Skills

Please use this table to list the skills noted in the Required/Desired section of the Peoplefluent requirement. In addition, please respond with the years of experience for each skill and the last time each skill was used. Add or delete rows as necessary.

Employment History

Confidential

Senior Business Analyst

Responsibilities

• Performed Requirements Gathering and Analysis, interviewed the SME's Subject Matter Experts by conducting JAD sessions through screen
• Gathered and documented business and technical requirements BRD, FRD from both formal and informal sessions and validate the needs of the business stakeholders.
• Worked on Product development cycle PLM including Requirement gathering, Analysis/Designing, Development and Testing
• Performed Gap Analysis to identify the deficiencies of the current system and to identify the requirements for the proposed system.
• Participated in and contributed to As-Is and To-Be Process Modeling Sessions, and build process models.
• Worked on Requirements Traceability Matrix RTM which defines mapping between requirements in project and corresponding test cases
• Created use case models, activity diagrams and sequence diagrams using MS Visio
• Conducted highly interactive JAD sessions with project stakeholders, subject matter experts SME's , users, QA team and project management team for requirement gathering.
• Worked with the Project Manager on various Project Management activities like keeping track of Project Status, Deadlines, Environment Request, and Compliance Issues.
• Worked as EBA Enterprise business analyst on MED-D projects as well on Adjustments projects.
• Helped and trained junior BA's, coordinated and reviewed FR documents that is prepared by junior BA's.
• Reviewed the functional test plan prepared by Quality Assurance QA team and assisted QA team in preparing the test cases, test scripts, test plans and also in tracking the bugs using Quality Center.
• Used Quality Center to create and Maintain Test requirements, for defect tracking, reporting and analysis.
• Was responsible for tracking issues that are detected and updating the status of existing issues based on the daily meetings with the off-shore team.
• Used AS400 SQL queries to extract/analyze the data from the database.

Confidential

Senior Business Analyst

Responsibilities

• Gathered requirements and analyzed them to convert into functional requirements.
• Conducted JAD sessions to elicit business and system requirements.
• Analyzed User and Functional Requirements.
• Developed and maintained the 21 CFR Part 11 Assessment.
• Involved in deviation investigations, reviewing and preparing SOPs and quality system development, documentation control and equipment/facility qualification.
• Supervised and wrote the Test Scripts and analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Executed PQ Scripts for LabWare LIMS system.
• Used share point as central repository for managing and sharing document for complete projects.
• Worked with the business users and with different levels of management to identify requirements, use cases and to develop functional specifications using the agile methodology for software development.
• Preparing a Data Migration Summary Report stating the data migration activities taken place while loading the static data in the LIMS application.
• Maintained the Requirements Traceability Matrix RTM .
• Preparing Deviation Reports that proves the root causes of the failures in the pre-executed copy and the resolutions taken to resolve the issues.
• Involved in reviewing Corrective and Preventive Action CAPA and drafting Remediation Plans for the project management approval after the GAP analysis.
• Reviewed the URS and prepared the Detailed Test Plan and Test Cases
• Developed, reviewed and executed the test plans, cases and test conditions.
• Involved in designing and writing training manual templates, project planning and document proofs.

Confidential

Business Analyst

Responsibilities

• Authored User Requirement Specification URS .
• Wrote Validation Master Plan VMP to implement LabWare LIMS.
• Wrote the Validation Assessment for the management to understand the importance of validation of core business functionalities in particular and of whole application in general.
• Used CMS for data mapping and diagrams.
• Wrote the Requirement Traceability Matrix RTM to map test cases to requirements.
• Assisted in identifying the Critical and Non-Critical requirements while preparing the UFRS.
• Accountable for ensuring that new technologies, application enhancements, and application fixes are tested in accordance with company standard operating procedures and methodologies.
• Involved in continuous process improvement and for identifying and maintaining a clear and measurable Development Process that is deployable throughout the enterprise using Agile
• Involved in tracking the changes such as New Functionality, Enhancements and Bug fixes
• Created and executed Test Scripts for System Validation and User Acceptance Testing UAT .
• Worked on 21 CFR Part 11 Assessment and GxP Assessment to find the compliance gap in the system.
• Reviewed IQ Scripts to verify installation of different modules of the system
• Created OQ Scripts to verify functionality of different modules of LabWare LIMS.
• Executed PQ Scripts for LabWare LIMS system.
• Wrote Test Plans for testing whether the sample reports generated by LabWare LIMS were according to the specifications.
• Reported Bugs to the development team using Test Director.
• Prepared performance reports and project status reports for efficient project management.

Confidential

Business Analyst

Responsibilities

• Developed and maintained the 21 CFR Part 11 Assessment.
• Coordinated with System Analyst to make the Server and Machines qualified through complete IQ, OQ and PQ procedures
• Involved in deviation investigations, reviewing and preparing SOPs and quality system development, documentation control and equipment/facility qualification.
• Supervised and wrote the Test Scripts and analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Involved in the process of preparing the RFP, Vendor assessment, Vendor Audit of Documentum software
• Maintained the Requirements Traceability Matrix RTM .
• Analyzed User and Functional Requirements.
• Meeting with technical writer and project team to point out deficiencies in requirements and ways to cover it.
• Performed Functionality, GUI, Regression and Back End Testing using WinRunner.
• Developed, reviewed and executed the test plans, cases and test conditions.
• Involved in designing and writing training manual templates, project planning and document proofs.