Quality Assurance Software

Guerra Parafino

**** ***** ****** **.

Round Lake, IL 60073

815-***-**** ********@*****.***

Summary:

. Over 13 years in IT QA Leadership, in varied experience field of IT

with importance on Software QA in FDA and EMEA Regulated environments,

testing of software applications including over 6 years for Abbott

Laboratories in HPD, PPD, ADD and Sales and Marketing divisions

supporting worldwide customers and over 5 years for PharMEDium

Services.

. Functioned in the role of Lead Support for Verification and validation

efforts and deliverables.

. Executed functional, automated, manual, system test procedures.

Documented software test results and ensuring software is error free.

. Updated test cases, test plans, test scripting based on user Needs,

specification and Systems Needs documents, test results, updating

validation and verification test procedures.

. Used custom tailored test methods in accordance with validation policy

SOP standards.

. Verified software performance and Knowledge of 21 CFR Part 11

compliance for eData.

. Setup for validation protocols execution, schedule and update forecast

in compliance with SOP.

. Executed Low Level Design (LLD) and High Level Design of validation

test cases.

. Wrote Validation Plan and Test Plan, Process and test cases.

Documentation for system level tests.

. Performed Manual and Automated testing including regression testing,

integration test, pilot testing, performance testing, user acceptance

test, Unit Testing, security testing and Single Thread using: Writing

of Documentum 4ix, 5ix protocols test cases.

. Executed Wireless Barcode Scanners validation and verification to

insure radio frequency identification (RFID) where met in all

facilities, and Zebra PDA Label printers in compliance with FDA

. Filed validation documentation within Quality Assurance Library

guidelines SOP.

. Created and validated and launched into production MS Access Database

for use of Surveying Library Patron's lifestyle interests currently in

use.

. Performed back-end SQL querying scenarios using test scripts, and

front-end record verification on Siebel GUI.

. Experienced in the installation and synchronization of PDA's with

Laptops and CRM Servers on PDA calibrations.

. Worked with embedded/real-time software C, C++. Participated in

evaluating software requirements, software source code and

specifications.

Education:

BA in Business Accounting, Eduardo Mondlane University, Portugal

Associates degree in Photo Journalism, Coimbra University, Portugal

CIS Certification, North Dakota State School of Science, North Dakota, USA

Languages:

English, Spanish and Portuguese

Awards/Recognitions:

. Member of Toastmasters at Abbott Laboratories 2002 - 2004.

. Recipient of a Plaque, for Jupiter iTeam from Abbott Laboratories in

recognition of engineer of the Month - 2001.

. Recipient of a letter of highest recommendation from Abbott

Laboratories for employment in any firm seeking a dedicated, high

caliber professional - 2000.

. Recipient of Plaque for a Manufacturing & Research Systems in

Innovation, Technology, and Value in recognition of the success for

Abbott Laboratories, Hospital Products Division (HPD) -1999.

Technical Skills:

Emulators: Chameleon, Rumba Xclient/Manager, Reflection for ReGis

Graphics, Scribe, Citrix

Hardware: WAN, Through T-I Lines, TCP/IP/IPX, Alpha/Server, DEC/VAX,

Client/Servers Routers, DEC 9000, Dynamic Switch

Hubs, Dedicated Remote, RAS, Hub Watch, Tivoli LAN

Management System, Frame-Relay, Laptop, Desktop,

and PDA

Intranet: MS-Outlook, Lotus Notes, Web Publisher, Total Internet,

Firewall

Environments: FDA/EMEA, CFR 21 Part II, for cGxP, cGMP, cGCP, cGLP,

compliance, ISO a Safety Performance Specifications

and Methods of Test

Operating Systems: Win95/98/00/03/XP/Win7-WinNT, DEC VAX, AXP,

Alpha/OpenVMS, AS/400, UNIX and Vista and Citrix.

Software (Desktop / WebTop): Oracle, Documentum 4ix, 5ix, suites, Exstream,

Cobol, Visual Basic, HTML, XML, CRM customization on Siebel Life Sciences

7, SQL Server 2005, MS Office, MS-Publisher Deluxe with Photo Editing,

Semantic ACT, Basis, SCR-Tracking, LCRN-Tracking, AutoCad, Ingress,

CoreDossier, Java Microsoft Dynamics..

Experience:

Abbott Labs 03/2012 - 08/2012

QA Analyst on iQ - Innovative Quality for ENOVIA Life Science Accelerator

. Responsible for Authoring Protocols, Reviewing Protocols, Updating

Protocols, analyzing Protocols, UI-User Interface verification, IU-

Design Review, Executing Protocols, and Peer-review.

. Business Process for the following core of ENOVIA upgrade and

Enhancements.

. iQ Core - Validation System Test Traceability Matrix, AN Complaints

Module Product Evaluation testing, Abbott AAH-Animal Health Complaints

Module testing, Abbott Nutrition (AN) testing, Devices Complaint

testing, Inventory testing, ADD Integration testing, Abbott

Diagnostics (ADD) - Customer Complaints Module testing, Validating -

iQ Core - ADD Returns and Product Evaluation (CMS), ADD Medical

Evaluation and Submissions testing, Electronic Medical Reports for

MDR, MDI, MedWatch 3500 and CIMOS eSubmissions, Platform Audit Quality

and Regulatory testing, Unit Testing, Label Job Packet testing, Stage

Gate Module testing.

. Responsible for Defect Tracking, Incident Reporting, and 21 CFR Part

11 in FDA/EMEA compliance.

. Ensured the quality assurance in a SDLC is met.

. Attending meetings with Application Software vendors along with

developments team and clients across divisional work flow to meet

business need. Meet up Member of Chicago chapter.

Environment: Citrix, Cognos, HP QC, Web based Application

PharMEDium Services, LLC, Lake Forest, IL 2006 - 2011

QA Lead Validation Analyst/Tester

. Responsible to build QA team from ground up. Developed IT/SOP QA/SOP

monitored testing team mates and guided in defects tracking of

software application and strong team player.

. Planned and scheduled for the development of the projects, ensuring

the QA requirements projects of SDLC are met.

. Reviewed the batch records and necessary data, test cases and user

requirement interface are running the application effectively.

. Attended meetings with vendors suppliers, developers as well as

clients, updated IT management with the necessary details of projects

forecast status. Accountable for budgeting and scheduling in projects

implementation.

. Risk analysis across various departments in analytic work flow of

projects, strengths in communications to achieve strategic business

goals.

. Responsible for new off-the-box customization or enhancement, as well

as CAPA initiative projects.

. Managed in planning strategies for product development full-blown

testing team to ensure their working adherence to plans and SOP

methods compliance.

. Audited and inspected projects milestone prior to deployment unto

production, ensured safety measures in project operation are

accomplished prepared documents and records deployment certification.

. Wrote and understood SOP Change Request control, assisted in

installation and configuration.

. Interpreting of SDLC Life Cycle Methodology and understanding of

Decommissioning Phase process including Validation Certification

Process.

. CFR 21 Part 11 for Electronic Records and Electronic Signature

Inventory Evaluation, Remediation if applicable.

. Writing of Test Plan, test process and Traceability Matrix. Writing of

Validation Protocols for pharmedium.com web-based application of test

cases and setting up testing in Client server environment including

Agile testing methodology, Regression testing, Unit testing,

Functional testing, Audit testing, System testing and Integration

testing.

. Writing of validation protocols for Controlled Substance Ordering

System (CSOS), Labeling Inventory and Narcotics Tracking Software

(LINT), PharNet Web Application test cases in the Web based apps, Plus

Software Labeling and wireless barcode scanners application,

PharMEDium Label User System Software (PLUS) and Web ePLUS.

. Understating of Design Qualification (DQ), executed Installation

Qualification (IQ) hardware and software checks to ensure it meets the

necessary requirements. Operational Qualification (OQ) Prior to

execution of the OQ all critical Instrumentation (calibrated

instruments) and Performance Qualification complete with inspection

(PQ), including customized detailing baseline systems usage.

. Executed Wireless Barcode Scanners validation and verification to

insure radio frequency identification (RFID) where met in all

facilities, and Zebra PDA Label printers in compliance with FDA.

. Writing of validation protocols for Batch Verification System (BVS)

designed to provide a method of verifying all batch components and a

PDA wireless scanner and the barcode Client Server, Web base testing

application.

. Writing of Protocols for Symbol barcode in the FoxPro environment.

. Setup for validation protocols execution, schedule and update forecast

in compliance with SOP.

. Developed validation Incident reporting template and Protocol

Execution, Data Collection and Peer Review.

Environment: Citrix MetaFrame, FoxPro, and Web Client, Applet web base

applications

Abbott Laboratories, Abbott Park, IL 07/2005 - 12/31/2005

QA Validation Specialist

. Lead/support validation efforts and deliverables for Product Complaint

Analysis (PCA) in Cognos environment Data Warehouse a Web based

Application.

. Identified Medical Complaints (PCA) and Non-Medical Complaints (PCA)

for Active Pharmaceutical Ingredient Complaint Detail (API); CFR 21

Part 11 compliance lifecycle software application.

. Create and execute UAT validation test scripts and document test

results in accordance with standards.

. Review and evaluate validation assessments for application

systems/projects.

. Writing Standard Operating Procedures and validation policies.

Review/revise Validation Policy and SOP's as directed

. File validation documentation within following Quality Assurance

Library guidelines in FDA/EMEA compliance.

. Customer Service Focused, System Audit /Validation in compliance with

Quality/Regulated environment

. Knowledgeable and understanding of IT concepts and word processing and

spreadsheet skills.

. Assisted in implementing and installation and configuration.

. Setup for validation protocols execution, schedule and update forecast

in compliance with SOP.

Environment: Citrix, Cognos, HP QC, Web based Application

TNT - The Northern & Trust Bank, Chicago, IL 12/2004 - 06/2005

VAX-OpenVMS QA/Tester Analyst

. Worked in the CIT Support Group at TNT - Responsible for SDLC software

development, writing test scripts on, .COM files, coding in DCL C++

using DECforms, and RDB on the VAX/OpenVMS platform.

. Conducted coding in .COM to assign, defined and purged/log files for

automatic triggering of all job batches to update client transactions.

. Responsible for revising, reviewing, updating and executing UAT of old

and new test scripts of .COM files in a VAX/OpenVMS Dev-Server

environment, using DCL coding and VSQL-VAX SQL in WinXP environment.

. Conducted data and impact analysis, queries back-end datasets, table

using VSQL, utilizes Lockbox services for data extraction and FTP for

network file transfers and uses Business Management System (BMS) to

extract .TXT from IBM and Xnet web-based application into VAX.DAT

files.

. Verified and analyzed .LOG files for any deviations of .COM files are

deployed into the production server environment.

. Submitted batch jobs to process the following: trading, pricing,

cashmove, settlements, fees, rejects reports and other pre-approved

and post-approved banking transactions.

. Followed up with client's inquiries, provided on-call support and set-

up of DIS: Intranet mail services over Lotus Notes Domino for

FIRECALLING CIT support group when any system problems occurred.

. Setup for validation protocols execution, schedule and update forecast

in compliance with SOP.

Environnent: VAX 8500, IBM Mainframe Platform, Web sph re, Solaris

Abbott Laboratories, Abbott Park, IL 1998 - 2004

QA/Lead Validation Analyst

. Worked in the CORP, GTS, CRQS and PPD divisions while in this role.

Worked with Core, CRM customization Siebel Life Sciences, CFR 21 Part

11 compliance lifecycle and FDA/EMEA compliance.

. Conducted validation and testing for Abbott Laboratories Sales and

Marketing divisions, supporting their worldwide customers and their

marketing reporting analysis activities, which were dependent on

several different systems including: Via, Nucleus ePharma, Regression

Testing, UAT Testing, Unit Testing, Integration Testing.

. Executed bulk load flat files data EIM interface tables using SQL

Loader and TOAD querying.

. Modified the EIM Table Mapping SQL loader CTL files and input Tables

for populating data into the Siebel database.

. Performed back-end SQL querying scenarios using test scripts and front-

end record verification using Siebel GUI.

. Wrote and executed UAT's test scripts for both Low Level Design (LLD)

and High Level design (HLD), which including revising, updating,

reviewing and gap analysis on incident reporting.

. Setup and managed validation protocol testing environment. Involved in

major configurations of modules such as Siebel: activities,

professional management accounts, objective accounts, calendar

accounts, smart call, professional call, account call, inventory and

product sampling.

. Conducted major PDA (HP handheld) calibration for the professional

sales force and also for remote users.

. Involved in the infrastructure setup for test, development and

production environments for archiving historical.

. Executed new Multi-Value Group (MVG) applet links, and pick lists to

meet business requirements.

. Functioned in the role of Lead Support for validation efforts and

deliverables. Validation plans, functional requirements specifications

(FRS).

. Documented test results in accordance with validation policy SOP

standards and Quality Assurance Library guidelines for the following

software: Documentum 4ix, 5ix, MedWatch, CRLN-Tracking, Bar-Code,

iCAS, CAPA, FileSurf, RAITS, ATLAS and Kintana in XML files using web

content generation WebLogic, in WebTop applets eBrowser and

systems/eData.

. Conducted hands-on implementation and design of test-plans, test

procedures, workflow, writing and creating Test cases using

departmental templates in accordance with SOP guidelines, and

executing Test Scripts and Test Cases for projects.

. Traceability Matrix will list project and related technologies,

Summary Reports, Incident Reporting and recommended action be taken

when there when any deviation encountered for cGxP, cGMP, cGCP, cGLP,

IQ, OQ, PQ, scorecards. ISO a Safety Performance Specifications and

Methods of Test.

. Experience in Validation Change Requests (VCR), Validation Software

Problem Reports (VSPR), Validation Incident Reporting (VIR).

. Setup for validation protocols execution, schedule and update forecast

in compliance with SOP.

Environment: VAX 4700, Alpha server, MS server 2000, MS server 2003, UNIX,

Siebel BEA-Weblogic server, Auto Render-Pro, Solaris, Mainframe and Web-

Publisher.

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