SUMMARY:

• Over 13 Years of Experience in Software Validation and Testing, Experienced in SAP R/3, SAP BW Testing and Implementation. Project Management and support for software and related business processes.
• Understanding of drug development process and working knowledge of FDA, GCP, GLP and GMP requirements.
• Understanding of the principles of computer System Validation.
• Experience in ISO 9001 Software Quality Assurance Methodologies, SEI CMM Models.
• Experience in execution of IQ/OQ/PQ protocols.
• Experience in Quality/Regulated environment and implementation of Quality Systems for software adhering to ISO 9000 standards.
• Implementation of quality systems in line with SDLC requirements and developing Validation Risk Assessment plan / Summary Reports.
• Participation in implementation of 21 CFR Part 11 - Electronic Record and Electronic Signature requirements, Security, Audit trail (user and date time stamps), Validation, Development Methodologies, Requirements, Design, Testing Methodologies in UT/IT/UAT phases.
• Participation in creation of SOPs, Validation Plans, and software inspection/audits.
• Development of requirement guidelines specification documents, design specification documents, project activities summary documents, trace ability/verification matrix, technical standards documents, Master validation plans for UT/IT/UAT test phases.

TECHNICAL SKILLS:

Operating System: Windows and UNIX.

Languages: SQL, SQL*Plus, HTML, XML, Java Script, ABAP and TSL

ERP: SAP and Oracle

Databases: Oracle 8.0, Sybase, SQL Server7.0 and MS Access

Development Tools: Visual Basic, Power builder and Developer2000.

Software Packages: MS Word, Excel, Power Point, Outlook, Frame maker, Internet Services (MSIE, Netscape, AOL, CompuServe).

Automated Test Tools: QTP, Quality Center, PVCS Tracker 6.0 & Continuus.

Hardware: Sparc Stations and IBM PC.

Internet Technologies: Internet Basics, HTML&Concepts of Networkings.

Others: SAP, SAS, E-Data Mgt, LMS-IBM / Kaplan, GCP, GMP, GLP, Oracle Clinical 4.0.

PROFESSIONAL EXPERIENCE:

Confidential,Morgantown,WV

SAP QA / Validation Lead

Responsibilities:

• Performed end to end validation process for One Mylan project (Blue print to Go-live)
• Developed validation Plan for One Mylan Project, CSV Risk Assessment, Summary reports and Traceability Matrix.
• Developed validation protocols based on SOP’s - IQ, OQ, PQ and PLPE.
• Created Disaster Recovery Plan / SOPs.
• Developed Test Scripts in SAP HR, CRM, QM, BW, MM, SD and FI/ Confidential modules.
• Interacted with Functional, Development Team to develop Test Scripts according to the requirements and Business Process Procedure.
• Validated BPP’s, URS and FRS as per GMP.
• Involved in Unit Test, Integration, Regression and UAT.
• Implemented RAD Methodology to perform testing.
• Using Master date to create data sets for test and validation process.
• Validated RICEF as per BPP specifications.
• Performed pre & post approval reviews for SAP test scripts.
• Conducted data validation and verification.
• Reported the defects in HP Quality Center and involved in Regression Testing.
• Conducted Audit trails - 21 CFR part 11 for GMP.
• Involved in Test script development and data validations.
• Validated data and BW reports as per audit requirements.
• Used SAP solution Manager and Documentum for document management.
• Tested Reports, interfaces, Conversions, Enhancements and Forms.
• Worked closely with Functional, Development Team to solve the defects reported in Test Director.
• Validated QTP for test automation.

Environment: ECC 6.0, Oracle, UNIX-AIX, Windows, Documentum 7.0, IQ, OQ, PQ, GxP, HP Quality Center and QTP.

Confidential, Piscataway, NJ

BA / Sr.Validation Consultant

Responsibilities:

• Worked as a Validation Consultant for HP Test Automation Tool Project.
• Created Project Charter, Compliance Analysis, Compliance Plan, Risk Assessment and Compliance Summary report.
• Guidance provided to Project team members to develop Project Management Plan, Functional specification, Technical specification, Test plan and scripts.
• Review performed on all project documents and testing.
• Created and Validated Standard Operating Procedures.
• Created Business requirement for HP Tool Validation project.
• Validated HP Test Automation Tool Work flow.
• Validated URS, CFS, FDS and TDS as pre J&J Compliance standards.
• Generated Project / Validation Status reports.
• Validated Test cases in HP Quality center 9.2.
• Prepared validation summary and Protocol execution summary reports

Environment: HP Quality Center 9.2 and 10.0, HP QTP 10.0, SharePoint, Testing, Validation, Windows.

Confidential,Saginaw, MI

SAP Test / Validation Consultant

• They implemented SAP ECC for their ERP operations. My role here is to lead SAP QA Validation Team and coordinate testing and Validation process for Chauny Upgrade project (from 4.7 to 6.0).
• Developed overall Test strategy and VMP for Chauny upgrade project
• Performed Manual Testing in FI and PP-QM Modules.
• Implemented Quality Center for Upgrade Project
• Reviewed and developed Test cases for SCM, OTC and QM Modules.
• Validated all components of the Manufacturing Execution Systems (MES) - Traceability and genealogy, Overall Equipment Effectiveness, Process visualization, and Data historians
• Developed test and validation documents as per cGAMP compliance.
• Closely working with SOX / Audit team.
• Created Gap analysis and Risk assessment documents.
• Working with SMEs and remote/offshore teams.
• Working on Sol Man to maintain Project and Test documentation.
• Responsible to created Traceability matrix, Data Migration summary report, IQ, DQ, OQ and PQ protocols.

Environment: SAP ECC6.0, MES - SYNCADE, SharePoint, Sol Man, Quality Center, Testing, Validation, Windows.

Confidential,Plainsboro, NJ

BA / SAP Validation Consultant

• Successfully completed online training courses in BMS specific SDLC methodologies.
• Involving as a Validation Analyst for the SAP- RICEF Projects.
• Reviewing the System Requirement Specification (SRS), Design Specification (DS), and other project related documents for the SAP- RICEF Projects.
• Involving in Reviewing Requirements Traceability Matrix, and assisted in the compilation of a Business Process Master List (BPML).
• Coordinating closure of all open defects during various Phase of testing.
• Performing pre-approval QA review and approved executed test strings in HP Quality Center to
• Follow SOPs and industry best practices
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
• Review validation deliverables for projects which are contracted to third party suppliers
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing
• Prepare computerized systems documentation such as Validation Plan, CSV Risk Assessment, Test Plans, Test Summary Reports, Test Scripts, Traceability Matrix, Validation Summary Reports
• Review Pre and Post executed test scripts.
• Provide guidance on quality issues that affect the integrity of the data or the system
• Obtain and draft responses to QA review.
• Assess compliance practices and draft recommendations for corrective action
• Maintain a working knowledge and awareness of regulatory requirements
• Organize validation documentation and prepare for archival
• Successfully complete testing phase of the SDLC workflow.
• Responsible for reviewing the executed test scripts for completeness, including the supporting documentation, and determining whether or not the test objectives were met.
• Involving in execution, post execution review and documentation of System/UAT Testing.
• Preparing Guideline for Pre-Approvals, Post Approvals and Defects
• Meeting with Functional and technical team to point out deficiencies in requirements and ways to cover it.
• Documented problems found during test using in HP Quality Center and communicated recorded problems to the responsible development personnel.

Environment: SAP ECC6.0, SharePoint, SolMan, LMS-Kaplan, Quality Center, Testing, Validation, Windows.

Confidential,Gaithersburg, MD

SAP Validation / Test Consultant

• They implemented SAP R/3 for their ERP operations.
• Worked as a SAP Validation Consultant for Flu Mist International (International shipping project for H1N1).
• Generated Master Validated Plan, Risk Assessment for FluMist International shipping project - South Korea.
• Developed Test Plans for FluMist International.
• Validated SAP Cutover and Data Migration plans.
• Worked on SAP SD, MM and FI/ Confidential Modules.
• Created / Updated Test protocols for Order to Cash Project.
• Validated URS and TRS as pre cGMP.
• Executed OQP’s for FluMist International Project
• Prepared validation summary and Protocol execution summary reports

Environment: SAP ECC6.0, MES, Doc-Compliance, Quality Center, Testing, Validation, Windows.

Confidential,Lebanon, NJ

SAP HtR Security Tester

Responsibilities:

• Developed Security Test cases for HtR Project
• Created Security Test cases for R/3 and BI
• Executed security testing for ECC and Portal.
• Reported Test Incidents and Generated Status Report.
• Crested Security Test cases for HtR Project by using Quality Center.

Environment: SAP R/3, BI, Windows and Quality Center.

Confidential,Morgantown, WV

BA / Sr. SAP Validation / Tester

• Developed validation Plan, CSV Risk Assessment, Summary reports and Traceability Matrix.
• Developed validation protocols based on SOP’s - IQ, OQ, PQ and PLPE.
• Created Disaster Recovery Plan / SOPs.
• Worked as a Business Analyst to create / Validate requirements.
• Developed Test Scripts in SAP HR, CRM, QM, BW, MM, SD and FI/ Confidential modules.
• Interacted with Functional, Development Team to develop Test Scripts according to the requirements and Business Process Procedure.
• Validated BPP’s, URS and FRS as per GMP.
• Involved in Unit Test, Integration, Regression and UAT.
• Tested customer defined Info types.
• Validated RICEF as per BPP specifications.
• Worked on Prod support / Help desk support for Validated environments.
• Conducted data validation and verification.
• Conducted Audit trails - 21 CFR part 11 for GMP.
• Validated BW reports as per audit requirements.
• Used SAP solution Manager for document management.
• Tested Reports, interfaces, Conversions, Enhancements and Forms.
• Worked closely with Functional, Development Team to solve the defects reported in Test Director.

Environment: SAP R/3, ABAP/4, Oracle 8i, UNIX-AIX, Windows 2000, IQ, OQ, PQ, GxP, Quality Center.

Confidential

QA Tester / Validation Consultant

Responsibilities:

• Involved in creating test plan, test scripts, test summary reports, validation summary reports for various data classes/Modules using requirements derived from GRADES which is a set of clinical data standards and processes that will cover all data in all clinical trials.
• Tested and validated various SAS Algorithms(Macros) by generating report tables for Summary, listing and Graphs for inclusion in Clinical Study reports and regulatory submissions in accordance with FDA regulations particularly 21 CFR Part 11.
• Verified SAS logs for successful execution of Macros and report errors using UIMS system.
• Updated Metadata Parameters for various SAS Macros and tested them with different permutations of variables.
• Extracted data from Oracle Clinical and created portal datasets to create reports for various Clinical Trails and Protocols.
• Coordinated backend testing using SQL queries and performed Manual testing on the PL/SQL scripts using TOAD scripts.
• Documented and validated all aspects of the computer validation system development lifecycle using Live Link, in accordance with FDA regulations particularly 21 CFR Part 11, validation planed protocol, installation qualification (IQ) specification, operation qualification (OQ) specification, performance qualification (PQ) specification and validation Summary Report.
• Defined and followed Standard Operating Procedures (SOPs) and validated if the software development is according to the current Good Manufacturing Practices (cGMPs).
• Documented accurate and complete records in both human-readable and electronic form for FDA to inspect review and copy the records.
• Participated in the team meetings and walkthroughs, interacted with the other development team members to better understand system functionality in order to improve testing quality.

Environment: Oracle Clinical, SAS Macros, PL/SQL, Java, Oracle 9i, Windows 2000, Manual testing, Unix, Test director.

Confidential,Princeton, NJ

SAP Test Consultant.

• Worked as Test Consultant for SAP 4.6c support packs upgrade project.
• Validated Test cases as per GMP
• Worked on Support Pack related business process integration/regression Testing and Project management.
• Regression Testing and Integration Testing was done different modules like SD, MM, WM/IM Test Scripts.

Environment: SAP R/3, Documentum, Testing, Validation, Windows.

Confidential,Carona, CA

SAP Validation / Test Consultant

• Writing and execution of test plans, protocols, and test scripts adherence to Standard Operating Procedures and Corporate Policies relating to software validation and Coordination of testing and validation activities
• Completed Validation and testing on HR, SD, SCM, PP and MM modules.
• Participated in quality aspects of developing standard document templates for validation deliverables like Validation Plan document, User Requirements
• Developed test scripts for OQTP using Test Director.
• Involved in preparing Functional Specification document, System Design Specification document, Master Test Plan, Product Deployment request documents.
• Involved in preparing draft SOPs and Process Guides required for URS, FRS and CFS on SAP Application.
• Writing and execution of system test plans and scripts and coordinated with users in the development of acceptance test plans and scripts.
• Writing and execution of test scripts (IQ, OQ, PQ, and Unit Tests) accordance with standards, and summarizing test results,
• Very good experience in validation as per FDA Guide lines and cGMP practices.
• Writing and execution of Installation/Operational/ Qualifications, Performance Qualifications and 21-CFR-Part-11 compliance of Electronic records and Electronic signatures with security validations.
• Prepared Master Validation plans, Generated SOPs for Validation Process. Reviewed and edited new and revised SOPs.
• Ensuring ongoing quality management of clinical trial data according to Good Clinical Practice/ICH guidelines.
• Participation in Development of Master Test Plans, Test Validation Methods for UT/IT / UAT process, Generation of SOPs, planned and implementation of 21 CFR Part 11 Electronic Record, Quality Audits, inspections and facilitated the implementation of quality systems in line with SDLC requirements.
• Info Queries were tested to get reporting data from SAP BW.
• Data Targets and Info Objects in SAP BW are located for scheduling and Monitoring.
• Regression Testing and Integration Testing was done different modules like HR, MM, PP and SCM Test Scripts.

Environment: SAP R/3, SAP BW, ABAP/4, BEX Analyzer, Administration Work benchValidation, 21 CFR 11, IQ, OQ, GMP, SOP, cGMP, Oracle 8i, Sun UNIX 11.0, Windows NT 4.

Confidential,Indianapolis,IN

SAP Validation / Test Consultant

• Very good exp. in validation and cGMP practices.
• Developed Test Scripts for SAP BW by using Test Director.
• Test Scripts, Test Cases and Test sets were developed for testing process.
• Manual testing was done on different modules like HR, SD, SCM, PP and MM.
• Data was loaded from SAP R/3 to SAP BW database.
• Developed validation Plan, CSV Risk Assessment, Summary reports and Traceability Matrix.
• Info packages for different modules are scheduled.
• Documentum was used for the version control of the documents.
• Well versed with Check-in and Check-out of the documents.
• Well experienced in setting up attributes for the documents.
• Writing and execution of test scripts (IQ, OQ, PQ, and Unit Tests) accordance with standards, and summarizing test results.
• Prepared Master Validation plans, Generated SOPs for Validation Process. Reviewed and edited new and revised SOPs.
• Participated in implementing the 21-CFR-Part 11 compliance standards.
• Attributes for the different Info Object are compared in SAP R/3 and SAP BW.
• Info Queries were tested to get reporting data from SAP BW.
• Data Targets and Info Objects in SAP BW are located for scheduling and Monitoring.

Environment: SAP R/3, SAP BW 3.2, CRM, SM, ABAP/4, BEX Analyzer, Administration Work bench, Oracle 8i, Documentum 4.0, Sun UNIX 11.0, Windows NT 4., Win Runner, Quick Test and Test Director.

Confidential,Piscataway, NJ

QA, Lead Tester

• Confidential is one of the Packet Services Suite systems that enable a service provider to offer local and long distance telecommunications services over an Internet Protocol (IP) network. Confidential is the control center for supporting IP Telephony. It maintains trunk and line information, maintains Call State during the duration of a call and implements user features as appropriate.
• Provide lead software testing functionality for the IGCS software development team.
• Duties include driving the MUT and regression test teams and coordinating with environment support to provide stable test environments.

Environment: Emulator, INET, SS7, ISUP, TCP/IP, FTP, PPP, GTP, SGCP, OSS, NGN, VOIP VPN, UNIX, NT and Telnet.