SUMMARY:

• Results - driven Business Technology executive with over 18 years of business experience including 12 years of IT experience related to operational compliance within a highly regulated industry.
• Over nine years of Global Supply Chain Management experience with Third party logistics (3PL) companies. Managed an office with responsibilities for business forecasting, client and business development, customer service, Supply chain improvement, operational compliance planning, and P&L.
• Supply chain management and vendor coordination for International buying houses for their Global Sourcing Operations from Forecast to Order and Production to Delivery processes. Implemented the Best practices of Collaboration, Groupage, JIT, synchronizing inbound and out bound Logistics to increase the profitability of the Buying houses.
• Experienced Professional with Supply Chain processes and systems as well as involvement in Business Process improvement /Change Management consulting and implementation. Identifies issues, and defines actions and solutions to significantly improve results.
• Highly motivated with solid experience in implementing/managing quality assurance program for CRM, Analytics and ERP solutions across various Life Science industries. Worked on Reports, Dashboards, score cards and Descriptive analytics to report performance management to Corporate management.
• Ensured the developed and deployed solution meets the end requirements and Quality standards.
• Used test tools for test tracking, defect management, and test automation.
• Prepared and reviewed documents for test strategy, risk analysis, gap analysis and test summary reports.
• Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation.
• Lead and Participated in test planning, test case creation, analysis and implementation for Sanity testing, Installation testing, Front-End testing, Back-End testing, Integration testing, Full-Cycle testing, regression testing, Data-Migration testing and end user acceptance testing (UAT).
• Conducted daily and weekly team meetings and updated the status and test metrics to project management.
• Excellent team player and able to work effectively at all levels of an organization with the ability to influence others to move toward consensus

IT TOOLS SKILLS:

ERP environment: SAP (HANA, ECC, SCM, PTP, OTC, CRM, BI, BTB, MDM) CARS, Oracle JDE E1 and Baan.

Software Development Tools: Quality Center, JIRA, Rational tools and Visual SourceSafe.

MS Technologies: .NET, PowerPoint, Word, Excel, Microsoft Project.

Others: PDMA, 21 CFR Part 11, DQSA(DSCSA), Computer system validation, SDLC, Oracle, SQL, Data stage, ODS, Data Mart, Informatica, EDI, QlikView, MARC, Analytics, jupyter and FDA compliance.

PROFESSIONAL EXPERIENCE:

Confidential

SAP Integration Test Lead

Responsibilities:

• Consulting as Integration Test Lead forE2E Supply Chain PMO of DePuy Synthes Rainbow Variant configuration Global Program.
• Coordinating and conducting Business Simulation Testing and User acceptance testing with business users for Variant configuration.
• Responsible for test plans, test scripts, test execution, defect tracking & triage
• Developed comprehensive process to Identify, document, mitigate and Report the Risks/Issues with regards to testing (execution, preparation, test data management, approvals...) on timely manner
• Escalate to appropriate teams and leadership to resolve
• Define, track, and report metrics to measure testing progress and quality

Technical Environment: SAPAPO, MDM, MDG, Back to Basics, OTC, Lynx, JDE, MARC and other legacy applications) HPALM and JIRA.

Confidential

SAP Integration Test Lead

Responsibilities:

• Engaged with clients to analyze business requirements, Prepared test strategy, test requirements and acceptance criteria documents, Creating Test Estimation, Test Scenario Preparation, Test execution, Tracking and reporting defects
• Mentoring team and managing their deliverables, Maintain the Requirement Traceability Matrix (RTM)
• Creating Test summary report

Technical Environment: SAP (PTP, RTR, BPC, OTC S4 HANA), Peoplesoft, HP QC, Global Data Warehouse

Confidential

System Integration Test Lead

Responsibilities:

• analyze business requirements, prepared test strategy, test requirements and acceptance criteria documents
• Creating Test Estimation, Test Scenario Preparation, Involved in Test execution, Tracking and reporting defects
• Mentoring team and managing their deliverables, Maintain the Requirement Traceability Matrix (RTM)
• Creating Test summary report

Technical Environment: Salesforce, JDE, HP QC, Enterprise Data Warehouse, 3 PL

Confidential

Testing consultant

Responsibilities:

• involved in test Planning, test development, test management and test reporting activities.

Technical Environment: Informatica, DB2, Teradata SQL Assistant, JIRA.

Confidential

SAP Integration Test Lead

Responsibilities:

• Engaged with clients to analyse business requirements, Prepared test strategy, test requirements and acceptance criteria documents, Creating Test Estimation, Test Scenario Preparation
• Involved in Test execution, Tracking and reporting defects, mentoring team and managing their deliverables
• Maintain the Requirement Traceability Matrix (RTM), Creating Test summary report

Technical Environment: SAP HR, ECM, HP QC, Equity compensation Manager, Global Data Warehouse

Confidential

Validation consultant

Responsibilities:

• Participated in Mapping out the business process.
• Assisted in developing business documentation (SOPs, Work Instructions, Process controls, Risk Maps) and business process maps
• Preparing and reviewing IQ, OQ and PQ documentation for Regulated application DEA/FDA/HIPAA areas using Rational tools.

Confidential

Validation consultant

Responsibilities:

• Participated in Mapping out the business process (Manufacturing, Distribution Center operations, transportation to Wholesaler, Retailer, EDI, ASN, Work flows and data flows for OTC and P2P .
• Assisted in developing business documentation (Business Requirements, SOPs, Work Instructions, Process controls, Risk Maps) and business process maps
• Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation for Regulated application suspicious order management and DEA/FDA regulated areas.
• Participated in evaluating software package that uses global manufacturing and distribution center data to identify and track products from the manufacturer to the wholesaler and retail customer in concordance with proposed regulations
• Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory compliance needs.

Confidential

System Tester

Responsibilities:

• Supported the implementation of business processes to ensure GSK is compliant with legislative requirements of the Federal Drug Supply Chain Security Act by testing the business processes thru the order management system.
• Assisted in developing business documentation (Business Requirements, SOPs, Work Instructions, Process controls, Risk Maps) and business process maps.
• Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation
• Developed testing plans (UAT, Regression, and Defect Management) for quarterly scheduled Order Management System IT builds for DSCSA compliance. Participated in defect triages, status meetings and updated management about the status.
• Communicating the customers and stake holders about DQSA impact to order cycle time.
• Maintaining DQSA reporting capabilities, Monitor KPI’s, Process root cause analysis and monthly auditing requirements
• Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory needs.
• Participating in GS1 Rx Secure Supply Chain discussions and HDMA Traceability Group calls, Third Party Solution Provider webinars and continue to ensure GSK’s T&T Strategy is aligned to larger pharmaceutical industry. Summary will be updated to T&T Manager about the upcoming trends in the trade.

IT Environment: JD Edwards, CARS, DCMS, EDI ASN 856, DQSA, Quality Center and Rational tools

Confidential

Test Lead

Responsibilities:

• Developed Test strategy, SOPs, test requirements and acceptance criteria documents.
• Resource planning Use case preparation, training testers and offshore team management.
• Conduct functional testing, integration testing, and data migration testing.
• Coordinated User Acceptance Testing to ensure that the SFA and SAP applications meet the end customers day today needs.
• Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation for regulatory compliance

IT Environment: SAP ECC6.0, SFA, Quality Center, Analytics.

Confidential

System Tester

Responsibilities:

• Participated in Mapping out the business process (Manufacturing, UID generation, Distribution Center operations, transportation to Wholesaler, Retailer, EDI, ASN, E Pedigree) Work flows and data flows for product serialization.
• Participated in evaluating software package that uses global manufacturing and distribution center data to identify and track serialized pharmaceutical products from the manufacturer to the whole saler and retail customer in concordance with proposed regulations
• Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory compliance needs.
• Participated in GS1 Rx Secure Supply Chain discussions and HDMA Traceability Group calls, Third Party Solution Provider webinars. Summary updated to T&T Manager about the upcoming trends in the trade.

IT Environment: JD Edwards, EDI, DQSA, Quality Center, E Pedigree, Track and Trace and Rational toolsl

Confidential

Test Lead

Responsibilities:

• Developed Test strategy, SOPs, test requirements and acceptance criteria documents.
• Resource planning Use case preparation, training testers and offshore team management.
• Conduct functional testing, integration testing, and data migration testing.
• Coordinated User Acceptance Testing to ensure that the SFA and SAP applications meet the end customers day today needs.
• Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation in compliance with CMMI

IT Environment: SAP ECC6.0, SFA, Quality Center and Share point.

Confidential

Project Lead

Responsibilities:

• Reviewed and updated Test strategy, SOPs and acceptance criteria documents.
• Reviewed and updated test cases in Quality center (HP QC) and created traceability matrix.
• Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation.
• Collaborated with members solution development team and other stakeholders in ensuring timely delivery of deliverables
• Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation in compliance with CMMI

IT Environment: Metis, Rational tools, JIRA, PL/SQL, Cognos, IIS, Visual Studio, Manhattan Associates

Confidential

Quality Lead

Responsibilities:

• Monitoring and coordinating projects from initiation through delivery with test teams in US and Offshore location to keep projects on schedule and within budget.
• Lead System testing, Integration Testing, End to End Testing and User Acceptance Testing activities to ensure that the SFA,SAP and MDM applications meets the end customers day today needs.
• Schedule/Time management in order to reach deliverables on time and within budget.
• Develop, implement and enforce SOP and work instructions as per Good Documentation Practices in compliance with CMMI.

Environment: Master Data Management, Rational tools, Quality Center10.0, JIRA, Data Analytics and PL/SQL.