SUMMARY

• Having 13+ of experience in Quality Assurance and Computer system Validation and working as a ‘Computer System Validation Lead’ in ‘ Confidential Technology’.
• Overall 11+ years of experience in Life Sciences domain and Over 1+ years of experience in Airlines and Travel domains
• Having 8+ years’ experience on Computer System Validation process on life sciences systems/applications and worked for Arthrex, Confidential, IDEXX Laboratories clients and successfully lead team in the Validation projects
• Hands on experience on Life sciences Computer System Validation, Risk Based Validation Approach based on GAMP 5 guidelines in the process scope determination for validation and involved Corrective and Preventive Action process (CAPA)
• Having experience on Medical device manufacturing applications, Patient Management Systems, Clinical Trial Management Systems, Cell therapy and digital lab experience in DICOM, Digital Radiography, Computed Radiography scanners
• Performed GxP (GCP, GMP) Verification and Validation on Clinical Trial Management and Medical device manufacturing applications/systems/software, COTS, cloud based (Saas) applications and responsible for ensuring accuracy, completeness and compliance of software deliverable in regulated industry.
• Experience on creation of Validation Master Plan, strategies, Traceability matrix and Validation Summary Reports and metrics
• Experience on creation/Identification of IQ, OQ and PQ protocols based on FDA/MHRA regulatory and compliance standards (21 CFR Part 11 and 21 CFR Part 820, EU Annexure 11 regulations) and scope of changes. Validating the protocols and ensure the intended behavior of systems and maintain the protocol documents with all approvals
• Having experience on functional, Integration, regression, compatibility testing and involves UAT, SAT on various client/server and web - based, .Net, Mainframe and desktop software applications at different stages of SDLC and STLC
• Having experience directly working with stakeholder, business analysts and project management team and worked as SME for few projects and identified gaps in the function flows and involved in the creating the user requirement and functional requirements.
• Create and revise validation test practices, Standard Operation Producers (SOP’s) and other documentation to support the COE and end users
• Performed database testing and validated the migration of data into production environment and having experience on developing the SQL queries using Oracle SQL developer tool.
• Experience on Databases Migration qualification using Qualitative and Quantitative protocols
• Hands on experience on various project and Validation/testing/defect management tools (HP QC, ALM, JIRA, Bugzilla, ServiceNow, FootPrints)
• Hands on experience on document management systems (SharePoint, Documentum and Visual Source safe) and MS office tools
• Having experience on ‘Agile Scrum’, V-Model and waterfall Methodologies’.
• Experience in creating Test plan, Test Strategy and Test Specification document.
• Knowledge on ASTM-E2500 validation strategy and ICH Q8,Q9,Q10 guidelines
• Knowledge on Veeva Vault (eTMF, Quality Documents)
• Excellent knowledge and experience in capturing various Test Metrics in all phases of testing, created many templates to derive metrics
• Knowledge on the automation testing using tools QTP (UFT) and Selenium
• Knowledge on Business Process Testing (BPT) automation framework.
• Knowledge on Python language
• Good Communication, interpersonal skills, Commitment, result oriented, hard working with a quest and zeal to learn new technologies and undertake challenging tasks.

TECHNICAL SKILLS

• Computer System Validation
• Manual/Functions testing
• Database Testing,
• Functionality, System, Regression and Automation Testing.
• Solidworks 2018/2019
• SQL
• Python
• SharePoint
• HP ALM, JIRA
• ServiceNow
• Oracle Agile PLM
• PODSS (Precision Oncology Decision Supporting System)
• Confidential (Quantitative imaging Analysis Core)
• PDOL (Protocol Document Online),
• IACUC (Institutional Animal Care Use Committee),
• CRC (Clinical Research Committee)
• IRB (Institutional Review Board)
• IBC (Institution Biosafety Committee)
• MTA (Material Transfer Agreement)
• MRM-DAM (Marketing Resource Management-Digital Asset Management)
• CPDC (CNC Machines Program Delivery Unit)
• PACS (Picture Archiving and Communication System)
• Cornerstone
• MARS (Mobile Ambulatory Reordering Systems)
• Minitab
• Documentum
• Success Factors - LMS (Learning Management System)
• ServiceNow

PROFESSIONAL EXPERIENCE

Confidential

QA Analyst

Responsibilities:

• Work with Business Analysts, End Users and Developers to understand User Requirement Specifications and scope of changes
• Analyse the requirements and identify the scope for Validation Testing based on risk-based approach and prepare categorize the requirements and document then
• Perform requirement ambiguity testing to identify the gaps in the requirements in each release
• Involve in preparation of Design Qualification (DQ) documents which is documented based on User Requirement Specifications
• Prepare Validation Plan for each Qualification process and IOPQ document based on category of application
• Lead the team and provide guidance on current project activities.
• Assign the tasks to the team and review the tasks of the team
• Author or identify Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for MRM, DAM, Agile PLM software’s
• Perform Computer System Validation using Operational Qualification (OQ) and Performance Qualification(PQ) protocols on MRM(Aprimo), DAM, Documentum, Success Factor-LMS, and Oracle Agile PLM software’s, Minitab, CPDU which are used in medical device manufacturing & management process based on FDA 21 CFR Part 11, 21 CFR Part 211.68, 21 CFR Part 820 Compliances
• Prioritize the test protocols to be executed based on the requirements severity and defect fixes.
• Create Custom tool, Hardware and Inspection Gauge models, prototype using Solidworks and validating the integration between Agile PLM
• Log and track the defects and screenshots in HP ALM 12.55
• Perform defect validation on resolved defect and perform regression testing accordingly
• Verify and Validate the software based on corrective and preventive actions in the CAPA process
• Perform Database and Migration qualification on Agile PLM after migrating project legacy data into production database. Using Qualitative and Quantitative protocols
• Perform the browser compatibility testing on MRM-DAM applications
• Create validation summary reports for each release and route the document for approval and maintain the revision history.
• Attend scrum calls, Defect Triage meetings with developers and BA team

Environment: Oracle 18c, SQL Server 2012 and 2018, Citrix, MQ1, SharePoint, Microsoft SQL developer, HP ALM 12.55 with VERA software, BMC-FootPrints 12.1, Workfront Windows 7 and 10 OS.

Confidential

QA Analyst

Responsibilities:

• Understanding the MD Anderson business flow based on User Stories and flow diagrams provided by client
• Analyse the requirements and identify the scope of changes based on risk-based approach and prepare impact assessment documents
• Involve in preparation of System Design Specification (SDS) and Design Qualification documents which is documented based on User Requirement Specifications and configuration changes.
• Prepare Validation Plan and strategy to define the process of validation
• Lead the team and provide guidance on current project activities.
• Assign the tasks to the team and review the tasks of the team
• Author or identify Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for RISTS and Confidential applications
• Perform Computer System Validation using Operational Qualification (OQ) and Performance Qualification (PQ) protocols on RISTS and Confidential which are used in Clinical Trial Management systems based on FDA 21 CFR Part 11, Good Clinical trial practices (GCP) 21 CFR 50, 21 CFR 56
• Validate HL7 standards on patient Data transfer to Confidential application using ‘HAPI Test Panel’
• Authored OQ, PQ and DQ protocols related to functional validation and database validation test cases and prepared Test Case Index for each module and uploaded into ALM 12.0.
• Reviewing of the Test case index, Test cases, and Test Traceability matrix prepared by the team members
• Perform REST API testing on Confidential web resources using ARC tool
• Integration testing on IPCT and PODSS application
• Validate Tumour response images upload using Aspera Software in a structured manner
• Perform Database Testing after creation/update the data in Confidential and PODSS applications
• Perform Database testing after migrating the Legacy data
• Performed Smoke testing, Functional. Compatibility, Database testing and System Testing.
• Performed compatibility testing on different Browsers (IE10, IE11, Chrome, Firefox, Safari)
• Perform defect validation and Regression testing on new builds in each sprint
• Deliver the deliverables on time by communicating & coordinating with the team.
• Interacting with client POC and gathering the required information related to RISTS project.
• Create and update the testing activity status in the JIRA application
• Upload and download the client related and project related documents from SharePoint
• Identifying UAT scenarios based on Sprint user stories for UAT testing.
• Prioritize the test cases to be executed based on the requirements severity and defect fixes.
• Verify and Validate the software based on corrective and preventive actions in the CAPA process
• Performed defect validation and Regression testing on new releases of RISTS project.
• Involved in Sprint planning meeting and business requirement calls conducted by PODSS and Confidential teams.
• Logging defects in JIRA v7.0 and conducting defect triage meetings with both business and development teams.
• Provided trainings to new & existing resources as part of Knowledge transfer.
• Prepared Validation Summary Reports with the release wise data and provided to client and developers

Environment: Oracle 12c, SQL Server 2012, VPN, SharePoint, Microsoft SQL developer, HP ALM 11.0 and JIRA,, Windows 7 OS

Confidential

QA Analyst

Responsibilities:

• Understanding the business flow and database architecture from the Client provided requirement Document.
• Analyse the requirements and identify the scope of changes based on risk-based approach and prepare impact assessment documents
• Involve in preparation of System Design Specification (SDS) and Design Qualification documents which is documented based on User Requirement Specifications and configuration changes.
• Prepare Validation Plan and traceability matrix documents
• Author or identify Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for RISTS and Confidential applications
• Perform Computer System Validation using Operational Qualification (OQ) and Performance Qualification (PQ) protocols on RISTS and Confidential which are used in Clinical Trial Management systems based on FDA 21 CFR Part 11, Good Clinical trial practices (GCP)
• Perform Requirements Ambiguity testing and Posting the ambiguities in ALM.
• Execution of Stored Procedure in SQL developer with Production data and checking backend process in server and databases.
• Authored & Execution of Store Producers related test case and validating the data transformation to the respective tables.
• Author Operational Qualification (OQ) and Performance Qualification(PQ) protocols for eResearch project applications and Perform FDA Compliance testing on eResearch Project applications.
• Preparation of Test data for the Store Producers using production data.
• Prepare the Test Strategy and Test Plan.
• Deliver the deliverables on time by communicating & coordinating with the team.
• Point of contact for any queries on Store stored procedures, Protocol build, Consent build and CRF
• Interacting with client POC and gathering the required information.
• Identifying the high-level scenarios and deriving detail test cases.
• Prioritize the test cases to be executed based on the requirements severity.
• Participate in the Risk management meetings in the project and come up with the mitigation & contingency plans for the risks identified
• Regression testing on existed application builds.
• Involved in Scrum calls, Sprint planning meeting, Retrospective Meeting and business requirement calls.
• Logging defects in QC 11(ALM) and conducting defect triage meetings with both business and development teams.
• Giving trainings to new & existing resources as part of Knowledge transfer. Working as Internal SQA for MDACC project.

Environment: Oracle 11g, SQL Server 2008, VPN, SharePoint, Microsoft SQL developer, HP ALM 11.0, Windows 7 OS

Confidential

QA Analyst

Responsibilities:

• Compute test execution efforts in terms of requirements gathering, design reviews, test case authoring, test execution estimation and status reporting and test execution metrics computing for every release and tracking of same for any deviations.
• Generate test plan / test strategy for test execution and foresee risks by generating risk management plans, project resource maintenance by generating configuration management plan and communication plan as required for steady project management.
• Interact with business analysts to understand client’s requirements, analyse software specifications to gain a better understanding of the application.
• Review of functional test cases, system test cases and performance test cases as per Testing Requirements and upload them to test management tool as per client specification
• Author master test cases, prepare data sheets for optimum coverage of test requirements and finally map the master cases to data sheets
• Track, supervise & mentor daily smoke test, functional testing and system testing for upcoming code drops, compute applicable metrics and status reporting of test execution to all stake holders.
• Posted more functional defects and identified the critical issues.
• As a SQA coordinator maintained project documents and involved in risk management.

Environment: Oracle 10g, ALM 11.0, Mainframe systems, VSS, Windows XP Professional