SUMMARY

• 10+ years of diversified experience as a Sr. Business Analyst in the pharmaceutical/Clinical & pre - clinical industry, known for the ability to develop and implement processes that positively impact the compliance results.
• Thorough understanding of the Software Development Lifecycle (SDLC) and Validation Lifecycle with the emphasis on the manual and automated testing.
• Extensive experience in providing technical leadership for the team on Informatica Powercenter, Informatica MDM (Siperian), IDD (Informatica Data Director), IDQ (Informatica Data Quality).
• Results driven Business Analyst with proven track record with 10+ years' experience building and implementing Business Intelligence,Master Data Management (MDM).
• Experience as Salesforce.com Business Analyst in Business Requirements Analysis Requirement Gathering and Gap Analysis
• Expertise in developing Business Intelligence, data warehousing, and ETL applications using tools such as Tableau Multi-skilled Life Sciences professional with progressive experience in the Laboratory, Operations Management, Leadership, Data Management and Customer Relations.
• Creating user requirements document by interacting with the end users and developers.
• Knowledge and working experience in GLP, GMP and GCP suites.
• Have deep functional and technical knowledge of the ServiceNow platform as well as experience-delivering medium to large-scale ServiceNow implementations.
• Experience in the Software Development Life Cycle (SDLC) methodologies including Agile Scrum and Waterfall.
• Experience in Configuring Applications using ServiceNow tool
• Participation in 21 CFR Part 11 and GxP compliance assessments and Implementation of 21 CFR Part 11 regulations.
• Hands on experience of Pharmaceutical Commercial, Sales Operations and Inventory management, Life Sciences.
• Understanding of Data models and Data Marts that support the Business Intelligence Data warehouse.
• Solid Knowledge on Regulatory Processes (FDA - 21 CFR Part 11, GxP Validation and compliance audit)
• Extensive experience with Pharma covigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
• Support the testing, validation and implementation of large-scale regulated systems for pharmaceutical and life science clients.
• Expertise in creating various project documents like BRD, FRD, Data mapping, data definition document, Big Data migration related documents, Test Plan, Test case, UAT Document etc.
• In-depth Upgrade & Implementation experience in various Oracle Cloud ERP Release 9,10, 11, 12, 13 Versions.
• Experience on monitoring tool with ServiceNow integration.
• Experienced with cloud marketing, sales (CRM Salesforce), Wave Analytics, Discovery,quote to cash C2C,and CPQ.
• Demonstrates broad knowledge of GxP (Pharmaceutical manufacturing, Biotech, Medical Devices Healthcare and Life Sciences).
• Understanding of Data models and Data Marts that support the Business Intelligence Data warehouse.
• Knowledge of industry practices and regulatory expectations as they relate to commissioning, qualification, and validation programs.
• Participation in 21 CFR Part 11 and GxP compliance assessments and Implementation of 21 CFR Part 11 regulations.
• Experience in the field of Information Technology in the Healthcare-Life Sciences / Pharmaceutical / Pharmacy Benefit Management PBM / encompassing business systems planning, procedural development, reporting and validation.
• Quality and detail oriented, ability to interact with all levels of the organization and influence decision making.
• Experience in analyzing quantitative & qualitative business data to develop business requirement documentation (BRD) & functional specification.
• Have considerable expertise in Metadata Management, Data Analysis, Data Profiling & Quality, Data Governance and Master Data management (MDM).
• Expert in Requirement Analysis / System Specification Analysis.
• Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current pharmaceutical industry standards.
• Proficient in SQL Queries, Stored Procedures and PL/SQL programs for Data Analysis purpose and data mining.
• Skilled in implementing Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) in the clinical research environment.
• Good understanding of statistical design of experiments, process capability analysis, FMEA, FTA hazard analysis, failure analysis and six sigma tools.
• Expertise in Building reporting using BI Tools such as PowerBI,Tableau, Cognos.
• Performed Data mapping in XML and performed data analysis with SQL Queries.

TECHNICAL SKILLS

Testing Tools: Rational Test Manager, Mercury Test Director, Win Runner, Load Runner, Rational Robot, Quick Test Professional

Bug Reporting/ Testing Tools: Bugzilla, Test Director, JIRA, HP ALM, Quality Center

Operating Systems: Windows XP, OS/400, MVS, UNIX

Hardware: IBM PC, AS/400, Dell and Sun

RDBMS: Oracle, MS Access, SQL Server, DB2

Web Technologies: HTML, XML

Web Browsers: Netscape, Internet Explorer 5.5

Other Tools: Microsoft Office, Documentum, Watson LIMS, Lab Vantage LIMS, Labware LIMS, SAP R/3,ELAN

Project Management: MS Office Suite, MS Project, MS Visio

Business Modeling Tools: Rational Rose, Rational SODA, Requisite Pro, Clear Case, Clear Quest, Microsoft Visio

Languages: C, C++, Java, C#, XML, SQL, UNIX

Operating Systems: Window NT/95/98/2000/XP/Vista, Unix

Change Management Tools: Rational Clear Quest, Test Director

BI Tools: SSRS, Business Objects, COGNOS, SSIS, Informatica, SSAS, PowerBI, Tableu, Cognos

Methodologies: OOAD, RUP, UML, SDLC, JAD, Six Sigma, CMM, RAD, SCRUM

PROFESSIONAL EXPERIENCE

Confidential, San Rafael, CA

Sr. Business Analyst

Responsibilities:

• Compliance with federal regulations, including 45 CFR 46, 21 CFR 11, 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.
• Used Tableau to quickly build powerful calculations from existing data, drag and drop reference lines and forecasts, and review statistical summaries.
• Responsible for Reviews, edits and formats all GxP Audit reports.
• Worked on Oracle database for use as a data warehouse, designed data warehouses, Performed upgrades of the database and data warehousing software to new releases Managing schema objects, such as tables, indexes, and materialized views
• Effectively used data blending feature in tableau.
• Creating and developing roles in dev environment which can be assigned to users based on their functionality thus restricting their access to the entire system of ServiceNow and giving them limited access based on the requirement.
• Prepared and operational zedstrategic and tactical marketing plans and budget forlife science products.
• Responsibility included the full SDLC management for designing, analyzing, developing, testing, Implementation and application support
• Developed batch files to transfer files from Local server to AWS & validation process at AWS to publish document.
• Managed data migration and off-shore application development and enhancements to a proprietary global Web-based drug safety (pharmacovigilance) reporting system (incorporating CIOMS / PSUR & EMEA).
• Analyzed BI tools such as Tableau, Cognos visualizations and dashboards using Tableau Desktop.
• Build the data lakes for loading the data from different source system and again export data from HDFS to other source system, which helps in avoiding the data duplication and time savings.
• Worked with Life Sciences in the large enterprise Pharma space.
• Created Validation Plan, Testing Plan, Test Report, Validation Summary Report for large GxP projects
• Designed the Test Cases, Test Plans for all the processes using HP ALM and tracked defects on JIRA, hence was part of Black Box Testing, and was part of Interface Testing, System Testing.
• Authored Amgen Specific End-To-End test scenarios to test complete business process for ‘Small Molecules’ and ‘Large Molecules teams’ which involves different instruments are interfacing with LIMS.
• Well versed with reporting packages (SSRS), databases (Microsoft SQL Server), programming Language (SQL, R) and Data visualization tools (Tableau and Microsoft PowerBI)
• Built a successful life science and healthcare management consulting practice.
• Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment
• Demonstrated expertise utilizing ETL tools, including SQL Server Integration Services (SSIS), Data Transformation Services (DTS), and Data Stage and ETL package design, and RDBM systems like SQL Servers, Oracle, and DB2.
• Worked extensively with Data Warehouse / Big Data technologies including Hadoop,Hue, Hive, Ambari, and Teradata.
• Electronic Trial Master File (eTMF) upgrade
• Involved in developing, and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations
• Worked on Tableau’s trend analyses, regressions, and correlations for tried and true statistical understanding.
• Reviewed administrative and clinical practices and procedures: point of care, scheduling, registration, clinical documentation, patient care, and charge entry, medical coding and diagnostic testing procedures associated with multiple business units.
• Worked on relational databases, Data Warehousing, ETL, fact and dimensional model and Business Intelligence - Reporting for life sciences.
• Responsible for translating business data requirements into conceptual, logical, & physical data models using Erwin Data Modeler.
• Worked on various modules of ServiceNow like Incident management, Change management, and Problem management,Service Catalog, User Administration, and Reporting.
• Involved in the Development and Testing phases of SDLC
• Expertise In Informatica MDM Hub configurations, including Data modeling & Data Mappings (Landing, Staging and Base Objects), Delta detection, Match and Merge rules, writing and customizing user exits, and configuring Business / Informatica data director (IDD) applications.
• Created custom enhanced reports in ALM and using SQL queries and Business Views
• Review of promotional materials as per the Label specifications compliance with GxP
• Organized and maintained documents like Requirements Traceability Matrix (RTM) and Test Strategy.
• Developed, analyzed and reviewed test scripts to check the functionalities of the application for 21CFR part 11 compliance.
• Developed/Analyzed BI tools: Tableau and Cognos workbooks from multiple data sources using Data Blending.
• Implementation & deployment of MES (Manufacturing Execution System) system for Kaiser.
• Created PL/SQL Scripts and Stored Procedures fordatatransformation on thedata warehouse.
• Responsible for mapping business information to Data Lakes and used it for data repository.
• Performed unit testing in all stages of MDM and ETL from where data releases.
• Set up Discovery Module to load Configuration Items and Relationships into ServiceNow
• Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Provided training on ServiceNow process, operations, answer questions, resolve issues and capability to all required teams.
• Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines
• Authored OQ test scripts for SAS Clinical Connector and wrote test scripts and test plans.

Environment: SQL, Oracle ERP, IMS, HP ALM, Quality Center, EMC Documentum, .Net, eTMF, HTML, XML, BI Tools: PowerBI, Tableu, Cognos, SQL,Oracle, SAP, Tableau, Rational Requisite Pro, AWS, Rational Rose, Erwin, UML, SQL, MS-Office, MS Project, MS Visio, Test Director.

Confidential, Exton- PA

Sr. Business Analyst

Responsibilities:

• Analysis of the Functional Requirements for Bio-Analytical.
• Responsible for Writing of OQ scripts for modules-Assay Design, Plan Analytical Runs, Study Design, Study Configuration, Bi-Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in client’s LIMS system.
• Used data analysis techniques to validate business rules and identify low quality missing data in the existing Amgen enterprise data warehouse (EDW).
• Provided analysis of ServiceNow design and the existing Client's configuration/customization, and recommended ServiceNow oriented best practice solutions.
• Expertise in Veeva Vault configuration, presently working as Veeva Vault consultant to end-to-end product and then implementing in the environment
• Directed the clinical trial data capture and worldwide data collection systems for various therapeutic areas,also worked on data quality and data catalogue.
• Life Sciences operations knowledge in Clinical Trial Management and Pharma Sales & Marketing industry e.g., knowledge in Protocol Design, Site Administration, Enrolment, Fields Monitoring, Medical Affairs, Regulatory Affairs, Project
• Experience with Tableau for Data Acquisition and data visualizations
• Created custom enhanced reports in ALM and using complex SQL queries and Business Views
• Utilized Software Development Life Cycle (SDLC) to configure and develop process, standards procedures.
• Work with the development team to configure Veeva as per requirements
• Involved in validating all Network Devices that are interacting with Lab Instruments.
• Conducted routing Internal inspections of regulated systems (GMP, GCP, GLP) to assure validation procedures have been followed in compliance with company, divisional and departmental policies and predicated rules.
• Involved in meetings with users to develop Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).
• Bridging the gap between technology and compliance by implementing systems for thelife scienceindustry.
• Worked in Scrum/Agile methodology and created/prioritized product backlog items for MITA & EDW
• Used Erwin to transform data requirements into data models.
• Managed Approved E-mail content development and integration into Veeva CRM
• Defect identification and reporting through HP ALM QC
• Expert in report creation for Life Sciences Operation Team.
• Involved in Dry run applications before validated testing phase.
• Worked on POC in Hadoop, HIVE & Scala programming and Informatica Data Lake using Hive tables.
• Involved in preparing Master Validation Plan for SAP R/3 system implementation.
• Prepared Validation Plan for every project implementation and involved in full cycle validation throughout all phases in SDLC.
• Developed Validation/SDLC Deliverables including User Requirements and System Requirements Specification documents (URS & SRS).
• Developed Tableau workbooks from multiple data sources using Data Blending
• Worked as Veeva CRM that includes Administration, Configuration, Implementation, Development and Support activities
• Support the testing, validation and implementation of large-scale regulated systems for pharmaceutical and life science clients.
• Worked with SAP functional team to validate the transactions and modules to be complaint with 21 CFR Part 11 and GMP regulations.
• Wrote test cases for functionality, system and integration testing and tested the application manually and using HP ALM.
• Participated in SDLC including Design, Analysis, Development of Use Cases based on the functionality.
• Performed match/merge and ran match rules to check the effectiveness of MDM process ondata.
• Took part in the process of modeling the different data marts using Erwin.
• Participate in discussions with different business functions to capture requirements and create the requirements documentation to support MDM initiatives.
• Lead teams of IT and business resources during MDM testing initiatives to support successful MDM implementations.
• Wrote and prepared risk management documents, including Risk Management Plans, Pharma covigilance Plans and Risk Minimization Plans.
• Worked on Veeva CRM Functionalities and has knowledge of Veeva Vault
• Engaged with business units and stakeholders to define scope of effort, work deliverables, and project plans for data warehouse project which was due for migration tosnowflake.
• Worked on Datamodeling, Advanced SQL with Columnar Databases using AWS.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries
• Experienced in testing Lab vantage LIMS system, which is an Laboratory Information Management System involving functional and user-acceptance testing.
• Involved in development of Master Test Plans and Test Scripts in OQ and PQ/UAT.
• Involved in Pre-execution review of OQ and PQ/UAT scripts and incorporated negative test steps to challenge the system. Also involved in Post review to verify the compliancy and documentation of scripts according to GDP regulations.
• Managed regulatory compliance and quality assurance within the guidelines of FDA 21 CFR part 11 documentation
• Worked on Building, publishing customized interactive reports and dashboards, report scheduling using Tableau server.
• Conducted Gap Analysis to demonstrate that LIMS System remains in a validated state in its life cycle.

Environment: J2EE, SQL Server, XML, HL7, UML, Oracle, AWS, Erwin, Veeva CRM, Veeva Vault, MS Visio, eTMF, Tableau, MS Office, MS Project, Filenet.

Confidential, Memphis - TN

Business Analyst

Responsibilities:

• Wrote User Stories along with Acceptance Criteria as a part of the AGILE methodology.
• Involved in development, review and execution of validation documents, generating and executing SOPs and protocols, conducting testing, and preparing final summaries.
• Responsible for reviewing and developing Drug Safety/Pharmacovigilance SOPs and Word Instructions.
• Ensured that day-to-day Pharma covigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
• Analyzed & validated acceptance criteria are documented for user stories on multiple projects in AGILE.
• Responsible for managing and enhancing multiple instances of Veeva Vault
• Created the Master Data Management(MDM) Console configurations like Stage Process configuration, Load Process Configuration.
• Developed Requirement Traceability Matrix and Risk Assessment documents.
• Prepared Deviation reports as part of OQ testing and kept track of all deviations occurred.
• Developed Test Summary Reports and Validation Summary Report.
• Analyzed business requirements and developed test plans, test cases to cover overall quality assurance system testing.
• Worked with SMEs to update and finalize create the new SAP FI Business Processes including those that will still rely on data from legacy systems post go-live.
• Involved in GxP (Pharmaceutical manufacturing, Biotech, Medical Devices Healthcare and Life Sciences).
• Tracked defects in HP ALM and worked with QA team to resolve defects.
• Involved in Change Control Processes to keep track of all the changes made to the validated environment.
• Approve SDLC defects closure with relevant root causes and suitable CAPA in JIRA & HP- ALM.
• Proficient in implementing methodologies such as Agile and Waterfall while working in the Software
• Expertise in Veeva Vault configuration, presently working as Veeva Vault consultant to end-to-end product and then implementing in the environment.
• Make sure the SDLC Agile methodologies and practices are sustained across the SDLC Life cycle.
• Work with ETL team to understand data load/data mapping issues to make sure data warehouse tables are developed as per the business requirements.
• Prepared and operationalstrategic and tactical marketing plans and budget forlife scienceproducts.
• Maintained formulary tables in PBM system to add, update or remove drugs and change pricing.
• Developed Operational Qualification Test Plan and documented OQ test strategy.
• Involved in preparation of Operational Qualification (OQ) test scripts as part of OQ test cycle.
• Worked closely with QA team to identify the test scenarios and test cases.
• Procedures.
• Integration with ALM and JIRA and other tools using HP Synchronizer.
• Perform statistical analysis, process capability analysis, FMEA, FTA (Fault Tree Analysis) hazard analysis.
• Tested PBM/ Pharmacy claims in order to obtain best outcomes for patients/ pharmacy.
• Responsible for Manage to movedatafrom multiple sources into targets and Datamarts and Datawarehouse.
• Developed test scripts to ensure that the system is compliant with 21 CFR Part 11 and GMP regulations.
• Prepared test scripts for data base updates and audit trials.

Environment: MS Office Suite, Oracle ERP, GEMS, HP ALM, Quality Center, Document Analyzer, SharePoint, MS-Visio, MS Excel, MS Access, Mainframe, ETL, UML, Veeva CRM, Veeva Vault, Rational Requisite Pro, eTMF, Rational Rose, Rational Clear Case, Rational Clear Quest, html, JAVA, Asp, MS Window Server.