SUMMARY

• Overall, 9+ years of professional experience as a Validation/BA/QA in Pharmaceutical and Biopharmaceutical industries.
• Experience in analysing and requirements gathering and writing system functional specifications including use cases.
• Experience in Rational Unified Process (RUP) methodology, Use Cases, Software Development Life Cycle (SDLC) processes, Object Oriented Analysis and Design (OOA/D).
• Experience in cGMP, GAMP, GxP, Risk - Based approaches.
• Involved in budgeting, Materials requirements planning (MRP) as per orders.
• Strong knowledge of Project management skills includes time estimation, task identification, and scope management.
• Experience in Integrating Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning.
• Responsible for coordinating and participating in cross-functional CRO partnered clinical studies to deliver clinical trials on time and in compliance with Regulatory agency guidance and specifications, and internal procedures.
• Experience with CLP, CLM, Emporia, IMS Data, Pharmaceutical Sales Marketing, Sales Force Automation. 21 CFR Part 11 and adherence. Follow 21CFR Part 11 methodologies for validated systems in a structured SDLC environment. Trained in Good Clinical Practices GCP for work with the Clinical Trials area and GXP for work in R&D areas.
• Experience in Pharma industry compliance and regulatory standards like HL7, EDI, ANSI X12, SOX, ISO, CMM, Joint Commission, GMP, and GxP.
• Detailed knowledge ofc GMP, GLP and FDA regulationsandcompendiarequirements fordrugs, biologicalandbiotechnologicalproducts, including documentation of activities.
• Collaborated with developers, testers and CRO SMEs ensuring documentation of requirements from scoping document and business requirements plan to completion and approval of Business Requirements Document (BRD). Quick study regarding various clinical research data issues and challenges.
• Reviewed tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the Labware LIMS application.
• Experience in validation protocols and test case execution for Labware LIMS.
• Experience in reviewing all completed IQs/OQs, checklists, and other documents for accuracy and compliance with GxP and FDA rules and regulations.
• Expert on Working extensively on data mapping and data modelling from the backend data.
• Expert inconducting JAD sessions with business usersand technology teams to vet out business requirements, analyse system design, create prototypes and designGraphical User Interfaces GUI.
• Organized Joint Application developments (JAD), Joint Application Requirements sessions (JAR), Interviews and Requirement Elicitation sessions.
• Proficient in working with systems such as Track wise, LIMS (Laboratory Information Management Systems), Documentum and SAP.
• Strong experience writing Test Plans and Test cases using requirements, use cases and design documents.Performed Data mapping in XML, XQuery and performed data analysis with SQL Queries.
• Good experience of working with various bug tracking tools like HP Quality Centre, Rational Clear Quest and JIRA and a very good understanding of the Defect Life Cycle.
• Experience and skills in creating design models and Extensive use of UML/RUP for modelling views using tools like Microsoft Visio.
• Experience in creating UML Diagrams and Data Models including Use Case Diagrams, Activity Diagrams, Deployment Diagrams, Data Flow Diagrams (DFD) and Entity-Relationship diagrams using Rational Rose and MS Visio.
• Experience in creating Functional Specifications, UI specifications and UI prototypes.
• Experience in requirement analysis techniques such as Business Process Automation, Business Process Improvement, and Business Process re-engineering.
• Experience in using HP Quality Centre Test Management tool/ALM, Test Rail and JIRA for creating and executing Test cases, Defect Tracking and Defect Reporting and HP Quick Test Pro (QTP) for functional and Regression testing.
• Facilitated Change Management across entire process from Project conceptualization to Testing through Project Delivery, Software Development and Implementation Management in diverse Business and Technical Environments.

PROFESSIONAL EXPERIENCE

Confidential, Baltimore, MD

Sr Validatioan Analyst

Responsibilities:

• Involved in understanding of Business Requirements Gathering, Data warehousing, Data Modelling, Evaluating Data Sources, Translating Requirements into Specifications, Application Design.
• Worked on compliance and regulatory standards like SOX, ISO, CMM, Joint Commission, GMP, and GxP.
• Responsible for reviewing and approving glass syringe product transfer activities from R&D to Commercial Operations.
• Involved in the validation of Labware Laboratory Information Management System (LIMS) to be used by Quality Management group to store project related regulatory and non-regulatory documents in a controlled manner.
• Involved in preparing Business Requirement Documents (BRD's) after the collection of Functional Requirements from System Users that provided appropriate scope of work for technical team to develop prototype and overall system.
• Used JIRA applications and Confluence together to find out all the integration points, great time saving features, and to check upon exactly which JIRA application and version could be need.
• Prepared UAT Materials, including the UAT Process, UAT Test document which would include step-by step process for UAT as well as all the tests that would cover all requirements.
• Involved in writing FDA21 CFR compliant test plans, test scripts and completed executions of IQ/OQ/PQ.
• Involved in defining end-to-end detailed process models using BPMN in MS Visio and Lucid Chart
• Extensively worked on MS Visio and Lucid chart to make Use Case models, Activity Diagrams, and Business Process workflows.
• Extensively worked on business requirements into user stories and tasks for agile projects. Created more efficient process for project delivery using JIRA and Confluence.
• Involved in working with the Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards.
• Involved in creating and maintaining business rules in Performance point server for data cubes to enhance data cube security. Developed XML schema for data retrieval and processing to improve system flow through metrics.
• Involved in evaluating competing EDMS tools and qualifying them for management decision. The EDMS tools were interfaced with both LIMS to generate Data Transfer Reports which were configurable for immediate submission.
• Authorized installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) deliverables for Labware LIMS
• Extensively worked along the SharePoint developers and involved in developing SharePoint UI sites and sub-sites for PPD Quality Assurance and cGMP Laboratory.
• Involved in using JIRA for tracking the issue and handled the requirements.
• Extensive use of MS Office tools like MS Access, MS Word, MS Excel, and MS PowerPoint MS Project for data migration into the CI System Knowledge Data Base in Microsoft SharePoint. Used the ODBC/SQL to migrate all data to one database before uploading it into the Knowledge Base.
• Extensively maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines.
• Involved in using MS SharePoint for the purpose of managing documents and for hosting websites which was used to access shared workspaces and documents.
• Involved and worked on approving product transfer activities from R&D to Commercial Operations.
• Involved in participating in User Acceptance Testing (UAT) by creating test strategy document, test scenarios, executed test cases and logged defects in JIRA.
• Involved in validating and defining 21 CFR Part 11 compliance strategies for Labware LIMS.
• Involved in participating in 21 CFR Part 11 and adherence.
• Involved and followed 21CFR Part 11 methodologies for validated systems in a structured SDLC environment. Worked on GCP for the Clinical Trials area and GXP for work in R&D areas.
• Involved in Data mapping, logical data modelling, created class diagrams and ER diagrams and used SQL queries to filter data.
• Involved in data mapping and data definition documentation. Interacted with ETL programmers, database administrators, project managers and business managers.
• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for the LIMS system.
• Involved in documenting various artefacts as per the FDA 21 CFR Part 11considerations as well as Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Interacted with users for verifying User Requirements, managing Change Control Process, updating existing Documentation.
• Executing and validating Test cases to ensure business requirements, functional and design requirements are validated.
• Extensively 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.

Confidential, North Wales, PA

Business/Validation Analyst

Responsibilities:

• Involved in gathering business requirements from the end users and management.
• Involved in creating high quality functional requirement specifications and supporting documents for business systems.
• Extensively defined on charter, scope, schedule, and resources for projects productizing R&D programs, managing (and often defining and delivering) customer needs via marketing requirement documents (MRD) and product requirement documents (PRD) with program milestones, user documentation and QA, increasing profitability while building a best practices organization.
• Involved in creating and maintaining user stories using Confluence JIRA, coordinated efforts to maintain daily product backlog.
• Involved in supporting clinical admin and operational support activities including end user, user access, account configuration, system data reconciliation for GxP and 21CFRPart11 complaint CTMS.
• Involved in the testing efforts of Claims Adjudication, Managed care, Interfaces, Web Portal, Claims Payment & Financial functional areas.
• Involved in developing Use Cases, Activity Diagrams & Sequence Diagrams using MS Visio, Lucid chart.
• Extensively managed Argus and Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
• Extensively designed, authored, reviewed, and revised Clinical Data Management Plans and Drug Safety Technical Reports are FDA 21 CFR Part 11 compliant.
• Involved in gathering requirements in the form of user stories and detailing the functional and non-functional requirements using the JIRA tool.
• Involved and assisted in the technical management of CRO and other external service providers.
• Involved in working on Adaptive Trial designs for improving the efficiency of drug development by saving time and money to run clinical trials as well as providing more information to select the right dose(s).
• Involved in assisting the implementation in GXP environment to adhere to regulatory and risk management compliance.
• Involved in developing reports based on the Clinical Trial protocol. Identified areas of risks, assessment, monitoring, having security and audit controls in place.
• Involved in performing the reverse engineering of the CRO report.
• Involved and installed, authored, and managed reports using SQL Server Reporting Services.
• Involved in validating different Customized components of the LIMS modules.
• Extensively interviewed screening and evaluation of numerous applicants for various Clinical IT and IT related positions in the organization.
• Extensively Interfaced with Business Owners and departmental Quality Assurance organization to ensure that all documents satisfied GxP and FDA requirements.
• Extensively Configured Vault for R&D and CRO team for Promo Mat and Quality Doc to meet the timeline.
• Involved in complex Nautilus LIMS configuration to meet end user requirements for LIMS users.
• Involved in implementing and validating 21 CFR Part 11 compliance strategies for Labware LIMS.
• Extensively assisted in performing quality checks of Informed Consent Forms (ICF) and Feasibility Questionnaires (FQ) for CRO partnered studies to improve data management while ensuring compliance to FDA 21 CFR 50.
• Involved in managing the planning and requirements phase for the implementation of a Laboratory Information Management System (LIMS).
• Extensively worked on writing subroutines for uploading static data into Labware LIMS from csv files.
• Involved in conducting interviews with end-users to collect requirement and business process information.
• Extensively supported Labware LIMS implementation in a corporate Pharma environment including Requirements, OQ, PQ, Trace Matrix, and Test Case.
• Involved in creating traceability matrix to ensure that the requirements are traced to the test cases.
• Extensively ensured that extremely thorough, effective, and organized test process is implemented and delivered the highest quality product.
• Involved in developing the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document.
• Involved in working on creating the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Extensively analysed, designed, and successfully completed the full product development life cycle of a high visibility, high throughput screening Laboratory Information Management System (LIMS).
• Extensively worked closely with the project team in planning, coordinating and implemented QA methodology on various phases of the application.
• Involved and interacted with the developers to report and track bugs using Test Director.
• Extensively Analysed results of Regression Testing as performed by Testers using QTP and held meetings with Developers and Testers.

Confidential, Boston, MA

Business/Validation Analyst

Responsibilities:

• Involved in performing GAP analysis of business requirements (Client) to vendor requirements. Assessed vendor documentation.
• Extensively gathered requirements and designed an inventory control system for the R&D labs, for chemical and biologics, integrated into the ELN/ electronic lab notebook project having many EHS/Environmental Health and Safety implications.
• Extensively facilitated JAD sessions with SMEs and business analysts from other feeder systems for a detailed analysis and a better understanding of impact of various projects on each other.
• Involved in participating in review and approval of cGMP processes, procedures, documents, and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Non-conformance, Corrective Action/Preventative Actions (CAPA)
• Involved in monitoring Burn down charts to determine the progress of work during sprints on the completion of tasks in the sprint backlog and to track the velocity within the time boxes using JIRA tool.
• Extensively created functional requirement documents for the impacting projects.
• Extensively Prepared Business process models: used Lucid chart to create process flow diagrams for management and mapping the logical aspects of the process.
• Involved in creating meeting minutes in SharePoint and Confluence for Sprint Planning sessions.
• Extensively Created UAT plans with several test cases for each project to ensure that the system runs smoothly after the proposed enhancements or changes have been made.
• Extensively Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Extensively performed numerous Ad-hoc requests, financial reports involving SQL scripts, UNIX, and Teradata.
• Extensively Used MS Project to manage schedules, deadlines and resources and collaborate on the project Authored Validation plan.
• Extensively Coordinated Installation Qualification (IQ) activities at the client site.
• Involved in ensuring that production records and testing results are complete, accurate, and detailed according to written procedures and cGMP requirements.
• Involved in the planning and Coordination of testing activities for Operational Qualification (OQ) and Performance Qualification (PQ) Protocols. Involved in documenting test plans.
• Extensively coordinated with Business and IT team for the preparation of validation deliverables.
• Extensively prepared Requirements Traceability Matrix (RTM) and drafted Validation Summary Report (VSR).
• Extensively worked on Validation of Legacy Systems in compliance with 21 CFR Part 11.
• Extensively used Microsoft Visio and Lucid Chart to create UML diagrams; use cases, activity, and process flow diagrams to better capture requirements.
• Involves in managing the Defect Lifecycle - conducting daily defect tracking meeting, reporting, and validating the defects, assigning the open defects to developers, and re-testing the fixed defects using JIRA.
• Involved in creating, organising and Scheduling Test cases for UAT in JIRA.
• Involved in working on Complete 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems.
• Involved in validating computerized laboratory equipment like Atomic Emission Spectroscopy (automated in process equipment's) based on GAMP 4.
• Extensively proposed solutions to reporting needs and develop prototypes using SQL and Business Objects that address these needs.
• Responsible for business requirements gathering and technical requirements analysis and documentation for File Net-based document management system.
• Involved in performing dry run and peer run of the authored test scripts to detect deviations and fix the bugs as part of quality review.
• Extensively documented user-friendly compliance reports for installation qualification, operating qualification, and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards.
• Involved in preparation of documents for Computer systems validation documents in accordance with 21CFR, part 11.
• Involved in working on all the lab data electronically at its source and a full complement of instrument interfaces.
• Involved in working on validated (GxP) environment, building validation requirements, and managing QA approvals.
• Extensively attended quality review of existing documentation and validation plans, test scripts, and summary reports both pre- and post-execution.
• Extensively worked with the QA testing team to develop the test plan, test conditions and test cases to be used in testing based on business requirements, technical specifications and/or product knowledge.

Confidential, Tarrytown, NY

Business/Quality Analyst

Responsibilities:

• Involved in gathering knowledge of the Healthcare Benefits plans with in the CAMS application, with the HEDIS information which is useful for the consumers and other members for improvement in the quality of the service.
• Extensively worked on developing SQL and SSIS ETL business intelligence solutions, data wrangling, migrate disparate source data into a centralized data mart structure for HEDIS and SSRS reporting, SSIS flat file processing, advanced SSIS features for data mapping, data conversion.
• Extensively maintained up-to-date knowledge of EHR software by attending lectures on health information technology.
• Involved in defining the scope of the Renewal project and implementing Business rules for the project.
• Extensively attended team meetings, coordinating with the stakeholders, HCEO, developers, PMs, and QAs to analyse, and understand the Business requirements and help make changes in requirements.
• Extensively communicated greatly with the various groups of the team during gathering requirements so that I can understand what the Business, stakeholders and SMEs needed.
• Involved in working on reviewing, analysing, and evaluating the Business data systems that provide data to various data sources like SSA, IRS, Equifax, and Fed Hub.
• Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows.
• Reviewed and updated end to end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures.
• Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.
• Created and Reviewed several Change Controls for Quality validation plan, Risk Analysis Plan, IQ, OQ, PQ Protocols.
• Wrote the OQ, PQ Test case Issues in the Test Track Pro and actively participated in discussion with the validation lead regarding the issues.
• Managed the overall protocol execution process including resource management, scheduling/timeline management, incident management, and status reporting.
• Reviewed and edited URS documents as per the changes requested by the users during the project.
• Created Risk assessment and Quality validation plan for the whole project.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Performed Performance Qualification (Such as Load/Stress, Volume and Response Time) and User Acceptance Tests (UAT) and also documented them.
• Involved in the development of the Information Protection and Risk Management assessment.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• Involved in managing Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
• Extensively attended interviews with technical R&D team, stakeholders, and IT team to gather and document requirements for designing online portal for the product line.
• Extensively partnered with business stakeholders and R&D team to define project scope, gather requirements, define & improve processes, and implement global Clinical and Medical Affairs solutions for handling research data and patient records.
• Involved in creating various Data Mapping Repository documents as part of Metadata services (EMR).
• Involved in working on Healthcare system implementation including enterprise Electronic Medical Records (EMR) and Electronic Health Records (EHR) software.
• Extensively worked with individual departments to communicate SharePoint purpose, application, and vision for the future.
• Involved in validating HL7 interface transactions on the Hospital Information System (HIS).
• Involved in reviewing of Acceptance Criteria given in the User Stories before Testing/Scripting the User Stories.
• Participated in executing the Test Scripts from TFS and hence logging/linking defects to specific User Stories if the script is failed.
• Extensively worked on End User Coordination for Patient Management (ADT), Scheduler, Physician Access Emergency Services, Inpatient Nursing Station Pharmacy, Labs, Radiology HIM, Respiratory Therapy and Long-term care
• Extensively worked on Brainstorming Scenario Discussions on designing Physician Access Application workflow.
• Extensively worked very closely with LAB HOD to design the functional specifications of LIS, Quality control of Equipment's and Handled requirement gathering for Clinical Documentation, Patient Chart, CPOE, Order Sets, and Assessments, Care plan.
• Involved in JAD sessions and recommended Business Process change for migrating from Manual to Electronic.
• Involved in working on various supply chain initiatives to provide in-depth analysis and business insights to identify key saving opportunities and to facilitate the execution process.
• Involved in worked with QA team to create test scenarios, test plans and test cases based on requirements and functional specifications. Conducted User Acceptance Testing (UAT).

Confidential, CT

Business Analyst

Responsibilities:

• Worked with the account managers, managements, and report requestors to gather requirements, get report requests.
• Wrote Business Requirements, analyzed them and tested them.
• Owned the entire reporting process. Interacted with the ETL team, developer(s), management, and account holders to get the requirements, document them, design templates, and write specifications.
• Designed report templates based on the requests by account managers.
• Designed Functional Specification Documents for the reports.
• Analyzed trading partner specifications and created EDI mapping guidelines.
• Completed the documentation of Claims Scenario’s for the source system
• Analyzed the existing claims process and specific business rule logic will be applied in the ACP model.
• Requirement gathered from R&D, clinical trial data, scientist, research assosiate, regulatory affairs, sales and marketing, medical library.
• Extensive use of Excel to create Functional Specification Documents & Templates.
• Designed the process flow diagrams for flow of information and report creation process.
• Documented all the changes in the initial templates and was responsible for Release Management.
• Reviewed Requirements & deliverables for delivery timeline.
• Used MS Visio to create Flow diagrams and Use Case Diagrams.
• Created the configuration document for custom setup for various user groups such as HR, marketing, R&D & sales, research analyst & investigators.
• Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos
• Coordinated with the developer, on day-to-day basis, during the development process.
• Tested the report for its content.
• Created reports using Business Objects / Crystal Reports based upon business requirements.
• Worked on Report Re-engineering Project and made enhancements to the system flow.
• Modified System flow diagrams using SDLC.
• Created Graphical representation of reports such as Bar charts, Pie charts etc as per the End user requirements using Business Objects and Crystal reports.
• 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).
• Worked with ETL team during the upload process.
• Helped with Data Mapping between the data mart and the Source Systems.
• Worked with SQL queries using MS Access for data manipulations.
• Worked as a liaison between the Business and Technology Department.
• Enhanced communication lines between executives, managers, and peers