SUMMARY:

Proactive Professional with extensive experience in quality assurance in pharmaceutical, manufacturing, and web publishing domain. Action oriented and results focused with expertise in project management, change management, team management, automated testing and system integration testing. Prepared and Delivered compelling executive level presentations by building consensus and persuading key stakeholders. Highly analytical with advanced communication and organizational skills.

CORE COMPETENCIES

• Clear and effective communications with the Sr. Program Managers, PMO, Development Managers and stakeholders. Manage Upstream/ Downstream Dependencies to keep current of the ongoing workload, milestone accomplishments, issues, risks and proposed mitigation strategies.
• Proficient in project planning, estimate consolidation, risk management, requirements analysis, systems design, testing methodologies and practices, and vendor management
• Production of conceptual, task - focused training and reference manuals for technical and non-technical audiences.
• Implementation Planning, post deployment support, and proper handoff to business users.
• Experienced in Waterfall, Agile, Scrum methodologies; Windows and Unix environments
• Prior experience in comprehensive scripting and test automation experience in all application environments: web based, mobile, and client server sectors.
• Issue Tracking using HP-ALM & RQM to facilitate resolution, and escalate critical issues to management.
• Developed and managed detailed project plans using MS Project

PROFESSIONAL EXPERIENCE:

Confidential, New Haven, CT

IT Validation Lead

Responsibilities:

• Developed and Reviewed Validation documents for system upgrade of SAP ECC 6.0 to EHP7 for compliance with GMP /FDA regulatory (21 CFR Part11) testing.
• Developed and Reviewed the IQ/ OQ/ PQ protocols for the upgrade plan. Developed various documents besides the Protocols necessary for validation process like development of: User Requirement Specifications, Functional Specifications, Design Specifications, Requirements gathering and Management, Risk Assessments for GAMP 4/5 systems. Validation Plans, Validation Summary Report, Business Continuity Plan, Validation Plan Summary, and Requirements Traceability Matrix.
• Review of Business Process Procedures, Configuration Management, Change Control, Incident Management,, SOPs, Code Review, Test Strategy/Plans/ScriptsManagement of Quality Documentation Process of Quality Document initiation, training and revisions, Change Management Process and Deviation and CAPA Management and Deviation Reporting.

Confidential

• Reviewed Validation test plan for validating the tool for compliance with GAMP 5 regulatory testing.
• Co-authored the OPQ protocols for the upgrade plan.
• Generated summary reports for OPQ, to describe the test execution.
• Developed various documents besides the Protocols necessary for validation process. Like - Admin SOP, User SOP, Business Continuity Plan, User access forms, Validation Plan Summary, Requirements Traceability Matrix.

Confidential, Florham Park, NJ

QA Team Lead

Responsibilities:

• Managed the strategic delivery of several technology led initiatives using Agile best practices, including daily scrum calls and maintaining backlog items.
• Successfully managed the migration of the testing artifacts from HP ALM to IBM RQM .
• Successfully implemented an application monitoring initiative in 5 months (a project that was in rework for over 1 year). The project increased participant eligibility base by 10%.
• Spearheaded program management for several complex automation projects. Created and implemented validation procedures that increased efficiency, accelerated customer satisfaction and slashed error rate.
• Conducted strategy meetings for the review and validation of the system data for compliance with GMP /FDA regulatory (21 CFR Part11) testing.
• Conducted weekly meetings for discovery, validation and deployment with all users at various stage gates of planning and deployment of devices at multiple BASF sites in North America.
• Responsible for deployment program management, liaised with the vendors and global team for resource management, implementation and post implementation responsibilities.
• Interfaced with vendors and the BASF purchasing teams to streamline the equipment ordering process.
• Generated data archival plan and developed architecture for storage of HP ALM for legacy GMP /FDA regulatory regression testing results.
• Coordinated the evaluation and installation of SAP TAO, Business Process Testing (BPT) and of Dashboard in Mercury Quality Center 9.0.
• Program management for conversion of Business Processes from Business Requirements to automated testscripts of Order-to-Cash and Purchase-to-Pay processes for regression testing of SAP functionality. Determined Entrance/Exit Criteria for functional testing with consultation of the stakeholders.

Senior Information Analyst

• Elicited, analyzed, communicated and validated requirements for changes to business processes, policies and systems.
• Collaborated with Operations, Development, and Production to validate the quality of systems upgrades for GMP /FDA regulatory (21 CFR Part11) compliance, during enhancements and production fixes.
• Generated and reported testing stats to management. Identified risks and proposed risk mitigation strategies. Created high-level work flow presentation to give an overview of solution design and implementation. Created use cases which depicted all the functions and scenarios to be tested.
• Oversaw and participated in the creation of detailed test scripts and test plans and the performance of Regression and UAT testing.
• Provided first level support for production issues for all applications across multiple platforms. Reported and tracked all issues using Quality Center.
• Provided training to end users to enable smooth rollout of product.
• Responsible for the migration of data, routine maintenance, and monitoring of test projects. Successfully managed the testing projects in Quality Center.
• Created Load/Stress testing requirements and strategy. Successfully performed load testing to evaluate improvements in response time from the benchmark.
• Developed specialized dashboard views for Business Managers, Application Owners, and support staff. Responsible for providing training and creating troubleshooting documents for different user groups.
• Developed and executed test strategy and scripting effort for performance testing of application using VPN client from several sites for the Sales Force Automation System Deployment.
• Executed regression testing before and after patching the application and database servers.
• As a application owner, managed the upgrade of HP ALM / Quality Center.

Information Analyst

• Responsible for project co-ordination with the business groups, development team, and QA. Maintained test plans, test cases, and defect tracking using HP Quality Center.
• Created automated test scripts using QTP (5.x and 6.x) for functional testing and system validation for GMP /FDA regulatory (21 CFR Part11) compliance.
• Generated and maintained automated regression test scripts for SAP R/3 transactions and other web based applications, using HP (Mercury) toolset (QTP and Quality Center).
• Successfully managed the development and implementation of the web portal for SAP Knowledge Center (Change Management System) .
• Received special recognition certificates from Management for going above and beyond for implementing the SAP Change Control procedure manual in compliance with GMP /FDA regulatory (21 CFR Part11) testing.

Confidential, Whitehouse Station, NJ

System Tester - Consultant

Responsibilities:

• Created Integration test plans in accordance with 21 CFR Part 11 guidelines for Procurement (Ariba EZ Buy), General Ledger - GL (JD Edwards), Property Accounting (CPM) and Foundation interfaces with MAXIMO software.
• Executed backend queries to test the population of tables in the host system
• Performed system integration testing with 21 CFR Part 11 guidelines applicable to the pharmaceutical industry
• Updated requirement specifications, design specifications and DLL requirements for core MAXIMO modification and upgrade with the various interfaces.
• Performed functional testing of modified MAXIMO application.
• Performed end-to-end Integration testing of procurement interface systems.
• Created Custom SQL query to test the integrity of database.

Confidential, South Plainfield, NJ

QA Tester

Responsibilities:

• Actively involved in requirement analysis, developing strategic, designing test plan, identifying test conditions, designing test cases, reviewing test cases, test scripts and executing test cases.
• Testing Web application.
• Executed software test plans. Reviewed software documentation to ensure completeness and risk reduction. Prioritized testing focuses. Designed scenarios and procedures.
• Tested system modifications for function and efficiency.
• Created tests to address negative testing and error/bug retests.
• Documented software errors using a bug tracking system. Reported bugs to software developers. Tracked bug resolution efforts and successes.
• Identified and analyze problems with online screen and content. Provided input on potential problems.
• Used operating systems software such as UNIX and VM Ware Workstation.