SUMMARY:

• Overall 7+ years of experience inValidationwith strong background in Computer SystemValidation, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part … compliance and GAMP, GxP's (GMP, GLP and GCP).
• Excellent experience in theValidationof highly regulated enterprise level business systems Siebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS), Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy.
• Good understanding of CMM and CMMI model approaches
• Working experience of cGMP and GLP environment to care for thee validation.
• Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
• Expertise in creating and executing Computer SystemValidationPlans, SOP's, protocols and Validationtest scripts and document test results in accordance with FDA standards.
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations.
• Good working knowledge of Quality Management Systems (QMS) like Remedy and TrackWise.
• Developed and reviewed Test Plans,Validationprotocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Experience in using quality center to manage testing artifacts.
• Performed GAP analysis in identifying compliance gaps.
• Developed and implemented corrective action and preventive action plans (CAPA).
• Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Performed various types of testing like Black box, Performance and UAT testing.
• Expertise in writing and reviewing theValidationdeliverables.
• Very proficient in writingValidationSummary Report (VSR) and Test Summary Report (TSR).
• Excellent verbal, documentation and organizational skills.
• Strong hands on experience in using Win Runner, Load Runner and Test director.
• Ability to work both independently and in a team-oriented working environment.

WORK EXPERIENCE:

Confidential, IN

Validation Test Engineer

Responsibilities:

• Responsible for writingValidationPlan.
• Used Lab ware LIMS application which has modules like sample testing, assigning new tests, entering results and reviewing result data.
• Tested the above applications on SOA: Soap UI, Soap/Restful Web services, windows, client/server, web based and UNIX environments.
• Tested the Provisioning system -" Service Profile Inventory Manager (SPIM)" and the Inventory system - "Configuration Management Data Base (CMDB)" using API web service testing through usage of SOA: Soap UI, Soap/Restful Web services
• Used MS Visio to document workflow and flow diagrams for design business process. Used MS Project for planning and scheduling project activities.
• Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Implemented FDA Quality System Regulations such as Design Verification, and proper actualization of design and safety standards required to meet FDA CGMP qualifications
• Updated the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules.
• Involved in project Management and Team building activities e.g. taking minutes of meeting and following up with team members to get the job done as discussed on time and scheduling other meeting as per project needs.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• RetrospectiveValidationof Trial Finder. Involved in performing the GAP Analysis of the system.
• Developed Risk Assessment and Deviation Report.
• Responsible for managing documents in the corporate document management system.
• Responsible for documentation of all aspects of the Computer SystemValidationLife Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
• Responsible for creating test cases for Installation and Operational Qualification (IQ/OQ) of the application.

Tools: HTML, XML, JavaScript, PL/SQL, TOAD, Win Runner, Load Runner, Selenium, Quality Center

Validation Consultant

Confidential, Rochester, MN

Responsibilities:

• Developed the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document.
• Used extensively Web Services and XML/XSLT technologies for data exchange operations.
• Developed installation and operational protocols and SOPs for computerized pharmaceutical/ biotech/
• Medical device/ diagnostic processes per cGMP/ GAMP standards and perform IQ/ OQ executions.
• Performed internal audits (FDA cGMP and 21 CFR Part 11 Compliance) for Global Technical Services on Computer Validation. d internal SOPs for Systems Validation, cGMP, and 21 CFR Part 11 Electronic Signatures compliance in FDA regulated environment.
• Performed User Acceptance Testing in compliance with cGMP and GDP requirements.
• Developed theValidationPlan (VP) for SAP implementation by following the corporate guidelines.
• Collected User Requirements (URS) for TrackWise by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements.
• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.
• Provided TrackWise implementation consultation and conduct Functional and technical review sessions.
• Managed and guided project team to implement TrackWise EQMS projects.
• Lead requirement gathering workshops with business team to extract and record user requirement specification and model workflows.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing.
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.

Tools: QuickTest Pro, LoadRunner, Test Director, Visual Source Safe, Visual Intercept, Clear Quest, PVCS Tracker

Validation Analyst

Confidential, Annandale, NJ

Responsibilities:

• Analyzed user requirements document, system specification document.
• Developed, implemented and executed test methodologies and plans to ensure software product quality.
• Performed inspection method development, programming, qualification, and documentation for Smartscope and Zeiss Optical CMM systems.
• Advise on quality control to Senior Management in order to monitor and recommend on FDA cGMP compliance of batch records, manufacturing records and finished product approval.
• Created test plan and detailed test cases using Quality center.
• Tracked changes made to the requirements, tests and defects using Quality center.
• Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements.
• Worked on Traceability Matrix
• Created and reviewed IQ, OQ, PQ protocols, MasterValidationPlan.
• Automated Test scenarios for GUI, Functionality, Boundary, Security and Regression Testing.
• Performed Data Migration Policy.
• Coordinate the activities in the SDLC with focus on the system analysis and maintenance activities.
• Technical involvement with projects, support during audits, and collaboration with the vendors.
• Wrote and executed test cases to validate user requirements and exercise all system functions
• Provided aValidationstrategy documents which involved project overview, development approach, roles and responsibilities,Validationapproach and deliverables.

Testing Tools: Win Runner, Load Runner, QTP, Mercury Quality CenterOther Tools MS Visio, LIMS LabWare LIMS, LabVantage LIMS

Quality Analyst

Confidential, Pittsboro, NC

Responsibilities:

• Worked on oracle AERS to capture all clinical trials.
• Worked on NTX Wireless Patient Monitoring System and generated its Adverse Event report.
• Responsible for developing standard documents forValidationdeliverables likeValidationPlan, 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.
• Wrote manual and SOP's.
• Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Documented IQ/OQ/PQ protocols.
• Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements.
• Developed test plans and test scripts for Validation testing.
• Developed protocols for audit trail, time stamp and electronic signature for workflow of documents.
• Performed Black box testing, Load testing, and functionality testing for the entire application.
• Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved.
• Developed test cases and test scripts to perform regression testing.
• Performed User Acceptance Testing (UAT) for the application.
• Involved with the development team to verify bugs and updated bug report status using Test Director.
• DevelopedValidationSummary Report.

Tools: HP Quality Center 10, Test Tracker, Crimson Editor, Sante DICOM Editor & Viewer, SQL+, Altova XMLSpy

Validation Analyst

Confidential, Basking ridge, NJ

Responsibilities:

• Created Validation Plan, Design Specification, User Requirements Specifications, Test Plan, System & UAT Test Scripts, Requirements Traceability Matrix, Test Summary Report,ValidationSummary Report.
• Performed Quality Assurance responsibilities by reviewingValidationdeliverables for various projects for compliance with SDLC, CSV, 21 CFR Part 11 requirements and GxP regulations.
• Validated Standard Operating Procedures to ensure compliance with FDA regulations and 21 CFR Part 11 requirements.
• Developed Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases.
• Provided guidance on CSV, Computer System Regulatory Assessment and SDLC Risk Assessment.
• Developed test scenario(s) to test each Functional Requirement.
• Developed and reviewed IQ/OQ/PQ protocols.
• Involved in creating, reviewing and editing new and revised SOPs and Work Instructions.