms across IE, Firefox in windows and Opera on Mac
• Continues QA testing and validation work during different releases

DCI Copy

The DCI Copy utility is used to load Oracle Clinical CRFs from a CRF Copy XML Transport File into the local Oracle Clinical Installation

• Wrote traceability matrix, test case objectives and test cases for DCI Copy
• Interacted regularly with the development team during the life cycle
• Performed Ad hoc testing on different functionalities of the DCI Copy Utility

Dcapi Question Loader

• Performed Validation run on the Dcapi Question Loader Utility
• Created Test Results Reports for the Validation Run

OC Standardized Setup Objects

• Created OC Standardized objects that can be loaded into OC and used for QA/Validation run
• Created Standardized Validation objects that can be used for Simple Forms Validation

Bugzilla

• Created user accounts and managed user access to various products listed in Bugzilla
• Reconciled user accounts on a periodic basis

Oracle Life Sciences Products

BioPharm Systems provides hosting services for Oracle Life Science Products for various clients. The following are the ones that I had worked for.

• Performed OQ run on Oracle Clinical 4.5.2 for (Radiant Research)
• Reviewed documents for the RDC and TMS test suites (MDS Pharma)
• Performed OQ on Oracle AERS (Radiant Research)
• Performed IQ during their upgrade to 4.5.3 on Oracle Clinical and RDC (Dendreon)
• Incident Reports were logged with the client (Dendreon)
• Performed IQ on OC/RDC 4.5.3 and TMS 4.6 (SDC Clinical)
• Performed IQ on OC/RDC 4.5.3 and TMS 4.5.2 (Dendreon, Hana Bioscience, Xenoport)
• Incident Reports were logged with the client (Dendreon, Hana Bioscience, Xenoport)
• Was part of the team that worked on implementing SDTM data model in Oracle Clinical (Johnson & Johnson)
• Performed IQ for OC 4.5.3, RDC4.5.3 and TMS4.6 (Covidien)
• Performed QC on the Oracle Clinical v4.5.3 Validation Suite (BioPharm Systems)
• Executed patch regression test suite for OC and RDC 4.5.3.12 (BioPharm Systems)
• Performed IQ for OC and RDC following the Production Patch 11&12 Application and iAS Report Server Upgrade (Xenoport)

Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD)

Firebird is a software application that supports electronic submission of clinical trial investigator information to trial sponsors and regulatory bodies.

• Created test cases for the entire application consisting of 12 modules
• Interfaced with multiple teams during development and testing cycles
• Performed QA testing for various releases of the application
• Bugs found were reported and tracked using test track pro
• Continued testing and bug reporting on new releases of application
• Created Test Execution Logs and Screenshot Templates

Environment: Oracle Clinical, RDC, TMS, Windows 2000/NT, UNIX, Mac, SQL*Plus, TOAD, JavaScript, Test Track Pro, Bugzilla, SharePoint, Alfresco, Quality Center, CVS, MS Word, Simple Forms, 21 CFR Part 11, FIREBIRD.

Confidential, Marlborough, MA (Nov 2004-Dec 2005) 
Validation Analyst

Responsibilities

• Worked on the validation of Labware LIMS and performed testing on the instruments for data acquisition and data management.
• Liaison between the business needs (business users and sponsor) and the technical solutions (development and testing staff), ensuring technical solutions satisfied business requirements and resolve issues.
• Wrote documentation for validation in accordance with FDA regulation particularly 21 CFR part11 validation plan and protocol.
• Interacted with developers and end users to gather requirements.
• Involved in authoring Business and Functional Requirements with supporting diagram use cases, traceability matrices, and training manuals.
• Involved in technical writing of SOPs and maintained requirements traceability matrix.
• Evaluate change request and conduct impact assessment.
• Used the audit trail mechanism to monitor all activities and data transactions and storing these activities.
• Performed vendor audits, laboratory audits and general cGMP compliance audits.
• Analyzed test scripts to verify the functionality in compliance with 21 CFR part 11.
• Involved in the review and design of test cases, process change requests, analyze and map process.
• Used querying tools like TOAD to test certain data in the interface tables.
• Attended training sessions on GDPs (Good Documentation Practices) that have to be followed as a part rigorous System & Integration Testing.
• Involved in writing IQ/OQ Test Plan, Scripts & Summary Report for Test as well as in Production environments.
• Assisted in developing the Validation Plan and Final Summary Reports.

Validation Analyst/Technical writer

Responsibilities

• As a Validation Analyst, I was involved in Business Analysis and validation of Documentum Enterprise Content Management (ECM).
• Liaison between the business needs and the technical solutions (development staff), ensuring technical solutions satisfied business requirements.
• Was involved in authoring business and system requirements analyses and functional specifications with supporting business process flows (data modeling), traceability matrices, risk analyses, utilizing FDA standards, processes, and procedures. Developed detailed front-end prototype utilizing DreamWeaver.
• Worked with system users to interpret and document business use of the system, and reviewed the User Requirements and Functional Specification documents for the applications.
• Developed the Detail Design Specification documentation in collaboration with the development team.
• Developed the qualification protocols (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)). Performed Manual and Automated testing.
• Coordinated and developed the Qualification Test Plan, incorporating inputs, workload, and responsibilities of all qualification participants.
• Used Trackwise v 6.0 to log and track system deviations and compliance issues.
• Used Trackwise for change initiation requests.
• Interact with project team members to manage and track projects from inception all the way to delivery.
• Involved in developing the Validation Plans for the applications.
• Developed and maintained test strategies.
• Performed Functionality, System testing and regression testing according to the SOPs and departmental guidelines.
• Prepared and updated the Test Plans, Test Scripts and Traceability Matrix as the requirements were updated.

Environment: Windows 2000/NT, UNIX, SQL*Plus, TOAD, Documentum, Trackwise, MS Word, 21CFR Part11.

Validation Analyst/Technical writer

Responsibilities

• Was involved in the computer system validation to develop IQ, OQ, PQ specifications for a new Labware LIMS system.
• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21, Part 11.
• Developed business requirements for Access-based document tracking application. Wrote and edited requirements, test cases, and traceability matrices for upgrades and new releases.
• Involved in creating the Validation plans for the applications.
• Involved in validation of Sparta systems Trackwise v 5.8for 21cfrpart11 compliance, change control, audit and CAPA.
• Verified OQ, PQ scripts for Sparta systems Trackwise application and made changes where needed.
• Involved in the review and design of test cases, process change requests, and analyze and map process.
• Maintained requirements tractability matrix.
• Involved in technical writing of Standard Operation Procedures, Functional
• Requirement Specifications.
• Interface with internal Departments like Quality, Project Engineering, Production, and other end users to understand and write User Requirements, Functional Requirements, and Detailed Design Specifications for the software systems.
• Carried out System Testing, Functional Testing, Integration Testing, Regression Testing and Performance Testing according to the SOPs and departmental guidelines.
• Generated, enhanced the Users scripts and scenarios using Load Runner.
• Analyze the Discrepancies, severity, tracking system and reporting through Test Director.
• Writing and execution of test plans, test cases based on requirements of the application.

Environment: Windows 2000/NT, UNIX, SQL*Plus, TOAD, Labware LIMS, Trackwise, MS Word, 21 CFR Part 11.

Validation Analyst

Responsibilities

• Involved in Remediation compliance validation of Legacysystemand Retirement Process Plan.
• Created Inventory list of systems that needs assessment.
• Conducted interviews with System Owners to ensure the validity of the systems.
• Assisted with business case high-level feasibility, gather and define business requirements and analyze and map process, analyze data.
• Process change requests and trace requirements during implementation.
• Performed System validation before the commencement of the Validation process.
• Generate remediation plan to cure the system(provided requirement, H/W, S/W, SOPs, 21 CFRpart11 criteria, interface information).
• Worked on 21 CFR Part 11 assessment and GMP assessment to find the compliance gaps in the system.
• Liaised with other project areas to coordinate interdependencies and resolve issues.
• Create Assessment Summary report to detail the gaps of the system.
• Involved in creating Remediation Plan for many systems to resolve the Compliance gaps.
• Worked with System Owners to discuss the Remediation plan, the schedule and Budget involved in Validation.
• Clearly identified closed and open systems according to 21CFR Part 11.10 and 11.30.
• Checked whether the execution of the e-signs are Audit trailed
• Used authority checks to ensure that authorized individuals can enter sign or change data. Audit Trails, preparation of Traceability matrix.
• Tested for signature manifestations in compliance with 21 CFR Part 11

Environment: Windows 2000/NT, UNIX, MS Word, 21 CFR Part 11, GxP.

Technical writer

Responsibilities

• Worked on validating MRP software for inventory control and manufacturing process.
• Was involved in writing Validation Plan, Validation protocols according to the functional requirements.
• Involved in develop Requirements Traceability Matrix (RTM) to cross reference functional requirements and IQ, OQ test scripts.
• Involved in developing Software IQ/ OQ and Infrastructure IQ/ OQ documents.
• Developed Software IQ and Hardware IQ and verified whether they meet manufacturer’s recommendations.
• Ensured OQ tests the functionality of the Software including Alarm and Event tests.
• Involved in the review and design of test cases, process change requests, analyze and map process.
• Assured Software Validation in compliance with cGMP regulations.
• Analyzed validation protocols for 21 CFR Part 11 compliance.

Environment: Windows 2000/NT, UNIX, SQL*Plus, MS Word, 21 CFR Part 11.