SUMMARY

• Over eight years of experience in information technology, including over five years in pharmaceutical industry with emphasis on Business Analysis, Testing, Technical Writing and Data Analysis.
• Extensive experience in creation & application of tools for information capture, management and analysis.
• This includes developing processes, templates, documentation as per business needs and regulatory requirements.
• Diverse experience in Validation Protocols, Quality Assurance, Computer Systems, Validation Documentation with profound knowledge of FDA 21 CFR Part 11 Rules.
• Extensive Experience in gathering, analyzing and documenting requirements.
• Experience in writing and creating Requirement Specifications, Requirement Traciability Matrix (RTM) and source to target mappings (STMs).
• Experience in Writing and executing the System, IQOQ and UATs in hp Quality Center .
• Experience in working closely with SMEs, BTQA, Technical Lead, Project managers, Developers, and Test Lead and different business leads to confirm & edit content required for inclusion in various technical documents.
• Excellent skills and knowledge on tools for Requirement Traceability and Version controls systems.
• In depth knowledge of the Systems Development Life Cycle (SDLC) models, such as Water Fall, Agile, and Spiral.
• Strong verbal and written skills for clearly delegating tasks to team members and for effectively communicating results to management.
• Excellent Experience in writing, storing and maintaining the various documents.
• Experience in giving training to customers regarding the software, on line and in person.
• Experience in writing the instructions about how to operate the software.
• Experience in taking meeting minutes, writing guidelines and producing status reports.
• Experience in using the ARC, CMDB
• Experience with using Share point, Gnosis, GDMS, Live Link and Source Forge for document repository purposes
• Involved in Validation Process and preparation of Validation Master Plan
• Experienced in writing Validation Protocols like IQ, OQ, PQ for Computer Systems Validation.
• Good Knowledge of Validation practices and cGCP, cGLP and cGMP.
• Good understanding of CAPA, SOP, change control records and review current operating procedures
• Good Knowledge of Relational databases, SQL queries and PL/SQL code.
• Knowledge of ICH guidelines and its regulatory requirements across the EU, Japan and US.
• Used TrackWise tool for quality management issues and tracking applications for Corrective and Preventive Action
• Strong experience in the creation and documentation of test plans and test cases with the existence of requirements and specifications

TECHNICAL SKILLS

Life Sciences: FDA Quality System Regulation, 21CFR Part 11(210/211), cGXP (cGMP, cGDP, cGLP), IQ, OQ, PQ, RTM, UR, FS, SOP’s, LIMS, Summary Reports, Audit TrailsLIMS & Data Management Watson, Track wise, SQL and Labware

Languages: C, C++, SQL, and VB6.0

Web Technology: Java Script, VB Script, XML, HTML

Databases: Oracle 8i, MS Access, SQL Server 2000

Operating Systems: Windows NT/95/98/2000 and UNIX

Testing Software: Quick Test Pro, Test Director, Mercury Quality Center 9.0

Other Tools: LC/MS, MS Office, MS FrontPage, MS Project

Others: Gnosis, Insight (Livelink), Source Forge, Share Point, GDMS

PROFESSIONAL EXPERIENCE

Confidential, CT

Business Analyst

Responsibilities:

• Created the requirements for the new features and enhancements.
• Organized the meetings between the users and developers to clarify the doubts and help speed up the process.
• Created the System and User Acceptance scripts in Hp Quality Center.
• Worked on creating IQOQ scripts in Hp Quality Center.
• Helped with Source to Target mapping required for next release.
• Helped with executing the System and IQOQ scripts for the previous release in Hp Quality Center.
• Created Project SDLC life cycle documents for Business and Stake holder Requirement Specifications, Solution requirement specifications for the SOCS - Pro project.
• Worked closely with SMEs, BTQA, Technical Lead, Developers, and Test Lead to confirm & edit content required for inclusion in various technical documents.

Confidential, CT

Data Analyst

Responsibilities:

• Sorting through the data from different databases to find out the information about the site status.
• Gathering and cleaning up the data and flag the site if there are any discrepancies.
• Communicate with the different groups to confirm the findings in databases.
• Creating a master inventory file of the sites with latest status updates and findings about site status to help closure of inactive sites so the billing can be stopped and company can save money.
• Conducting, attending and participating in various meetings to collect information.
• Using Service Center (CMDB), Viewpoint, Tririga, and Telebase databases for collecting data.
• Working in Access database to write queries to see data from different views to help with project.

Confidential, CT

Business Analyst

Responsibilities:

• Worked under aggressive timeline as a Business Analyst.
• Worked on the Source to Target mappings (STMs): Mapping the Ariba, Viper and Elara source systems attributes to target system attributes.
• Gathered the requirements for the project by coordinating with different teams and produce the requirement document.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Attend and contribute to weekly project status meetings, requirement reviews, Mapping sessions, Stage Gate (ELC process) meetings.
• Helping test lead by entering the requirements in the HP Quality Center.
• Guided team members about how to start with the ELC process & what documents are required to be completed for each phase.
• Using Share point, Gnosis for document repository purposes

Confidential, CT

Business Analyst/ Technical Writer

Responsibilities:

• Worked on the User Acceptance Testing Scripts for the QCS - Dry running and Writing the User Acceptance test scripts for the QCS project for all the three record types, LRD, LIR and Complaints.
• Generated, created and wrote the user requirements for all the three record types, LRD, LIR and Complaints by referring the workflows and field names.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Worked closely with Document Manager to submit ELC deliverables for digital signature using My Signature Book applications.
• Attend and contribute to weekly project status meetings, design reviews, Stage Gate (ELC process) meetings.
• Helped in creating CI entry in CMDB for the QCS project.
• Guided PM about how to start with the ELC process & how to engage different services required for project.
• Using Share point, Gnosis, Live Link for document repository purposes

Confidential, CT

Technical Writer

Responsibilities:

• Created and reviewed the Project iSLC life cycle documents - Project Plan, Program Plan, Requirement Specification, Design Specification, Architecture documents, Traceability Matrix, Deployment Plan
• Test case documents, Test plan and Test case Index & Result documents, Check point meetings and Agenda for the projects Enhance Capacity and Planning (eCPM 2.0), DIF new development - Candidate Reporting and Patient Centric View (PCV 1.2, 1.2.1, 1.3)
• Created and reviewed and uploaded for signatures, the PACC and ePACC iSLC documents - Change control form, PACC Plan, Test case document, Traceability Matrix
• Test case Index & Results (TCIR) document, Checkpoint meetings and Agenda for the Speed Goal Visualization (SGV 1.2.1), Clinical Reporting (ClinRep 3.0.5.6), Oracle Clinical Medical Dictionary Upgrade (MedDRA Version 10.1, 11.0 )
• Created and reviewed the ELC life cycle documents - Kick off meeting, Tailoring Form, Project Plan, Requirement Document, Design document
• Change control form, Bug Fix Plan, test case documents for Instrumenting the Business (ITB 1.1), Clinical Trial Relationship Management (CTRM).
• Worked closely with Business Analysts, Technical Lead, Developers, Modelers and Test Lead to confirm & edit content required for inclusion in various technical documents, including Data Migration Plan, Design Specification, Test Plan and Test Summary Report.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements. Worked closely with Document Manager to submit iSLC and ELC deliverables for digital signature using both USSI and My Signature Book applications.
• Attend and contribute to weekly project status meetings, design reviews, Stage Gate (ELC process) and Checkpoint (iSLC process) meetings. Produce and upload minutes into project folders in Gnosis for review by team members.
• Produce weekly status reports and upload them to Share Point for review by Technical Writing Lead and Program Delivery Manager.
• Completed the ARC 4.0 (Application Repository Core) training and helped updating the ARC entry as the data manager.
• Experience with using Share point, Gnosis, Live Link and Source Forge for document repository purposes
• Created the artifacts in the Source Forge (SF) for the related projects and also setup the working space in SF for different projects to keep the development work in it.
• Involved in assisting user with the User Acceptance Testing for the DAC (DIF Administration Console), captured the results and worked on the test document.

Confidential, MA

Technical Writer/Validation Specialist

Responsibilities:

• Created and reviewed as Quality and Compliance - Quality Control, Change Plan, Traceability Matrix, Requirements Specifications, Design/Configuration Specification
• Functional Verification and Installation Verification Test Scripts, Code Checklist, Unit Testing and Change Summary Report for Labware LIMS and Clinical Research Database (CRD) from Compliance and Quality perspective.
• Created Validation Lifecycle documents - Validation Plan, Requirements Specification, System Design Specification, Test Plan, Installation Qualification (IQ), Operational Qualification (OQ)
• Performance Qualification (PQ), Test Summary Report and Requirements Traceability for Waters Empower 2 (E2) Client/Server Chromatography Data Acquisition system (CDS).
• Involved in writing Validation Summary Report to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.
• Involved in assisting user with the User Acceptance Testing for Data Migration from CAVIAR to ORACLE Adverse Event Reporting System (AERS) in respect to Compliance, Quality and Validation.
• Created a spreadsheet for keeping track of pre-approved scripts, Executed scripts and post- approved scripts by Validation, Quality and Technical unit.
• Trained Users on Good Documentation Practices (GDP) and Good Testing Practices (GTP) SOP’s before the execution of User Acceptance Testing.
• Reviewed User Acceptance Test script for Data Migration from CAVIAR to ORACLE Adverse Event Reporting System (AERS) for SPRI Validation Unit (SVU)
• Generated Variances/Deviations for the testing effort and created Variance/Deviations log for specific projects.
• Involved in creating Statement of Work (SOW) and revision to the existing SOP’s.
• Interacted with developers to resolve technical issues and investigated the bugs in the application using Test Director.

Confidential, Littleton, MA

Technical Writer/ Tester/QA Analyst

Responsibilities:

• Worked extensively on various areas of the software - Helped improving the user interface and made it more user friendly.
• Designed the new software for the pre schools - Created requirement and design documents.
• Created the data base using Access and created the User Interface Forms using Visual basic.
• Created the database for all the new features added in the existing system.
• Gave online and in person training to the customers regarding software functionalities.
• Tested the functionality of new features - Responsible for performing User Acceptance Testing (UAT) for the application.
• Developed test plans, test strategies, test facility requirements, test scripts for validation testing.
• Reviewed and created Requirement Traceability Matrix (RTM) for the application.
• Integrated the Quick Books in the existing system.
• Designed and Created the Touch Screen/Lobby Interface for attendance, messaging and RSVP
• Designed and created the Cash Drawer and Receipt Printer applications for use with drop-in center service and point of sale management

Confidential

Quality Assurance Tester

Responsibilities:

• Analyzed specifications and developed Test Plan for the testing process of clinical trial data.
• Reviewed the applications specifications and scheduled the testing life cycle.
• Created the database (repository) using Test Director.
• Developed test requirements hierarchy using Test Director.
• Developed and executed manual system and UAT test cases.
• Prepared Test Summary Report.
• Investigated system faults and coordinated with developers to resolve technical issues.