- 10+ years’ experience as a Business Analyst in Pharmaceutical domain on various areas like Claims Processing, Reimbursement, Inventory management and Pharmacy Benefits Management.
- Proficient in Business Writing, Business Process Flow, Business Process Modeling, Business Analysis and Testing various methodologies.
- 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.
- 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.
- Superior knowledge of 21 Code of Federal Regulations (21 CFR Part 11, 210, 211 and 820) FDA, and GxP's (GDP, GMP, GLP and GCP) including electronic records, electronic signatures, system validation strategies 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 with 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, Validation Protocols (IQ, OQ, & PQ/UAT), cGxP, Script, Validation Reports
Business Skills: Business Process 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
- Gather requirements by conducting meetings and brainstorming sessions with 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 of business processes, module functionality setups and modifications, enhancements, customizations, and patches.
- Conducted GAP Analysis after analyzing AS-IS business process and the TO-BE business process.
- Using MS-Visio analyzed business requirements and process through Use Cases, Class, Sequence, and Activity diagrams, and adapted UML standards to define modularized Data Process Models.
- Wrote documentation for all aspects in accordance with FDA regulations, particularly 21CFR Part11, Protocols, (IQ), (OQ) and (PQ) Specification.
- 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 with 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 with the QA team for designing Test Plan and Test Cases for the User Acceptance Testing.
- Created, gathered and documented the business needs of the Licensing business department through various requirements gathering techniques.
- Modified stored procedures and functions to support efficient data storage and manipulation as per Business Requirement 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 reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance Regulations.
- Involved in Pharmaceutical Plan changes from one plan to other plan within Group, subgroup, class combinations
- Wrote test cases and applied the test case design concepts to complete the validation deliverables in different phases of the project for IQ, OQ and PQ.
- 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 ensure business requirements, functional and design requirements are validated.
- Assisted to develop the Test Plan, Test Cases and Test Scenarios to be used in testing based on Business Requirements, technical specifications and/or product knowledge.
- Conducted User Acceptance Testing, gathered and documented User Manuals and Business Rules.
- 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 with 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 and Business Requirements from Business User Group such as to document Business/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.
- Followed pharmaceutical/medical device regulations like FDA 21 CFR Part 11 and FDA 21 CFR part 820
- Evaluated supplier special process validation (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.
- Provided validation guidance to SAP functional teams to ensure compliance to the regulations like 21 CFR Part 11 and GMP.
- Accurately and efficiently capture inventory count 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.