SUMMARY

• Over 7+ years of Industry experience in Pharmaceutical’s domain as a Business Analyst with solid understanding of Business Requirements Gathering.
• Expertise in creating various project documents like BRD, FRD, Data mapping, data definition document, Data migration related documents, Test Plan, Test case, UAT Document etc.
• Experience in producing documents like Business Requirements Documents (BRD), Functional Requirement Specifications (FRS), Software Requirement Specifications (SRS), and Creating Request for Proposals (RFP).
• Knowledge on writing Business Use Cases, Business Rules, logical analysis and change management of requirements.
• Strong understanding of Success Factors Admin and employee central which includes Foundation Objects, Succession and Corporate data models, Pick list management, Reporting Events, Workflows/Business Processes.
• Experienced in configuring the Success Factors systems according to new or changing business requirements.
• Experience in facilitating Joint Requirement Planning (JRP) sessions with Business User Groups, conducting Joint Application Development (JAD) sessions with IT Groups and Conflict Management with Project team members.
• Extensive experience in working in all phases of the System's Development Life Cycle (SDLC) namely Analysis, Design, Development, Testing & Implementation.
• Experience in Using JIRA for User Story requirements management throughout the Agile Sprints and development life cycle.
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation and also in validating Laboratory Information Management System (LIMS).
• Experience in Creating business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Experienced in reviewing all SDLC documents, protocols and SOPs to ensure they meet GxP and FDA regulations.
• Experienced and professional employee with knowledge in regulatory compliance, GMP, Quality Assurance Audits, Document control, Quality Assurance/Quality Control activities in the pharmaceutical.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science, GMP, GCP, GLP, CAPA, GRP, EMR, EHR & QMS.
• Strong expertise in FDA regulations, GxP suites (GAMP4 & GAMP5, GDP), Computer System (CSV) & Equipment Validation, Documented, LIMS and Trackwise.
• Good knowledge of 21 CFR Part 11, CFR Part 58, CFR Part 210, CFR Part 211, Regulatory forms (510 K) and conducting Risk Assessments, Gap Analysis, CAPA etc.
• Experienced in preparing and executing validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start - up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project.
• Expertise in configuration, performance tuning, installation of Informatica, & in integration of various data sources like Oracle, MS SQL Server, and XML, Flat files into the staging area and Design ETL processes that span multiple projects.
• Experience in SQL query skills (Oracle and TSQL) in analyzing and validating SSIS ETL database data warehouse processes.
• Experience in writing complex SQL queries involving multiple table’s inner and outer joins, stored procedures.
• Expert level knowledge in Project Management me.e., Project Scoping, Planning, Estimating, Scheduling, Organizing, Directing, Controlling, Budgeting and Drafting Remedy Procedures.
• Experience in Functionality Testing, User Acceptance Testing, Database Testing, Regression testing and Risk Based Testing.
• In-depth knowledge of conducting User Acceptance Test (UAT), data quality checks using SQL, gap analysis and Requirement Traceability.
• Proficient in guiding the developing team and QA team to make the project done by the time as date of delivery.
• Expertise in working with QA team and Developing Team while handing over the project and testing.
• Good communication skills and Skilled in problem solving the issues in the project.

PROFESSIONAL EXPERIENCE

Confidential - Cambridge, MA

Sr. Business Analyst

Responsibilities:

• Conducted interviews, sessions, workshops to gather and document business requirements (BRD) and subsequently translate them into functional requirements (FRD).
• Participated in series of workshops to gather, document, and finalize business requirements and proposed workflows.
• Documented and submitted business requirements documents, functional specifications document, data mapping sheets, process business flow diagrams and test cases for approval.
• Documents operational objectives by working closely with business managers to study business functions; gathering information; evaluating output requirements and formats.
• Conducted JAD sessions, created Use Cases, workflows, screen shots and Power Point presentations for the Web Applications and maintained product quality under GMP and ISO 9000 requirements.
• Performed Defect Tracking & Management in JIRA. Generated automated daily reports using JIRA API.
• Work directly with each Revenue Cycle Management department to design, create and report employee productivity and other key KPI's by department.
• Documented requirements using the Agile User Story format and created User Stories and Acceptance Criteria in Rally. Responsible for UI mock-ups and documentation attachments for Rally User Stories.
• Facilitated JAD sessions for ability to identify and document critical requirements through analysis.
• Strong knowledge of the Systems Development Life Cycle (SDLC) models such as Waterfall.
• Created and executed training programs on quality systems, SDLC, GAMP, general GxP regulations and good practice.
• Participated in the validation of systems such as Enterprise LIMS, SAS upgrade, Regulated Spreadsheets, JD Edwards and several R&D server qualifications.
• Coordinated with R&D, clinical trials, manufacturing, regulatory affairs and know the process of NDA application.
• Created business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Represented department in cross-functional teams, projects, and GXP-related problem resolution.
• Maintained validation package based on the requirements to meet the GxP GLP, GMP, GAMP, GDP, and FDA 21 CFR Part 211 compliance.
• Worked along with cross functional team and facilitate cross functional team meetings to ensure on time delivery of product supply with Manufacturing Science & Technology, Quality, Supply Chain, Commercial, Legal, and Regulatory.
• Created System Retirement Plan, Data Migration Verification, Data Management Report and Final Retirement Report for Electronic Systems such as Calibration Manager, LIMS, Foxboro, CAPA, Chromatography Data System, Manufacturing Data, Training Management and Series Batch Assignment.
• Created validation transfer plans for four separate assays while collaborating with Marketing, R&D and Manufacturing.
• Worked with the team validating computerized laboratory equipment like Atomic Emission Spectroscopy (automated in process equipment) based on GAMP.
• Worked particularly on LIMS, handling data for lab and also processing, tracking, storing and reporting various analytical data and records. me worked both on static data and dynamic data.
• Involved in Data mapping specifications to create and execute detailed system test plans. The data mapping specifies what data will be extracted from an internal data warehouse, transformed and sent to an external entity.
• Responsible for providing sensitive credit data to the business readiness team, to support data migration from legacy to target systems.
• Performed Data mapping, logical data modeling, created class diagrams and ERP diagrams and used SQL queries to filter data.
• Used data analysis techniques to validate business rules and identify low quality missing data in the existing Amgen enterprise data warehouse (EDW).
• Worked on designing the SSIS packages to export data from various sources like Oracle, SQL Server, and MS Access etc. to SQL Server database.
• Analyzed data in legacy applications to determine data migration/integration complexity, to identify data gaps against new requirements or conflicts across multiple legacy applications.
• Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
• Participated in data quality checks and ensured correction of data quality issues from source systems and improved reference data sourcing for facility, counter party and other relevant attributes.
• Involved in design and implementation of Progression and Regression Tests and reviewed Test Plan and Test Cases.
• Assisted and executed Test cases and test scripts per Functional Specifications of the application. Documented test/cases, test results, test procedure and reported to client.

Confidential, North Chicago, IL

Business Analyst

Responsibilities:

• Prepared High-Level Logical Data Models and BRD’s (BusinessRequirement Documents) supporting documents containing the essentialbusinesselements, detailed definitions, and descriptions of the relationships between the actors to analyze and documentbusinessdata requirement.
• Performed requirement gathering using both formal and informal sessions through interviews, NetMeeting, questionnaire, video conferencing, JAD sessions and conference calls.
• Managed and prioritized user stories using JIRA. Worked with the development team to identify blockers and provide resolution.
• Used JIRA for User Story requirements management throughout the Agile Sprints and development life cycle.
• Prepared and developed various UML Diagrams such as Timing diagrams, business flow diagrams, Activity diagrams and Sequence diagrams using MS Visio so that developers and other stakeholders can understand the business process.
• Documented and reviewed all the laboratory records through LIMS and controlled forms following the GLPs.
• As the continuation of earlier local project, leading Integration testing efforts between MES and Labware LIMS to test the fully globally implemented automated functionality of the Interface.
• Conducted meetings periodically with various stakeholders at various phases of the Manufacturing Process Flow to discuss open issues and resolve them.
• Conducted JAD secessions with over fifteen different teams including laboratory scientists, manufacturing engineers and executives.
• Involved in validating a web-based application in accordance with GMP regulations, which is used in manufacturing processes.
• Created business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Interpret and apply FDA regulations as they pertain to GxP computer systems, lab equipment and process validations GxP.
• Created and reviewed Validation Deliverables for Data Integration between Clinical Trial Management System (CTMS) and Drug Shipment Tracker and between TrialTrak and Electronic Data Capture (EDC).
• Performed Environmental Monitoring and Conducted routine audits of data, Information, procedures, Equipment and Systems to Ensure Compliance of SOP, GMP and other Regulatory Requirements.
• Conducted routing Internal inspections of regulated systems (GMP, GCP, GLP) to assure validation procedures has been followed in compliance with company, divisional and departmental policies and predicated rules.
• Involved in the re-mediating electronic audit trial in SAP R/3 of all the GMP sensitive transactions with respect to 21 CFR part 11.10b and part 11.10e.
• Participated in test planning and executing the interface between Labware LIMS and MES (Integration and functional testing of samples data flowing back and forth between the two applications.
• Regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory.
• Worked on daily basis with lead Data Warehouse developers to evaluate impact on current implementation, redesign of all ETL logic.
• Worked on delivering a long series of overlapping Data Integration, Data Warehouse and Business Intelligence project releases to implement Smart Grid Analytics.
• Worked with SQL queries using MS Access for data manipulations and involved in writing scripts for patient online registrations using the VB Script.
• Created SQL scripts to find data quality issues and to identify keys, data anomalies, and data validation issues.
• Conducted backend testing using SQL queries to validate data for database and Used SQL queries for retrieving data from database for executing user specific test cases.
• Report defects in test management tool and manage them throughout their lifecycle using JIRA.
• Worked on SQL server reporting services (SSRS) delivering enterprise, Web-enabled reporting so creates reports that draw content from a variety of data sources.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues with QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).

Confidential, South San Francisco, CA

Business Analyst

Responsibilities:

• Gatheird business requirements through brainstorming, interviews and surveys.
• Coordinatedwithvarious stakeholders for system requirements, product integration documentation, testing and implementation of the systems.
• Helped in Analyzing application requirementswithUML modeling (MS Visio) and documented Dialogue application output management and FileNet Enterprise Content Management solutions.
• Created and maintained user stories in JIRA for better understanding of the requirements for the development team also use JIRA for bug tracking.
• Interpret and document technical specifications, such as data dictionaries, data flows, API specs Prioritize backlog to prep for agile ceremonies.
• Worked in Agile framework throughout all the phases of Software Development Life Cycle (SDLC).
• As a team managed financial services and planned analysis, Involved in Task Board updating as a team member.
• Mapping of data for the early-stage development clinical trials study through an application named Trial Setup.
• Met with client groups to determine User Requirements and Goals, thus converting User Requirements into Business Requirements and User and Technical Requirement Specification.
• Facilitated collection of Functional Requirements from system users, and prepared Business Requirement documents.
• Involved in design and development of Clinical Trials Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Worked with project managers and assisted with the implementation of the LIMS software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP guidelines.
• Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Maintained key records for purposes of Compliance review, QA/QC, and/or regulatory inquiry.
• Working on clinical trials/drug safety systems in Global Pharmacovigilance group to manage the study, data activity, analysis, financial, reports, product, market/sales on Argus Safety DB, and reporting tools.
• Followed a structured approach to organize requirements into logical groupings of essential business processes, business rules, and information needs, and ensured that critical requirements are not missed.
• Involved in Preparation of Logical Process and Data Models that contained set of diagrams and supporting documents containing the essential business elements, detailed definitions, and descriptions of the relationships between the data elements to analyze and document Business Data Requirements.

Confidential - Somerset, New Jersey

Business Analyst

Responsibilities:

• As a team conducted brainstorming sessions with executive sponsors, project champion and stakeholders to document problems with existingCTMSand potential solutions.
• Gatheird business requirements through brainstorming, interviews and surveys.
• Worked on Creating Jira User Guide and performed training sessions to introduce Jira to the team.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
• Coordinatedwithvarious stakeholders for system requirements, product integration documentation, testing and implementation of the systems.
• Involved in working with agile framework throughout all the phases of Software Development Life Cycle (SDLC).
• Gatheird the User Requirements from the Business Users and the Business Sponsor.
• Helped in Developing the Functional Specifications based on the Business User Requirements along with the Lead Developer.
• Coordinated with the Lead Developer to set up and build the prototype of the application.
• Helped in creating a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.
• As a team created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Actively participated in project meetings and discussions.
• Peer review deliverables from project team members.
• Helped in Scheduling and documenting the formal and informal software design reviews.
• Helped in reviewing the test reports with the help of QA team.