SUMMARY

• Over 11+ years of diversified experience as a Sr. Business Analyst in the pharmaceutical 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. variety of CTMS, Data Management, Technical and Clinical Trial experience gives me the ability to fully understand business process of pharmaceutical Companies.
• 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.
• Participation in 21 CFR Part 11 and GxP compliance assessments and Implementation of 21 CFR Part 11 regulations.
• Skilled in implementing Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) in the clinical research environment.
• Experience in analysis, design, testing, deployment and maintenance of applications in JAVA/J2EE/XML/BPM applications using Appian 16.2, 16.3, 17.1, 17.X, 18.Xand Linux/Unix based environment.
• Expertise in designing, preparing and executing test cases using HP Quality Center/ALM 11.0 and 12.0.
• Expertise in Bug Reporting and Tracking using HP Quality Center and JIRA and interacting with development team members in fixing the defects
• Strong SQL Server 2005 skills to build optimal database structure. Familiarity with TOAD. Knowledge of Relational Databases, Data Warehousing. ETL concepts.
• Experience with expertise in CTMS, Clinical Trials, Business objects BOXI R2/ 3.1, 6.5, 6, 5.X (Webi/Deski)PL/SQL, Client Server Internet and Intranet technologies.
• Extensive experience in preparing and executing qualification protocols (IQ, OQ, PQ).
• Proficient in dealing with Standard Operating Procedures (SOPs), Test plan, Laboratory information management system (LIMS).
• Experienced working in a team-oriented, collaborative environment provided by Business analysis GLP GXP Clinical, GMP Use Cases, wire frames
• Implemented and maintained a GxP compliant QMS.
• Knowledge of industry practices and regulatory expectations as they relate to commissioning, qualification, and validation programs.
• 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.
• Expert in Requirement Analysis / System Specification Analysis.
• Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current pharmaceutical industry standards.
• Good experience in performing validation and periodic reviews for clinical systems SAS GRID and Veeva eTMF and CTMS
• 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.
• Excellent communication and documentation skills in the field of technical writing.

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

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

PROFESSIONAL EXPERIENCE

Confidential

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
• Worked in different types of Projects at ABBOTT such as CTMS Clinical Trial Management System, CDW Clinical Data Warehousing CDC Clinical Document Control .
• Configuration, Bi-Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in client’s LIMS system.
• Created custom enhanced reports in ALM and using complex SQL queries and Business Views
• Executed IQ, OQ and PQ testing protocols for Labware LIMS.
• Worked on ELN, SOP’s, LIMS, CTMS system integrations for the client.
• Responsible for initial and thereafter annual training for all employees for cGMP(21 CFR Parts 210, 211 and 820), cGLP (21 CFR Part 58).
• 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.
• Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts.
• Involved in conducting Performance Qualification (PQ) to test the performance of the system according to business requirements.
• Worked in different types of Projects at Parexel such as CTMS Clinical Trial Management System and CDC Clinical Document Control.
• Developed User Acceptance Test Plan (UATP) and User Acceptance Test Summary Report for UAT test cycle.
• Involved in writing Test Plans, Test Cases and Test Strategies using HP Quality Center and arranged triage calls between developers and testers so that the bug cycle was taken care and made sure that requirements didn't get deviated.
• Trained and coordinated IT Operations with procedure oriented schedules for rotating offsite tape copies or cloned tapes for disaster recovery purposes.
• 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).
• Defect identification and reporting through HP ALM QC
• Involved in Dry run applications before validated testing phase.
• 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).
• 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.
• Clinical Studies Tracking using CTMS database.
• Responsible for day to day support of enterprise backups and disaster recovery systems in a 7x24 support schedule.
• 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.
• Detailed evaluation of CTMS application OnPoint.
• Managed regulatory compliance and quality assurance within the guidelines of FDA 21 CFR part 11 documentation.
• Conducted Gap Analysis to demonstrate that LIMS System remains in a validated state in its life cycle.
• Prepared Traceability Matrix to keep track of relationship between all requirements and test scripts.
• Worked on multiple strategic client facing initiatives related to multiple clinical products like CTMS (Impact), EDC (Rave, DataLabs) Argus, Veeva, HER, RTSM, Medical Imaging, Medical Coding, Data Driven Monitoring (Trigger) and ePRO.
• Prepared Qualification Reports to qualify Barcode printers in manufacturing process.

Environment: J2EE, SQL Server, XML, HL7, UML, CTMS, Oracle, MS Visio, MS Office, MS Project, File net.

Confidential, San Rafael-CA

Sr. Business Analyst

Responsibilities:

• Actively involved in discussion with ‘Small Molecules’ and ‘Large Molecules teams’ in analyzing the business requirements and convert them into functional requirements.
• Translated Business requirements into user Documentations.
• Gathered business requirements and participated in the designing of the Validation Master Plan (VMP) and Testing Criteria.
• Handled Disaster Recovery with High Availability across Distributed Data Systems and Data Domains.
• Compliance with federal regulations, including 45 CFR 46, 21 CFR 11, 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.
• Created Functional, Technical specifications and use cases for new CTMS Reports.
• Conducted technology comparison, tool/solution assessment and solution selection from several potential solutions, including SharePoint, Clinical Trial Management System CTMS and customized systems.
• Involved in validations, Flows and Process Modular design using Appian.
• Analyzing business requirements and doing modeling of complex business process using tools such as IBM Blueworks Live, IBM Process Designer and Appian Enterprise BPM Suite.
• Upgraded Disaster Recovery backup and recovery documentation including databases
• 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.
• Upgraded projects from ALM 12.01 to 12.55.
• Standardized ALM workflow across the organization defining templates.
• Standardized ALM roles to restrict user access.
• Created custom enhanced reports in ALM and using SQL queries and Business Views
• Worked with Thermo team in developing Design Specification document.
• Designed and authored validation protocols for LIMS application.
• 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.
• Migrating and upgrading projects from old version of Test Director to Test Director or Quality Center or ALM.
• Providing ALM trainings to the new project users and Managers on usage of ALM modules.
• Execute stage gate assessments as per the SDLC SOP to ensure the custom developed/ configured Software Quality is bug free, defect less and zero production roll-outs in the UAT.
• Design and manage PBM benefit plans for multiple accounts.
• Provided Disaster Recovery support for clients using EMC Networker, Arc Serve, Tivoli, Data Protector, Windows Server and multiple operating systems in an EMC SAN environment across data domains. Utilized EMC Networker SNAP for backup and recovery.
• Worked closely with Thermo team in producing and executing all required documents.
• Created and tracked deviations occurred during testing process.
• Reviewed IQ/OQ/PQ’s for client requirements.
• Involved in analyzing system specifications, design and development of test plans.
• Analyzing business requirements to develop functional and detail design specifications of the application.
• Reviewed defect/reports and assign valid defects to the relevant developer/ development manager using HP Quality Centre, JIRA and follow the defect life cycle.
• Worked on developing and testing functionality for the subgroups module like PBM.
• Implementation of test plans based on business requirements technical and specifications and interactions with Business and System Analysts.
• Implemented Disaster Recovery for all production servers using EMC Networker and NAS.
• Generated and executed annual internal audit programme for key functions and business units that fall under GxP Regulations in all territories where INDIVIOR have businesses, business partners and market product.
• Create applications using Appian Enterprise BPM Suite.
• Help on-board new Appian applications in Appian platform.
• Involvement in documentation/execution of test cases. Analyzing the test results, resolving and managing discrepancies/defect using " HP ALM"
• Identified, developed and executed Test Cases Manually.
• Involved in conducting stress test and volume test against the application.
• Conducted Performance testing, Multi user testing and Regression testing.
• Executed SQL queries to validate application results with database results.
• Customized Help and prepared the user guide for the GSSP application.
• Developed and conducted system and user acceptance tests on completion of system testing before installation of the application on user environment.
• Processed multiple PBM/ Pharmacy claims using QS1 pharmacy system in order to obtain a more efficient process of increasing claim reimbursement.
• Created new mappings in Informatica to pull CTMS data in to warehouse.
• Implemented SEI CMM, ISO and IEEE standards throughout the Quality Assurance Life Cycle and documented the entire Testing Process in MS Word.
• Ensured the execution of UAT test cases and documentation of the test results.
• Liaised with lead business users (Analyst, QC Coordinator/QC Reviewer) and developed system process flows and User Requirements Specifications.
• Identified key work streams for testing based on risk analysis.
• Authored OQ and PQ test scripts to challenge all regulatory and security requirements.
• Identified critical functionalities used by the users for OQ testing.
• Led/facilitated Client Acceptance testing (OQ) with a group of 13 system users across multiple sites.
• Performed review of OQ test executions and created fault reports and deviations as required.
• Authored responses to audit findings.
• Set up new process to track PBM performance guarantees via SharePoint workflow.
• Led/facilitated Performance Qualification with on site and remote site system users.
• Authored OQ test scripts for SAS Clinical Connector and wrote test scripts and test plans.
• Involved in Authoring of Requirement Traceability Matrix for client needs.
• Performed Non Compartmental Analysis on SAS data.

Environment: SQL, IMS, HP ALM, Quality Center, EMC Documentum, .Net, HTML, XML, CTMS, Oracle, SAP, Rational Requisite Pro, Rational Rose, UML, SQL, MS-Office, MS Project, MS Visio, Test Director.

Confidential, Memphis - TN

Business Analyst

Responsibilities:

• Involved in validation of Labware LIMS system rollout project.
• Developed Validation Strategy and documented in Validation Plan.
• Prepared Operational Qualification and User Acceptance Test Plans.
• Wrote and executed Operation Qualifications and Process and Product Validations.
• Involved in development, review and execution of validation documents, generating and executing SOPs and protocols, conducting testing, and preparing final summaries.
• Performed extensive research into business strategies for establishing an independent PBM and working directly with more established PBMs in the process.
• 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.
• Took an active part in sizing of the CTMS project.
• Created Project charter and RAM for the CTMS-Noetix integration Project.
• Directly report and interact with IT Management, IT staff and end-users to plan and implement technology solutions for IT Disaster Recovery Operations.
• Oversight and execution of a risk based GXP Supplier and Partner management program including Pharma covigilance and IT software / software as a service (SaaS) providers
• Utilized Veeva Vault software for routing process of GMP documentation.
• Performed under Regulatory Compliance (GxP, FDA/GLP).
• 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.
• Developed Master Test Plan and system test scripts for an Oracle Clinical upgrade project as part of computer system validation.
• Involved in validation of Oracle Clinical business processes in accordance with EMEA and FDA regulations.
• Approve SDLC defects closure with relevant root causes and suitable CAPA in JIRA & HP- ALM.
• 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.
• 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.
• Included negative test steps in the test scripts to challenge the system against system requirements.
• Developed test summary reports to summarize the test results according to company Standard Operating Procedures.
• Supported all phases of testing and defect resolution in Appian BPM.
• Implemented Appian Sites.
• Worked with business teams to understand requirements and patterns and ensure consistency in design across applications built on the Appian platform.
• Integration with ALM and JIRA and other tools using HP Synchronizer.
• Participation on software project teams to review and analyze software documentation/project deliverables associated with the Software Development Lifecycle.
• Developed the validation test plans for quality assurance of the medical instruments in accordance with regulatory standards.
• Developed short, medium, and long-range contingency plans that are in alignment with the overall strategic goals of Reynolds American Corporation, including hot site annual disaster recovery testing and related policies and procedures.
• Generation of test protocols for software testing and validation.
• Played an active role in the UAT and the release of CTMS integration project.
• Responsible for executing and developing compatibility validation tests.
• 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.
• Developed test scripts to ensure that the system is compliant with 21 CFR Part 11 and GMP regulations.
• Documented deviation reports and maintained deviation report log for tracking during OQ testing.
• Developed Performance Qualification (PQ) Test Plan and documented PQ test strategy and test scope.
• Participated in change control process meetings with business users and developers.
• Prepared test scripts for data base updates and audit trials.

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