SUMMARY OF QUALIFICATIONS

• Over 8 years of experience in Information Technology as QA/ Compliance/ Validation Analyst with experience in validating computer applications including Engineering tools, SAP ECC 6.0, Laboratory Information Management System (LIMS), Medical Devices, and Lab Instruments in regulated companies in accordance with 21 CFR Part 11 and GxP regulations.
• Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ).
• Experienced as QA Lead in guiding the team in delivering validation deliverables.
• Experience in reviewing and writing Master Test Plan and detailed Test Cases Formulation and involved in Regression Testing and Performance Testing.
• Ability to work well independently and in a team environment.

Validation/QA Expertise:

• Expert level of knowledge and good understanding of SDLC and validation methodology.
• Expert in reviewing and approving validation documents in accordance with company policies and procedures.
• Guided the team in implementation of SAP, LIMS and multiple in-house applications.
• Qualification of Infrastructure components according to company standards and SOPs.
• Validation of SAP ECC 6.0 system including Manufacturing, Procure to Pay, Warehouse Management and Order Management.
• Validate the data migration process for Customer Master, Material Master and Item Master to convert the data from legacy systems into SAP.
• Develop Requirement Traceability Matrix (RTM).
• Review Validation Plans, Test Plans, Test Summary Reports, Validation Summary Reports.
• Develop SOPs for Change Control and Security for SAP system.
• Review and Approve Use Cases, Test Plans, Test Scripts and Test Metrics.
• Develop validation deliverables for various software applications.
• Create, Review and execute IQ/OQ/PQ.
• Conduct Gap Analysis, Change Control, Part 11 Assessment, and GxP Assessment.
• Good knowledge of 21 CFR Part11, Predicate Rules, concepts of validation.
• Good knowledge of 21 CFR 820, 21 CFR 812, 21 CFR 606 and 21 CFR 640.
• Experience in Agile and SDLC methodology.
• Good knowledge on business rules.

TECHNICAL SKILLS

Languages: C, C++, JAVA, SQL, PL/SQL
Operating Systems: UNIX, MS DOS, and Windows 95/98/2000/NT.
Network OS: Novell NetWare 4.1, Windows 95/98/2000/NT.
RDBMS: Oracle 8.1/10g, SQL Server 6.5, SQL*Plus, DB2, TOAD
Applications/Servers: Engineering tools, SAP ECC 6.0, LIMS, Documentum, Mercury Quality Center, Tomcat, Weblogic and Websphere
CRM: Siebel
Office Tools: MS-Office, MS-Word, MS-Excel, Power Point and MS-Access2000
Others: MS Visio, MS Project.

EXPERIENCE

Confidential IL
Duration: Dec’11 to till date Validation Lead

Responsibilities:

• Involved in reviewing existing validated documentation (Siebel applications) and evaluated executed changes controls, reported problems, and vendor upgrades/patches in order to determine if any actions are requires such as upgrading, replacement.
• Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology.
• Daily conducted scrum meetings with Developers team and QSR (Quality System Representative).
• Participated in regular project meetings.
• Prepared Operational Qualification (OQ) test scripts for Internal Inspection Checklist for DaRT tool (Data Recording Tracking tool).
• Reviewed and routed all validation documents using BPLM (Baxter Product Lifecycle Management) for Team review.
• Worked closely with Development Team to identify the test scenarios and test cases.

Confidential VA
Duration: Sep’10 to Nov’11
Sr. Validation Consultant

Responsibilities:

• Involved in updating Functional Requirements document based on approved User requirements specifications.
• Involved in writing and implementation of the test plan for ePROGESA to NDDR, ePROGESA to LOGIC and CTM to ePROGESA.
• Involved in writing the test procedures using the Quality Center for various interface specification documents for ePROGESA to NDDR, ePROGESA to LOGIC and CTM to ePROGESA modules.
• Analyzing and documenting detailed program information working and interacting with software developers and members of various other dependent departments.
• Performed the Back-End integration testing to ensure data consistency on front-end (ePOGESA) by writing and executing SQL queries on the database using TOAD.
• Scheduled a job processing to trigger Surround FP file in EST and EDT.
• Developed positive and negative data for testing and created Challenge Tests, maintained Requirements Traceability Matrix.
• Executed Test Scripts for ePROGESA to CFS, eBDR to ePROGESA, CFS to ePROGESA, ePROGESA to ZipCode, Surround CR to ePROGESA, ePROGESA to Surround FP and ePROGESA to eBDR.
• Used ClearQuest for Bug reporting and tracking, followed up with the development team to verify bug fixes and update bug report status.
• Report project status, concerns and issues to QA Manager.
• Followed Agile Scrum Methodology.
• Generated XML files for eBDR database and verified donor information in front-end (ePROGESA).
• Involved in writing the Test Analysis Report (TAR) for ePROGESA to CFS, eBDR to ePROGESA, CFS to ePROGESA, ePROGESA to ZipCode, Surround CR to ePROGESA, ePROGESA to Surround FP, ePROGESA to eBDR, eBDR to ePROGESA and delivering the Interface testing Package.
• Involved in Regression testing.
• Involved in Data Migration End-to-End testing including executing the test procedure and writing the Test Analysis Report for Data Migration End-to-End System Test.
• Strong knowledge on GxP and hands on experience in 21 CFR Part 606 and 21 CFR Part 640 (Blood and Blood components, Human Blood and Blood Products).

ConfidentialIL
CAPA Project
Dec 09 – Sept 10
Validation Lead

Responsibilities:

• Analyzed Computer System Validation documents including User Requirements (URS) and
  Functional Specifications (FS) for DOORS, IAS, MiniTab.
• Remediated COTS applications (COLLEAGUE Bitmap Generator, COLLEAGUE Font Generator, QTP, Cosmic ZAP 68HC11 Simulator/Debugger, Cosmic C compiler, Paradigm c++ compiler and Dock light)
• Wrote the system test cases according to specifications and requirements and in compliance with 21 CFR Part11.
• Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology.
• Reviewed existing validated documentation and evaluated executed changes controls, reported problems, and vendor upgrades/patches in order to determine if any actions are requires such as upgrading, replacement or re-validation.
• Trained users on the system implication and provided an independent oversight about an impact of 21
  CFR Part 11 regulations.
• Daily conducted scrum meetings with analysts.
• Participated in regular project meetings and requirement/process review meetings.
• Closely worked with Subject Matter Experts (SME's) and Computer System's Owners (CSO) for gathering the requirements.
• Strong knowledge on GxP and hands on experience in 21 CFR Part 820 and 21 CFR Part 812 (Product Design, Product and Process Development).

Confidential, CA
Jul 08 – Nov 09
Validation/ QA Analyst

Responsibilities:

• Involved in updating Functional Requirements document based on approved User requirements specifications.
• Prepared Operational Qualification (OQ) test scripts for Configuration, disposition and Test Result Entry modules of APDS (Automated Plasma Dispositioning System).
• Reviewed and routed all validation documents using Quickplace for Team review.
• Worked closely with Development Team to identify the test scenarios and test cases.
• Involved in electronic loading of 3rd party supplier shipment data, ARC shipment data and BioLife Plasma Services shipment data using FTP.
• Prepared deviation logs for the various errors occurred during the testing phase of SDLC using PVCS Tracker for APDS system.
• Performed the Back-End integration testing to ensure data consistency on front-end by writing and executing SQL queries on the database.
• Reviewed Traceability Matrix in accordance with requirements and test scripts.
• Involved in executing the OQ Test Cases and PQ Test cases for Siebel CTMS (Clinical Trail Management System).
• Routed all the documents using Share point.
• Reviewed Operational Protocol and Performance Protocol Criteria.
• Performed commissioning the test scripts in Development and Validation Environments.
• Involved in Performing the Risk base Analysis for the CTMS.
• Updated and maintained the Traceability matrix.
• Involved in creating Incident Reports, routing and tracking, finalizing and closing.
• Involved in IQ final Report and OQ final Report.

Confidential, PA
May 07 – Jul 08
Sr. Validation Engineer

Responsibilities:

• Involved in the Computer System Validation in compliance with FDA regulations particularly 21 CFR Part11 and Good Manufacturing Practices (GMP).
• Involved in creation and proper execution of individual protocols, including Operational Qualification (OQ), and Process Qualification/User Acceptance Testing (PQ/UAT) for SAP ECC 6.0 roll outs.
• Documented Validation Plan, Validation Summary Report for SAP roll outs and implementing interfaces between SAP and other manufacturing systems.
• Reviewed and approved Requirement Specifications, Functional Specifications, test scripts and test results.
• Developed and reviewed Risk Analysis, GAP documents.
• Worked on preparing the business process mapping for the validation of the various Business Intelligence Reports.
• Worked on converting various validation checklists to Validation Strategy Document, URS and FRS.
• Developed SOP for Global Change Control process for SAP system changes in accordance with the company SOP’s and guidelines.
• Wrote deviation investigation report, Summary reports.
• Developed Data Migration Plan and Data Migration Summary Report for GMP data conversion process.
• Worked with security team to incorporate security testing as part of OQ test scripts.
• Involved in QA review of the PQ scripts before the start of User Acceptance Testing (UAT)

Confidential NJ
Dec 05 – May 07
Validation Consultant

Responsibilities:

• Involved in validation of SAP ECC 6.0 upgrade and SAP Support Packs implementation and Web Applications in accordance with Company policies and procedures.
• Involved in meetings with users to review and approve Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).
• Reviewed and approved Installation Qualification IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Developed Validation Plan, Traceability Matrix, Master Test Plan, Validation Summary Report documents.
• Created and Reviewed Test plans, test cases, for IQ, OQ, and PQ protocols based on requirements of the application.
• 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 Qualifying the Web applications, Client/Server applications according with 21 CFR part 11 requirements like Security, Audit Trail etc.
• Developed Validation Deliverables that are required by SDLC policy and FDA regulations.
• Conducted assessments of regulated systems to assure validation procedures have been followed in compliance with company, divisional and departmental policies and predicated rules.
• Involved in generation and implementation of QA and QC procedures and policies.
• Involved in Gap Analysis, Risk Analysis and prepared Remediation plans.
• Conducted Periodic Evaluation to demonstrate that system remains in a validated state in its life cycle.
• Developed Validation Summary Report (VSR) to summarize all validation activities.

Confidential IL
Apr 04 - Dec 05
QA Analyst

Responsibilities:

• Developed Test cases for LIMS and tested the LIMS application.
• Involved in developing user and functional requirements and translating into specifications compliant with FDA regulations.
• Validated the interface between SAP R/3 QM module and LIMS system.
• Involved in creation and proper execution of individual protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ).
• Experienced in testing Electronic Document Management System (EDMS) involving functional and user-acceptance testing.
• Involved in Customizing the Sample Manager, Project Manager according to the URS and 21 CFR Part 11.
• Conducted periodic evaluation to demonstrate that LIMS system remains in a validated state in its life cycle.
• Standard Procedures and policies are written for all aspects of the LIMS System Validation lifecycle.
• Documented Test Plans that contains test scripts, test cases, test data and expected results for the User Acceptance testing.
• Wrote deviation investigation report, Summary reports. Participate on Manufacturing Process, FDA inspection.

Confidential India
May 03 - Jan 04
QA Tester

Responsibilities:

• Involved in writing and implementation of the test plan, various test cases and test scripts.
• Analyzing and documenting detailed program information working and interacting with software developers and members of various other dependent departments.
• Checked the data flow through the front-end and back-end and extensively used SQL Queries to extract the data from database.
• Performed Functionality, GUI and Regression Testing of application using QTP.
• Used ClearQuest for Bug reporting and tracking, followed up with the development team to verify bug fixes and update bug report status.
• Followed Agile methodologies.
• Report project status, concerns and issues to QA Manager and QA Lead
• Work with the team lead to define data requirements and to identify Check points during the Interface Testing

EDUCATION

• Masters Degree in Computer Management