SUMMARY

• Over 11+ 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
• Conceptualized SharePoint Farm Attributes and SharePoint Site Collections
• 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.
• Solid Knowledge on Regulatory Processes (FDA - 21 CFR Part 11, GxP Validation and compliance audit)
• Extensive experience with Pharmacovigilance 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
• Experienced in Requirements gathering, SharePoint solution recommendation to the customers.
• Experience in Salesforce implementation Apex Classes, Triggers and Visual Force Pages, Salesforce Lightning Design System and Lightning App Builder, lightning components bundle.
• Experience in SAP TM, SD and CRM modules with integration to FI and MM modules.
• In-depth Upgrade & Implementation experience in various Oracle Cloud ERP Release 9,10, 11, 12, 13 Versions.
• 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.
• Experience in different SDLC methodologies like Agile/Scrum, Waterfall, RUP and V Methodology.
• Strong SQL Server 2005 skills to build optimal database structure. Familiarity with TOAD. Knowledge of Relational Databases, Data Warehousing. ETL concepts.
• Regulatory compliance professional experience in GXP(GMP, GCP, GLP, and GAMP).
• 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 with cloud marketing, sales (CRM Salesforce), Wave Analytics, Discovery, quote to cash C2C,and CPQ.
• 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.
• 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.
• 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.
• Performed Data mapping in XML and performed data analysis with SQL Queries.
• System Expertise: Drug Safety Pharmacovigilance, CAPA, clinical, CRM, DAM, dashboard, EDM, ERP, ETL, event tracking, infrastructure, MDM, MRM, SFA Professional Experience.

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 Configuration, Bi-Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in client’s LIMS system.
• Directed the clinical trial data capture and worldwide data collection systems for various therapeutic areas,also worked on data quality and data catalogue.
• Did complex data analysis, data mapping, and data validation for EDW project & also conducted Regression Testing/SIT/UAT.
• Worked in the start-up which developed IoT platform for Smart Lighting Control & Data Analytics Products
• Created and maintained comprehensive test plans and test specifications through SharePoint
• Created custom enhanced reports in ALM and using complex SQL queries and Business Views
• Executed IQ, OQ and PQ testing protocols for Labware LIMS.
• Responsible for initial and thereafter annual training for all employees for cGMP(21 CFR Parts 210, 211 and 820), cGLP (21 CFR Part 58).
• Creation and maintenance of reports to support the business in Salesforce .
• Served as the pharmacovigilance subject matter expert.
• 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.
• Substantial experience in Sanity and Smoke Testing of applications before testing effort of UAT and Regression Testing of applications.
• 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.
• Provided SharePoint best practices and advice regarding site set-up, site security, maintenance, and future needs.
• 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.
• Act as first point of contact for business stakeholders in the US to support MDMimplementations and provide guidance, advice, and support.
• Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines
• Built multiple modules using MuleSoft ESB which has integration with Salesforce.
• 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).
• Wrote Test cases and Conducted different integration and regression testing. Involved with UAT team in user acceptance testing.
• Starting up a new IoT team to help support the network needed to run IoT products
• Worked in Scrum/Agile methodology and created/prioritized product backlog items for MITA & EDW
• Defect identification and reporting through HP ALM QC
• Developed a quick and thorough understanding of MS SharePoint 2010.
• 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.
• Reviewed all completed IQs/OQs, checklists, and other documents for accuracy and compliance with GxP and FDA rules and regulations
• 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.
• Creating Lightning Components and used Salesforce SLDS to convert existing Visualforce pages to lightning components.
• Provide technical leadership for the development and integration of new IoT technologies and systems
• Experienced in Working closely with Project Managers to understand UAT resource requirements from the business
• Performed match/merge and ran match rules to check the effectiveness of MDM process on data.
• 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, Pharmacovigilance Plans and Risk Minimization Plans.
• Performed quality assurance testing on developed SharePoint sites and web parts
• 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.
• Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance.
• Managed regulatory compliance and quality assurance within the guidelines of FDA 21 CFR part 11 documentation.
• Evaluate and prototype innovative technologies and concepts with IoT and related technologies.
• Implemented and customized Salesforce customer relationship management (CRM) for Marketing, Sales and Case Management also implemented sales cloud and service cloud to improve customer retention and service delivery process improvement.
• Captured detailed BRD/FRD for ICD-10 & conducted testing: SIT/UAT: Test-Plan development/Test-Cases development/Test-Data creation etc.
• Contribute to safety and pharmacovigilance training programs.
• Conducted Gap Analysis to demonstrate that LIMS System remains in a validated state in its life cycle.
• Develop a strategy for the design for IoT technologies and systems
• Prepared Traceability Matrix to keep track of relationship between all requirements and test scripts.
• Prepared Qualification Reports to qualify Barcode printers in manufacturing process

Environment: J2EE, SQL Server, XML, HL7, UML, Oracle, MS Visio, MS Office, MS Project, Filenet.

Confidential

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.
• Compliance with federal regulations, including 45 CFR 46, 21 CFR 11, 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.
• Conducted UAT of application along with end users before it is incorporated into complete suite.
• Created quotes on the Salesforce platform with CPQ software for client requirement.
• Responsible for Reviews, edits and formats all GxP Audit reports.
• Planned and created SharePoint 2007 and SharePoint 2010 Workflows.
• 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).
• Created a technical Specification document to show how the project gathered data to create a new system environment in Oracle.
• 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.
• Design, develop and implement solutions for the Salesforce/Apttus CPQ/CLM system deployed on the Salesforce platform.
• Prepared UAT test artifacts (Test Plans, Test Scripts, Traceability Matrices, etc.)
• 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.
• Upgraded projects from ALM 12.01 to 12.55.
• Standardized ALM workflow across the organization defining templates.
• 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
• Standardized ALM roles to restrict user access.
• Excellent track record for meeting deadlines and submitting deliverables on time using AGILE/SCRUM methodology.
• Designed training plans and develop a SharePoint curriculum to train customers on SharePoint functionality and encourage self-sufficiency
• Conducted meeting with Clinical, Biotech and Pharma experts for gathering current requirements and future goals.
• Conducted daily UAT defect tracking meeting to get the resolution timeline of defects.
• Created and documented Salesforce application requirements by working with end users and key stakeholders.
• 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
• 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.
• 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
• Worked with Thermo team in developing Design Specification document.
• Designed and authored validation protocols for LIMS application.
• Well experienced with VisualForce, APEX, Force.com platform, Triggers, Components and Controllers in Salesforce Classic &Lightning.
• 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.
• Was responsible for onsite visits and making SharePoint solutions recommendations to the clients
• 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.
• 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.
• 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.
• Working on change management with end-users related to new capabilities being developed or on-going changes to the Salesforce platform
• Consulted and assisted with FDA content development and compliance regarding pharmacovigilance adverse events and clinical medical claims and content.
• Worked closely with Thermo team in producing and executing all required documents.
• Created and tracked deviations occurred during testing process.
• Oversight and execution of a risk based GXP Supplier and Partner management program including Pharmacovigilance and IT software / software as a service (SaaS) providers.
• Worked and supported the Oracle ERP applications R12 & 11i on oracle 12C databases.
• Reviewed IQ/OQ/PQ’s for client requirements.
• Involved in analyzing system specifications, design and development of test plans.
• Reviewed validation / compliance requirements for SOX and GxP servers with site managers
• 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.
• Performed under Regulatory Compliance (GxP, FDA/GLP).
• Leveraged Agile development process to design SharePoint resources
• Involved in integration of Salesforce/ Apttus CPQ/CLM with third-party domain using web services
• Assisted in securing necessary drug and non-drug supplies for clinical trials and processed site requests.
• Worked on troubleshooting and resolving MDM related issues, and provide proven solutions aligning with master data strategies and best practices.
• Exposure in profiling data, defining metrics, building reports, dashboards & scorecards and visual analytics to support MDM and Data Governance initiatives.
• Interfaced with Business Owners and departmental Quality Assurance organization to ensure that all documents satisfied GxP and FDA requirements.
• Utilized full life cycle implementations, upgrades and extensions of Oracle EBS 11i/R12 and Oracle Cloud ERP.
• Involvement in documentation/execution of test cases. Analyzing the test results, resolving and managing discrepancies/defect using " HP ALM"
• Created Ad-hoc reports using SAP business objects and reporting requirements for canned reports.
• Identified, developed and executed Test Cases Manually.
• Involved in conducting stress test and volume test against the application.
• Coordinate the gathering and reconciliation of detailed business requirements and systems requirements for system development within an agile development model.
• Supported Case Management team with all pharmacovigilance activities associated with Individual Case Safety Report (ICSR) processing and reporting of adverse events in accordance with local regulations and company procedures.
• Gather, design, and implement requirements for Simmons Bank nCino loan origination system on the Salesforce Platform
• 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.
• Worked on ETLDesign and ETL development in Data Warehousing using Informatica Power Center.
• Perform data profiling and source to target mappings (while capturing ETL and business metadata) for populating Kimball style dimensional models.
• Designed the ETL mappings between sources to operational staging targets, then to the data warehouse using Power center Designer.
• Processed multiple PBM/ Pharmacy claims using QS1 pharmacy system in order to obtain a more efficient process of increasing claim reimbursement.
• Managed and supported Salesforce integrated applications related to field services, licensing, customer support.
• Excellent skills in in Analysis, Design, Development and Implementation of Enterprise Information Management solutions using Informatica Master Data Management (MDM), BusinessIntelligence and Data Integration applications.
• 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.
• Manage, and execute on Salesforce configuration projects of varying complexity to ensure the smooth operation of our day-to-day function.
• Prepared or assisted in the preparation of clinical trial agreements and budget payment schedules
• Managed administrative support for the clinical project management teams.
• 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, Oracle ERP, IMS, HP ALM, Quality Center, EMC Documentum, .Net, HTML, XML, 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.
• 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.
• Customization of Apttus product by using Salesforce features like triggers, VF pages.
• Responsible for reviewing and developing Drug Safety/Pharmacovigilance SOPs and Word Instructions.
• Ensured that day-to-day Pharmacovigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
• Performed extensive research into business strategies for establishing an independent PBM and working directly with more established PBMs in the process.
• Worked on data cleansing and standardization using the cleanse functions in Informatica MDM.
• Provide architectural design and create solutions for the customers to showcase the functionality of Informatica Master Data Management (MDM) and other products integrated with the MDM hub.
• Involve in designing MDM data model and created base objects, mappings, defined trust setting for sources, customized user exists, customized IDD applications.
• Handle daily maintenance tasks associated with Salesforce.com
• Used translator vendor tools to convert files into XML formats for successful processing.
• Analyzed & validated acceptance criteria are documented for user stories on multiple projects in AGILE.
• 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.
• Used Informatica Power Connect for SAP to pull data from SAP R/3.
• 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.
• Project Management, including analyzing business requirements, designing, testing, implementing of solutions, and documentation for salesforce lighting.
• Developed and maintain pharmacovigilance related SOPs, policies and work instructions.
• 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.
• Proficient in implementing methodologies such as Agile and Waterfall while working in the Software Development Life Cycle (SDLC)Perform complex program analysis - evaluate, recommend and plan actions to create processes to integrate the business analyst role into the welfare automated systems Agile (Scrum) development process.
• 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.
• Worked on various Salesforce.com standard objects.
• 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.
• Generation of test protocols for software testing and validation.
• Responsible for executing and developing compatibility validation tests.
• Involved in enterprise Service Cloud implementation using Salesforce
• 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, Oracle ERP, GEMS, HP ALM, Quality Center, 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.