Summary of Qualifications:

• Six years of diverse experience in Information Technology as a Validation Engineer/Analyst with more emphasize on computer systems validation (CSV) in a Pharmaceutical and Bio-Tech Industry following GxP Guidelines - GLP, GCP, GMP, GDP
• Actively participated in Risk Assessment, GAP Analysis, and Vendor Audit before working on validation process to meet the deliverables following Good Automated Manufacturing Practice (GAMP4)
• Experienced in authoring or reviewing of different documentations of CSV lifecycle including different qualification protocols - Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Well versed with different FDA regulatory compliances including different sections of 21 CFR Part 11, Part 58, and ISO 9001
• Authored, reviewed, or approved different validation documents - Validation Master Plan (VMP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Remediation Plan, Requirement Traceability Matrix (RTM), Standard Operating Procedures (SOPs), and Validation Summary Report (VSR) following Good Documentation Practice (GDP)
• Experienced working with Trackwise(6.0) application for electronically logging, managing, and trending quality and compliance issues and action items in accordance with cGxP standards
• Verification and Validation of Documentum by creating workflows, versions, and lifecycles for documents
• Hands on experience on working and validating different modules of Laboratory Information Management System (Labware LIMS 5.0)
• Good knowledge of Software Development Life Cycle (SDLC), Enterprise Content Management (ECM) and Quality Management Systems (QMS)
• Experienced in Quality Assurance, Quality Control and Testing in both Manual and Automated Testing environments with web-based and client server applications
• People's person with an ability to work individually or in a team environment to conceptualize, drive, and deliver usable, quality project deliverables on time and to the satisfaction of customers
• Highly motivated self starter with an excellent oral and written communication skills
• Fast learner with multi tasking ability, detail oriented attitude and strong work ethics

Technical Skills:
Operating Systems: Windows95/98/2000/XP/NT/Vista, UNIX
Testing Tools: HP Quality Center 9.x/8.x, TestDirector 8.0/7.6/7.2.,
Quick Test Professional (QTP) 9. X/8.2, JIRA
Internet: ASP, HTML, XML, JavaScript, VBScript
Databases: Oracle 7/8i, SQL Server, Sybase, DB2 and MS-Access
Applications: MS Office, LIMS 5.0, DCM (Documentum), AuditCA, MS SharePoint
Life Sciences: FDA Regulations and Compliances, IQ/OQ/PQ, 21 CFR Part 11, Part 58

Professional History:
Confidential,
Fort Worth, TX JUL 2009 - PRESENT
Project Engineer

Responsibilities:

• Worked as a Project Engineer in a GLP Implementation Project to keep test facilities in compliance with FDA CFR58 at the Department of Lab Medicine and Pre-Clinical Services of UNTHSC
• Participated in the kick-off meeting along with Subject Matter Expert, Project Lead, Project Supervisor, Management, QAU, and Technicians to discuss the scope and out-of-scope of the project
• Developed SOPs on SOPs and Policies,Quality Control, Good Documentation Practice, Document Control using SharePoint, Conducting and Documenting Training, Qualification and Validation of Equipment, and Validation of Laboratory Computerized Systems
• Attended training on GLP for study personnel, and GLP Responsibilities of Management conducted by SME to determine the specific roles of QAU, Personnel, Management, and Technicians
• Trained Document Control Person on how to route the documents for reviews and approvals using Microsoft SharePoint
• As per VMP authored by the Project Lead wrote different Validation and Qualification protocols on different pieces of equipments used in GLP study
• Prepared meeting agendas and moderated weekly status meeting with everyone involved in the project

Environment:
MS Office, MS SharePoint, GLP, CFR11 and 58, DCM

Confidential,Austin, TX JAN 2009 - JUN 2009
Validation Engineer

Responsibilities:

• Actively participated in the validation of AuditCA Upgrade Project following PSC Clinical SOPs
• Performed Gap Analysis on the existing system prior to the validation kickoff to determine the various areas of improvement
• Participated in the GxP assessment meeting with the entire Validation Team and QA Team
• Reviewed the URS and participated in the preparation of Validation Plan for validation of AuditCA
• Upgraded the existing FRS and followed V-Model Validation Methodology of SDLC for the entire process
• Prepared RTM to track back the requirements, OQ scripts to FRS and PQ scripts to URS
• Executed PQ scripts manually prepared by the peers and reported error/bugs in JIRA system
• Authored OQ scripts and have them reviewed by the Project Manager and the Project Director
• Reviewed and approved Test Summary Report and Validation Summary Report
• Participated in deviation analysis and used reversed engineering to correct them or reported as a deviation in the Final Report
• Completed the project on time working with a diverse and dynamic team in consultation of different departments within the organization
• Upgraded the user manual guide based on the new changes made to the application and uploaded them on the Document Compliance Manager
• Authored training manual SOP for new versions of AuditCA and provided training to the users
• Created audit checklist for Bioanalytical Method Validation from ICH and FDA guidlelines
• Based on the checklist created reviewed Clinical Report, Validation Report, and Analytical Report on a Clinical Trial Study performed by Batterjee Pharmaceuticals Factory Jeddah-Saudi Arabia

Environment:
MS Office, Windows 2000, GMP, GCP, CFR11, AuditCA, JIRA, DCM

Confidential,Rockville, MD MAY 2008 - DEC 2008
Sr. Validation Analyst

Responsibilities:

• Managed and actively participated in the validation of Documentum Upgrade Project following FDA regulations
• Performed Gap Analysis on the existing system prior to the validation kickoff to determine the various areas of improvement
• Initiated the Remediation Plan considering the results of Gap Analysis
• Reviewed the URS and participated in the preparation of Validation Plan for validation of workflow and version control of Documentum
• Prepared RTM to track back the requirements, OQ scripts to FRS and PQ scripts to URS
• Executed OQ and PQ scripts prepared by the peers and reported error/bugs in Quality Center
• Reviewed and approved Test Summary Report and Validation Summary Report
• Completed the project on time working with a diverse and dynamic team in consultation of different departments within the organization
• Supervised validation and calibration of analytical instruments/equipments (Autoclave, Incubator, Oven, etc.) for temperature mapping studies
• Upgraded the user manual guide based on the new changes made to the Documentum
• Authored training manual SOP and provided training to the users on the upgraded version of Documentum

Environment:
MS Office, Windows 2000, GMP, CFR11-820, Documentum 5.3, HP Quality Center 9.2

Confidential,Owing Mills, MD NOV 2006 - APR 2008
Validation Analyst

Responsibilities:

• Responsible for development, execution (manual) and reviewed functional and UAT Scripts for Sparta TrackWise 6.0 Implementation
• Worked closely with a diverse team being able to work amicably both as a peer and as a mentor
• Participated in risk assessment meeting and helped draft a Validation Plan
• Involved in the preparation of the Gap Analysis and also developed Remediation Plan based on GAP Analysis
• Participated in writing OQ scripts for TrackWise Admin Module Version 6.0 (tested functions like Team Access, User Authentication log screen, User roles, Admin Audit Trail etc.)
• Reviewed the SOPs (Standard Operating Procedures) outlining the validation activities, SDLC process, following the Technical Writing Procedures
• Reviewed the User Requirements Specifications (URS) and wrote Functional Requirements Specifications (FRS)
• Prepared Test Plans, following the Technical Writing Procedures and URS
• Performed User Acceptance Testing (UAT), to make sure the system works as per User Requirements
• Prepared Requirement Traceability Matrix (RTM) traceable to User Requirements and Functional Requirements
• Reported Trackwise deviations and mentioned it on the Validation Summary Report

Environment:
MS Office, Windows 2000, GMP, CFR11, Trackwise 6.0

Confidential,Fort Worth, TX JUL 2005 - OCT 2006
Validation Analyst

Responsibilities:

• Prepared Validation Plan to upgrade Laboratory Information Management Systems (LIMS) from version 4.0 to 5.0
• Responsible for documentation of all phases of System Development Life Cycle (SDLC) as required by FDA regulations under 21CFR Part 11 (Electronic Records and Electronic Signatures)
• Followed FDA regulations under 21CFR Part 11 (Electronic Records and Electronic Signatures) to write security SOPs for control of authenticated user access
• Participated in security control (electronic signatures, proper approval with justifications, ensuring proper validity and quality check for the customized version of LIMS)
• Created Test scripts for Labware LIMS system to test LIMS functionalities based on System Requirement Specification document
• Interacted with Subject Matter Experts (SME's) in the Production Department and R & D Department to enhance the effectiveness of the test scripts
• Created Traceability Matrix document for the created Test scripts mapping to the System Requirement Specification document
• Performed Adhoc testing for LIMS, as the new developments were deployed in testing environment
• Performed configuration testing of the LIMS on different versions of windows to ensure compatibility

Environment:
LIMS 5.0, MS Office, CFR Part11, TestDirector

Confidential,Cranbury, NJ AUG 2004 - MAY 2005
Validation/QA Consultant

Responsibilities:

• Performed validation activities for Documentum Enterprise Content Management (ECM) for the Research & Development (R & D) group
• Responsible for ensuring that all documentation and procedures comply with the FDA 21 CFR Part 11 and cGxP guidelines
• Performed Gap Analysis by identifying the area of contention where the application under observation did not meet the standard Requirements
• Followed Validation Master Plan and authored Test Plan for entire validation process
• Revised user requirements and developed functional requirement specification document based on user requirements
• Responsible for creatingtest scripts, test cases, reviewing and verifyingtest results by following Technical Writing Procedures, identifyingand reportingissuesandproviding test summary reports
• Performed Functionality testing and User Acceptance testing, Positive testing and negative testing until all the QA checkpoints were cleared
• Responsible for updating weekly status of automated testing using QTP 8.2
• Documented all phases of system life cycle as required by FDA regulations under 21CFR Part 11 (Electronic Records and Electronic Signatures) and successfully completed QA checkpoints
  

Environment:
MS Office, Oracle 8i, SQL, Windows 2000, ECM, FDA Compliances, QTP (8.2)

Confidential,Austin, TX JAN 2004 - JUL 2004 Validation Engineering Intern

Responsibilities:

• Shadowed Validation Lead Engineer in projects related to Computer System Validation and Equipment Validation
• Wrote and executed Validation protocols such as OQ and PQs
• Generated Excel Spreadsheet and drafted Summary Report for PQ studies
• Calibrated thermocouples for temperature mapping studies
• Participated in Equipment Validation Studies and generated test procedures to validate new or previously validated equipment or processes
• Participated in reviewing and modifying of Standard Operating Procedures(SOPs) for different equipments and systems
• Developed extraordinary skills on technical documentation of different validation protocols following different regulatory compliances

Environment:
MS Office, GAMP, Clean Room, FDA Compliances

Education:
Master of Science
Major - Biomedical Engineering