SUMMARY

• Over 7 years of Industrial Experience in IT industry with 5 years in Computer system validation, 4 years in testing with strong background in performing Manual Testing and Automated Testing.
• Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulation.
• Good experience in writing Computer System Validation Plan (CSVP) and validation deliverables documents.
• Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like Waterfall, Spiral, V - Model and Iterative in relation to development and testing.
• Good knowledge of 21CFR Part 11 regulation and GxP’s (GMP, GLP and GCP) for Quality System Regulation (QSR).
• Through Experience in Prospective and Retrospective Validation.
• Comprehensive knowledge and extensive experience in writing and reviewing Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ. Developed Validation Summary Report.
• Maintained Requirement Traceability Matrix (RTM).
• Performed GAP analysis for identifying compliance gaps, developing corrective action plans, and implementing those corrective action plans.
• Good experience in writing Risk Assessment, Deviation report, Discrepancy report and User Acceptance Testing (UAT).
• Good experience with MS Visio in developing flow charts and flow diagrams.
• Experience in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations.
• Experience with Laboratory Information Management System (LIMS), Adverse Events Reporting Systems (AERS), Change Control Management System and Enterprise Document Management System (EDMS).
• Knowledge in performing Risk Analysis, Gap Analysis and preparing Remediation plans.
• Good experience in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Developed Test Summary Reports.Supported in performing UAT testing, Regression, integration and Black Box Testing.
• Reviewed and performed Corrective and Preventive Actions (CAPA’s).
• Experience in System testing, performed manual testing and automated testing. Used tools like Test Director. Proficient with Excel to manage different testing and data segregation activities.
• Knowledge of Mercury Quality Center which is a test management tool that organizes testing activities like Requirement coverage, Test case management, Test Execution Reporting, Defect Management and Test Automation, thus it gives centralized control over entire testing project.
• Experience in Quick Test Pro (QTP), WinRunner, LoadRunner.
• Good Knowledge of MS-Project which is an excellent tool for project executive in developing plans, assigning resources to tasks, tracking progress, managing budgets, analyzing workloads and scheduling project activities.

TECHNICAL SKILLS

Standards: 21 CFR Part 11, 820, GLP, GCP, GDP, GMP

Tool: Experience: MS Visio, Excel, Outlook Express, MS Word 2000 / XP, Power point, MS Office Suite, Star Office, Q-Pro, Agana, MS - Project, Citrix Database Application, Lingo, Expert Choice, Crystal Ball, Crystal Ball Predictor, Win runner, Load runner, Test Director.

Platform Experience: MS-DOS, MS Windows 95, Windows 98, Windows 2000 Professional, Windows XP Professional, Windows Vista.

PROFESSIONAL EXPERIENCE

Confidential, Collegeville, Pennsylvania

SQA / Validation Engineer

Responsibilities:

• Responsible for developing validation deliverables like Validation Plan, User Requirement, and Functional Requirement Specifications.
• Involved in documenting Vendor Assessment Report.
• Involved in developing Design Specifications (DS) document. Used MS Visio for pictorial representation of the Design Specifications.
• Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements. Responsible for documenting IQ/OQ/PQ protocols.
• Responsible for writing training manual and SOP’s.
• Responsible for ensuring documents are in compliance with GxP’s.
• Performed risk assessments. Reviewed and approved project deliverables.
• Developed test plans and test scripts for validation testing.
• Responsible for developing protocols for audit trail, time stamp and electronic signature for workflow of documents.
• Performed Load testing, blackbox testing and functionality testing for the entire application.
• Developed test cases and test scripts to perform regression testing.
• Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Involved with the development team to verify bug fixing and update bug report status using Test Director.
• Developed Validation Summary Report.
• Shared knowledge for promoting best practices to be followed by project teams.

Confidential, Lake County, IL

Validation Specialist

Responsibilities:

• Worked with team in generating and reviewing standards CSV deliverables documents in compliance with 21 CFR Part11.
• Responsible for Reviewing/Modifying User and Functional Requirements Specifications.
• Developed IQ/OQ protocols as per user requirement and functional requirement specifications (URS and FRS).
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deployment, training, document control in its Software Development Life Cycle (SDLC).
• Created flow charts in MS Visio. Assisted with Project Schedules and Task Lists. Used MS Project for scheduling and planning project activities.
• Involved in creating and maintaining Requirement Traceability Matrix (RTM) for the application.
• Used Documentum 4i for storing and maintaining the documents.
• Involved in preparation of Validation Strategy Documents.
• Responsible for writing Validation Summary Report to establish documented evidence that the system was validated.
• Developed test plans, test strategies, test scripts for testing. Used Test director for testing.
• Used Test Director as test management tool.
• Performed CAPA’s. Worked on Change Controls.
• Responsible for reviewing and executing PQ test scripts.
• Involved in System testing with the testing team, used QTP and test director.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Performed GAP analysis, Risk assessment and maintenance of hybrid systems, closed and open record systems.
• Developed training manuals for operating, auditing, and monitoring functions of the management system.

Confidential, Irvine, CA

Validation Engineer

Responsibilities:

• Involved in the qualification of Instron 5544 with Blue Hill software which is a force measuring instrument.
• Completed Vendor Training provided on Blue Hill Software which is used to operate Instron 5544.
• Initiated the draft of Validation Plan detailing the validation deliverables and responsibilities of the team members.
• Co-ordinated with the Developer to complete the draft of System Configuration Specification.
• Completed the Installation and Operational Qualification Protocols (IQ & OQ) to test all the Requirements and Configuration settings.
• Co-ordinated with Vendor for the execution of Vendor (IQ+OQ) protocols for Instron 5544. Routed the document for approval to Quality Assurance Representative.
• Involved in the execution of Teva IQ/OQ protocol to complete the GAPS in vendor protocol and documented the deviations.
• Involved in preparing the Performance Qualification (PQ) protocol and proctored the execution of PQ by the user.
• Co-ordinated the draft, review, and approval of Operational SOP and Administration SOP for Instron 5544.
• Prepared Requirements Traceability Matrix and Validation Summary Reports.
• Coordinated with Business Owner, Information Technology, Quality and Compliance, for the review/approval of all validation deliverables.
• Involved in the tracking, and recording of MS Excel Spreadsheets available on Teva’s network drives.
• Gathered information from owners of Spreadsheets belonging to various departments like QC, R&D, and Microbiology for their corresponding GxP relevance.
• Provided the information as collected from the User groups to Quality to identify the spreadsheets for GxP impact.
• Reviewed and completed training on the SOPs for ‘Spreadsheet Validation, use, and maintenance & Security.
• Reviewed the existing Validation Package of QC’s “Bleomycin Assay Spreadsheet” to identify the GAPs and the recommended retrospective validation for the Spreadsheet to meet current Teva Compliance standards.
• Involved in completing the GxP assessment and Preliminary Design Assessment for the Bleomycin Assay Spreadsheet by co-coordinating with Business Owner.
• Completed the draft of Validation deliverables like Validation Plan, Validation Protocols (IQ, OQ, PQ) based on the requirements, and Design Specifications and then finalized it by incorporating the comments provided by Business and Quality Representatives. Also, involved in routing these documents to Business Owners, Quality and Compliance team..
• Coordinated with Developer for the development of spreadsheet as per the Design, Requirements specified in SOP for validation of spreadsheets
• Involved in execution of Functional Testing Protocol (OQ) to test all the user requirements and design specifications.
• Maintained the Traceability Matrix. Prepared the Validation Summary Report androuted the document for approvals.
• Coordinated with Admin to release the Bleomycin Spreadsheet to PRODUCTION as specified in the Administration SOP.

Confidential, Bothell, WA

Validation Analyst / Technical Writer

Responsibilities:

• Ensured Data Migration compliance with LIMS
• Developed Standard Operating Procedure (SOP’s) for the company
• Documented Validation Plan, Test Cases and Test Procedures based on User, Business and Functional Requirements
• Designed and wrote training manual templates, design formatting, project planning and proofing documents.
• Conducted tests on technical features of LIMS and documented its usability.
• Wrote test specifications, testing methodologies and user manuals for LIMS.
• Designed and maintained Standard Operating Procedures (SOPs).
• Wrote documentation for computer System validation life cycle deliverables such as Validation Plan, Validation Protocols (IQ, OQ, PQ) and Validation Summary Report in accordance with FDA regulations.
• Developed and executed validation protocols for Watson’s LIMS.
• Monitored the testing conducted by testing team and documented the Validation Summary Report.
• Assisted the testing team, updated the Validation Protocols with the executed results and developed Summary Report.
• Coordinated with System Analyst, Project Manager, and Business Analyst to setup the pre-validation and Validation environment to execute the scripts.
• Made deviation investigations, SOP and quality system development, documentation control and equipment/facility qualification.
• Wrote the Scripts and analyzed these Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.

Environment: s: Watson’s LIMS, Oracle 9i, MS office 2004, MS Visio 2004