Professional Summary:

• Over 6years of diversified experience in Validation Methodologies, Technical Writing and Quality Assurance in Pharmaceutical Industry with a strong background in performing Computer System Validation and Software Development.
• Experience with entire life cycle of Computer Systems Validation including User Requirements Specifications URS , Functional Requirements Specifications FRS Vendor Assessment VA and System Design Specifications SDS .
• Experience in developing protocols, Executing tests and Constructing Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies
• DocumentedData Migration Plan and Back-up and Recovery Plan.
• Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Front end Testing and also automated testing tools like HP Quality Center.
• Experience in Validation Procedures, technical writing for systems in compliance withcGMP, GAMP, cGLP, and cGCPs, as well as Sarbanes-Oxley, HIPAA, and privacy regulations.
• Experience in writing and reviewing Computer System Validation Plan/Remediation.
• Extensive experience in writing and reviewing Standard Operating Procedures SOPs , Work Instructions WIs , Requirement Traceability Matrix RTM and Validation Summary Report VSR .
• Experience in writing Risk Analysis, Gap Analysis, and CAPA documents
• Developed comprehensive Test Summary Report and Test Cases
• Extensive Experience in Enterprise Document Management System EDMS with automated systems such as Documentum and GXPharma.
• In depth knowledge of FDA regulations 21 CFR Part 11 Electronic Records and Electronic Signatures, Audit Trails and Security events .
• ExtensiveExperience in working with MS Visio, PowerPoint, Word and Excel.
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.

TECHNICAL EXPERIENCE:

• Validation: IQ/OQ/PQ Protocols, FDA Regulations, 21 CFR part 11, GAP Analysis, GxP cGMP, GCP, GLP, GDP Environments, VMP, RTM, SOP, Audit Trails.
• Operating System: WIN NT/2000/XP/7, Mac OS 9, Mac OS X
• Tools: MS Visio, MS Project, Documentum, Mercury Win Runner/ Load Runner,TOAD
• Databases: MS SQL, MS Excel, Oracle

WORK EXPERIENCE

Confidential

Business Analyst

Responsibilities:

• UsingMS Visio to document workflow and flow diagrams for design business process. Used MS Project for planning and scheduling project activities.
• DevelopingFRS Functional Requirements Specification and DS Design Specification from the URS User Requirement Specification for system application development.
• Documenting IQ, OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Documenting the Data Migration Plan for the Data Migration.
• Updating the Requirement Traceability Matrix RTM upon completion of Functional Verification and User Acceptance Test execution and mapping the RTM to the Functional Specification, Design Specification and User Requirement Specification.
• Analyzing Test scripts and mapping it to the URS to check functionalities covered.
• Involved in performing the GAP Analysis, Root Cause Analysis of the system and develop Remediation Plan.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.
• Involved in all the phases of Software Development Life Cycle SDLC methodologies throughout the project life cycle
• Responsible for managing documents in the corporate document management system
• Coordinated between various teams to insure consistency and accuracy across test plans, user manuals and training materials.

Environment: Agile, Share Point, MS Visio, Windows 7, SnagIt, Microsoft Office Suite Word, Excel, Power point, Access

Confidential

QA Test Lead

Responsibilities:

• Used MS Visio to document workflow and flow diagrams for design business process. Used MS Project for planning and scheduling project activities.
• Involved in gathering the User Requirements from the System Owners document for all the software components.
• Developed FRS Functional Requirements Specification and DS Design Specification from the URS User Requirement Specification
• Documenting IQ, OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Used HP Quality Center for bug tracking, reporting and following up with development team
• Updated the Requirement Traceability Matrix RTM upon completion of Functional Verification and User Acceptance Test execution
• Interacted with Subject Matter Experts SME to understand and document the workflow and functionalities on different modules.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Involved in performing the GAP Analysis, Root Cause Analysis of the system and develop Remediation Plan
• Responsible for managing documents in the corporate document management system.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.

Environment: Agile, Share Point, MS Visio, Windows 7, SnagIt,TOAD

Confidential

Analyst/QA Tester

Responsibilities:

• Used RAD methodology and consulted the ITQ, QA, Business Owners for planning the different phases of the project.
• Reviewed and modified existing Standard Operating Systems SOPs for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.
• Worked on change control documentation such as Change Request Form CRF's , Change Control Implementation Plan, Change Control Summary Report.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Documented Installation Qualification IQ , Operational Qualifications OQ , and Performance Qualifications PQ documents using standard templates.
• Written and reviewed Requirement Traceability Matrix RTM .
• Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using Test Director and paper based manual testing.
• Expert level knowledge in reviewing and modifying standard operating procedures SOP .

Environment:Waterfall , Share Point, MS Visio, Windows 7, SnagIt, Load runner, HPQC

Confidential

Validation Engineer / Tester

Responsibilities:

• Written User Requirements specifications, Functional Requirements specifications document, Design Specification document in compliance with 21 CFR PART 11 Requirements.
• Designed architectural diagrams, process map/workflow and entity relation maps of the documents or process using MS Visio
• Responsible for developing Validation Plan
• Responsible for writing and executing Installation qualification IQ , Operational Qualification OQ and Performance Qualification PQ protocols to check installation and successful operation of the application.
• Writing test scripts for all the deliverables
• Performed front end testing, positive and negative testing, GUI testing, and regression testing
• Performed GAP Analysis and prepared Remediation Plans.
• Conducted reporting and tracking of defects using Quality Center.
• Utilized Document and created documentation in all phases of the SDLC
• Performed Risk analysis
• Created and maintained the Requirement Traceability Matrix RTM for the application.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Responsible for developing the Data Migration Plan.
• Involved in creating System operational and Administration SOP's.
• Executed test cases based on the test plan and in accordance with Good Documentation Practices GDP
• Responsible for reviewing and executing IQ/OQ/PQtest scripts.
• Responsible for performing User Acceptance Testing UAT for the application.
• Developed User manuals and Training manuals.

Environment: Waterfall, Oracle , Share Point, MS Visio, Windows 7, SnagIt, SQL,HPQC

Confidential

Engineer/Tester

Responsibilities:

• Involved in gathering the User Requirements from the System Owners document for all the software components.
• Developed FRS Functional Requirements Specification and DS Design Specification from the URS User Requirement Specification
• Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Actively involved with the application developers in developing the high level System Design Specifications SDS documents.
• Used MS Visio for pictorial representation of the Design Specifications and workflow of the process.
• Involved in documenting Vendor Assessment Report from a list of AERS suppliers.
• Developed Requirements Traceability Matrix RTM to track requirements during the QA Testing Phase.
• Checked the modules of the application and used SQL queries to extract the data from database.
• Involved with the development team to verify bug fixing and update bug report status using HP Quality Center.
• Responsible for writing change controlSOP's to comply with 21 CFR Part 11 requirements.
• Developed test plans, test strategies, test scripts for validation testing.
• Responsible for developing test protocols for audit trail, time stamp and electronic signature for the work flow of documents
• Prepared training documentation for the various SOP training.
• Involved in writing audit plans for the quality department
• Expertise in audits and assessments on documents and systems.

Environment: Waterfall, Oracle , Share Point, MS Visio, Windows 7, SnagIt, SQL,HPQC,TOAD