- 12+ years’ experience as a Business Analyst in Pharmaceutical domain on various areas like Claims Processing, Reimbursement, Inventory management and Pharmacy Benefits Management.
- Proficient in BusinessWriting,BusinessProcess Flow,BusinessProcess Modeling,Business Analysis and Testing various methodologies.
- Experience in facilitating Joint Requirement Planning (JRP) sessions wif BusinessUser Groups, conducting Joint Application Development (JAD) sessions wif IT Groups and Conflict Management wif Project team members.
- Experienced in analyzing business specification documents, Designing Test Plans, Test Strategy and Test cases Verifying and validating Test cases and effective QA implementation in all phases of Software Development Life Cycle (SDLC)
- Knowledge Rational Unified Process methodology, Use Cases, Software Development Life Cycle processes.
- Hands - on experience wif Software Development Lifecycle (SDLC) methodologies like Waterfall, V-shape and Agile models, documenting the project andvalidationdeliverables, gatheringbusiness, functional,systemrequirements, developing testing andvalidationprotocols (IQ/OQ/PQ), summarizing reports and finalvalidationpackages.
- Knowledge of 21 Code of Federal Regulations (21 CFR Part 11, 210 and 820) FDA, and GxP's including electronic records, electronic signatures, systemvalidationstrategies and documentation.
- Competent in Creating Unified Modeling Language (UML) diagrams such as Use Case Diagrams, Activity Diagrams, Class Diagrams, navigational flows, story boards, UI specifications and Sequence Diagrams.
- Extensive experience in developing Use Cases, creating Screen Mockups, Gap Analysis and Impact Analysis, SWOT analysis, Cost Benefit Analysis, Risk Analysis.
- Proven expertise in developing Test Cases, Test Plans, Procedures and Traceability Matrix and documenting defects using HP QC and HP ALM. Collaborate and monitor Black-Box Testing, Smoke Testing, User Acceptance Testing (UAT) and Regression Testing.
- Highly motivated team player wif excellent Interpersonal and Customer Relational Skills, Proven Communication, Organizational, Analytical, Presentation Skills, and Leadership Qualities.
Regulatory Tools: 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211, FDA, ValidationProtocols (IQ, OQ, & PQ/UAT), cGxP, Script,ValidationReports
BusinessSkills: BusinessProcess Analysis & Design, Gap Analysis, JAD Sessions Requirement Gathering, and Use Case Modeling
Methodologies: SDLC, Agile and Waterfall
Testing Tools: HP ALM, HP QC, JIRA
Microsoft Tools: MS Word, MS Excel, MS Power Point, MS Access, MS Project
Confidential, New Brunswick, NJ
- Gather requirements by conducting meetings and brainstorming sessions wif end users and SME and document them using Requisite Pro - the documentation tool offered by Rational
- Developed, documented, and executed test plans to assess the integrity and accuracy ofbusinessprocesses, module functionality setups and modifications, enhancements, customizations, and patches.
- Conducted GAP Analysis after analyzing AS-ISbusinessprocess and the TO-BEbusiness process.
- Using MS-Visio analyzedbusinessrequirements and process through Use Cases, Class, Sequence, and Activity diagrams, and adapted UML standards to define modularized Data Process Models.
- Created validation products including Validation Scripts, Toolkits, Documentation, and Services (21 CFR Part 11, GAMP 5).
- Responsible for coordinating wif team members in locating, tracking, organizing and verifying validation documentation for GMP compliance,GxPand regulatory requirements.
- Executed the test cases using Quality Center based on the test plan and in accordance wif Good Documentation Practices (GDP) and documented results aspartof IQs, OQs and PQs.
- Validated Standard Operating Procedures to ensure compliance wif FDA regulations and 21CFRPart11 requirements
- Reviewed test cases and scripts and documented the results as per the FDA regulations.
- Authored and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for the LIMS application
- Validated the requirements & user stories in JIRA and ensured its traceability in various applications like JIRA and session recordings. Defects were tracked, reviewed, analyzed and compared using HP Quality Center.
- Identified risks and reported on testing progress and results, log defects, facilitate defect resolution and document final test results in HP ALM and project management teams.
- Documented and tracked all product defects wif use of SQL. Developed tables, Views, Stored Procedures and Triggers using SQL Scripting. Wrote Complex SQL queries and optimizing SQL Queries
- Worked on SQL queries and stored procedures for QA testing and data validation of Metric Reports.
- Extensive use of MS Office tools like MS Access, MS Word, MS Excel, MS PowerPoint MS Project for data migration in to the CI System Knowledge Data Base in Microsoft SharePoint.
- Worked extensively wif the QA team for designing Test Plan and Test Cases for the User Acceptance Testing.
Confidential, New York City, NY
- Created, gathered and documented the business needs of the Licensingbusiness department through various requirements gathering techniques.
- Modified stored procedures and functions to support efficient data storage and manipulation as perBusinessRequirement Document (BRD).
- Facilitated JAD sessions involving the management, development and user teams for clarifying requirements and facilitating better communication. Designed Use Cases using UML and managed the entire functional requirements life cycle using SDLC.
- Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data
- Analyzed and reviewedvalidationdeliverables likeValidationPlan, Risk Assessment,ValidationSummary Report in compliance wif 21 CFR Part 11, GAMP 5 and GMP FDA Compliance Regulations.
- Involved in Pharmaceutical Plan changes from one plan to other plan wifin Group, subgroup, class combinations
- Wrote test cases and applied the test case design concepts to complete thevalidation deliverables in different phases of the project for IQ, OQ and PQ.
- Involved in preparingValidationdocumentation considering all aspects of the ComputerSystemsSDLC and Laboratory Instrumentsystemvalidationlife cycle, in accordance wif FDA design control and regulations, particularly 21CFRPart11, 211 & 820. Verified for theGxPstandard is met for entry into each cycle of SDLC based on SOP.
- Assigned tasks to work on Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook
- Wrote documentation for all aspects in accordance wif FDA regulations, particularly 21CFR Part11, Protocols, (IQ), (OQ) and (PQ) Specification. Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
- Involved in Computer Systems Validation according to FDA Guidelines,GxPand 21CFR Part 11.
- Performed Quality Assurance responsibilities by reviewing validation deliverables for various projects for compliance wif SDLC, 21CFRPart11 requirements andGxPregulations.
- Used broad range of technologies, including business process tools such as Microsoft Project, MS Excel, MS PowerPoint, MS Access, MS Visio, MS Word and technical assessment tools.
- Wrote SQL statement and stored procedures in Oracle for extracting as well as writing data.
- Involved in reporting projects using SQL Server Reporting Services like tabular report, matrix report, chart report, pie charts and sub-reports, drill-down and ad hoc. SQL query optimization and tuning by choosing proper access plan.
- Build SQL scripts, indexes and complex queries for analysis, extraction & creation of data on client server.
- Executed and validated Test cases to ensurebusinessrequirements, functional and design requirements are validated.
- Assisted to develop the Test Plan, Test Cases and Test Scenarios to be used in testing based onBusinessRequirements, technical specifications and/or product noledge.
- Conducted User Acceptance Testing, gathered and documented User Manuals andBusinessRules.
- Gathered the business requirements from the client and end users keeping in mind their need for the application (Internet, Claims, Provider, and Recipient) and documented it for the developers.
- Implemented Standardized process throughout the Software Development Life Cycle (SDLC)
- Conducted JAD sessions wif business users, SME and stakeholders located remotely and in different time zones to elicit requirements.
- Created Business Requirement Document (BRD) and functional requirement documents (FRD) based on the requirements of the project. Created Source to target data mapping documents identifying key data elements and prepared Data Flow Diagrams.
- Followed the UML based methods using Microsoft Visio to create: Use Cases Diagrams, Activity Diagrams, State Chart Diagrams, Sequence Diagrams and Collaboration Diagrams.
- Facilitated collection of User Requirements andBusinessRequirements fromBusinessUser Group such as to documentBusiness/User/Functional/Technical Requirement Specification using MS Project, MS Word and MS Visio that provided appropriate scope of work for technical team to develop prototype and overall system.
- Developed IQ/OQ/PQ Scripts for Track Wise using HP Quality center. Authored and reviewed Requirement Traceability Matrix (RTM). Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
- Reviewed and Validated Computer Systems in compliance wif 21 CFR Part 11 andGxPFDA Regulations.
- Planned and executed decommission of Quality systems as perGxPguidelines and FDA regulations.
- Followed pharmaceutical/medical device regulations like FDA 21 CFR Part 11 and FDA 21 CFR part 820
- Evaluated supplier special processvalidation(IQ/OQ/PQ) as part of the remediation and based on the gaps found, Assess Compliance and product Risk Assessments and present the finding to management.
- Providedvalidationguidance to SAP functional teams to ensure compliance to the regulations like 21 CFR Part 11 and GMP.
- Accurately and efficiently captureinventorycount data in MS Excel or on paper count sheets as instructed by the Team Leader
- Used JIRA to plan and create test cases and assigned them to the testing team and gathered the results (passed/failed).
- Used HP Quality Center to create and execute functional tests for each component and also to submit, track and validate defects
- Used Query Analyzer, Execution Plan to optimize SQL Queries. Designed and implemented SQL queries for report / data validation.
- Assisted in various types of testing, such as functional, regression, user acceptance (UAT), negative and installation testing.
Confidential, Cambridge, MA
- Conducted one to one interview wif Portfolio Manager to gatherBusinessRequirements and involved in the documentation ofBusinessRequirement Documents
- Attended JAD sessions wif the stakeholders as a scribe and capturedbusinessrules, system rules and process flow for each requirement
- DevelopedBusinessRequirement Document as well as High-Level Project Plan. Developed Functional Specification Document and Supplementary Specification (non-functional) Document.
- Participated in the Logical and Physical Design sessions and developed Design Documents.
- Identified all necessary Business and System Use Cases from requirements, created UML diagrams in Microsoft Visio including use Case Diagrams, Activity Diagrams, Entity Relationship Diagram and Sequence Diagrams.
- Reviewed of promotional materials as per the Label specifications compliance wifGxPGLP, GCP, GMP, GDP FDA Compliance Regulations.AddressedGxPGLP, GCP, GMP FDA's CFR part 211, CFR Part 210 approach to compliance issues, and summarized the outstanding problems and issues.
- Extensive used of MS Office tools like MS Access, MS Word, MS Excel, MS PowerPoint MS Project for data migration.
- Designed and executed Test Cases for system testing, regression testing and Integration Testing/End to End Testing in HP QC
- Designed and implemented basic SQL queries for QA Testing and Report / Data Validation.
- Responsibilities included Test Planning, Test Case development and test script execution for Worked in creating Test plan, Test cases and executing the Test scripts. Participated in Integration, Regression, Performance, Functional and System Testing and User Acceptance Testing (UAT).
Confidential, Ardsley, NY
- Gathered, documented and validated requirements in Waterfall SDLC methodology consulting wif the lead developer.
- Worked wif clients to better understand their needs and present solutions using structured SDLC
- Conducted JAD sessions to gain consensus on various issues related to the project. Acted as a facilitator and also as a scribe on different occasions.
- Involved in interviewing Subject Matter Experts (SMEs) and carefully recording the requirements in aBusinessRequirements Document (BRD) and Functional Requirement Document (FRD)
- Analyzed and Conducted Data Mapping to ensure that the all required data was mapped in the correct Fields.
- Analyzed thebusinessrequirements, performed GAP analysis to defineBusinessProcess Improvement model wifbusinessprocess flows and UML diagrams using Smart draw and Power Designer
- Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio.
- Responsible for functional documentation FRD and system analysis of the application
- Used JIRA to create, maintain and organize backlog of features, stories and tasks.
- Loaded requirements in HP Quality Center for System testing.
- Executed basic and complex SQL queries for data analysis and validation.
- Coordinating QA & UAT process wif testers & end-users; Defect report/review/fix