VAlidation Analyst

Objective: Applying to obtain this challenging position, and to utilize my experience and educational background in software validation and development, for a better Software Quality.

Technical Skills:

Applications/Languages: Visual Basic 5.0 / 6.0

Operating systems: DOS/MS, Windows 95/98/NT/2000/XP Professional SP2/2003.

Software and Tools: SQL Server 6.5, Crystal Reports 6.0, Access 97, LOTUS NOTES, EXCEL, MS/SQL, Power Point, Acrobat, MS Visual Source Safe, Metaphase/Metaweb, Auto CAD, Calibration Manager 3.0. Gage Track 6.0, BPCS, MINX, Contract Assistant 5.2, Online Wholesale Lockbox (OWL), Transaction Management System (TMS) and Citrix Metaframe, Xybion Pathology, Toxicology and Clinical Pathology System, Siebel 8.1.1, Documentum 6.0, Package Wizard, SAP, SPP Repository 2.2 and TrackWise 6.0.

Automated Testing Tools: Mercury’s Win Runner 6.0, Test Director and Quick Test Pro (QTP).

Web Related: HTML, JavaScript, and VB Script.

Professional Experience:

Validation Lead TEK systems Inc/Delta-Pharma Inc. 10/15/2007-06/30/2011

(For the Takeda Pharmaceuticals North America, Inc., ITQS, Deerfield/Bannockburn, IL)

Serving as Validation Leader, managing “off-shore” testing team of 5 people.

Providing expertise, training, and support to business clients and developers, to assist them bringing regulated and non-regulated systems in compliance with existing industry’s regulations.

Validating system that provide functionality within the Quality Assurance (QA), Call Center (CC), Pharmacovigilance (PV) and Medical Information (MI) departments, to capture and respond to Product Information Requests (PIR) and Product Complaints (PC).

Validating, evaluating and qualifying process management tools and document management systems.

As a member of decision making group, involved in assessing computerized systems for regulatory applicability and regulatory compliance.

Developing Remediation plans based on system’s Gap analysis.

Serving as a Business Analyst analyzing User’s requirements and translating them into Functional requirements

Working together with Application Development team, transforming the functional requirements into Design Specifications

Developing and executing project validation deliverables, such as; Validation Plans, Migrations Plans, IQ/OQ/CQ, System, Integration and UAT test scripts.

Designing Development Summary reports, Trace matrices, System Maintenance Manuals, Disaster and Back-up and Recovery plans, Validation Reports and other documentation deliverables required by the internal SDLC and Change Control polices.

Reviewing, recommending, and implementing process improvement techniques to increase test quality and improve test productivity.

Validation Analyst Manpower Inc. 05/12/2006-09/07/2007

(For the Abbott Laboratories, Global Pharmaceutical R&D IT, Abbott Park, IL)

Performing validation of the scientific GLP system from functional and performance perspectives.

Developing and executing Validation Protocols necessary to confirm user requirements and functional requirements to insure software quality.

Providing guidance, support and review of the project deliverables.

Participating as a technical team member in design and testing of the system architecture, also participating in writing of the System Architecture Description document.

Participating in writing of the software “Back-up and Recovery” plan and assisting in it’s testing.

Writing Installation Qualification and Operation Qualification for a various devises, (balances, Biometric

Chip readers, barcode readers, label printers, etc.), and applicable software.

Executing Installation Qualifications for the instruments (analyzers) utilized in conjunction with a system, to process and analyze the data collected during the scientific experiments and clinical studies.

Developing Devises data verification methods & standard operation procedures, participating in systems testing, preparing program test data (study setup).

Working as a liaison between clients, and developers, coordinating efforts to mitigate and solve software issues, and developing solutions to business and technical problems, (Customization of Reports).

Effectively communicate to a middle management to inform them of associated quality and compliance risks identified with each software issue to obtain support and resolution/mitigation of risk.

Managing tasks with respect to milestones, and in accordance with existing standards, methodologies, and processeses.

Assessing software processes and procedures to determine computerized system’s capabilities to meet internal requirements and FDA regulation.

Conducting “root-cause” analysis for software usability problems (Gap Analysis), and providing recommendations for the improvements (Mitigation plan).

Providing interpretation, guidance, and training for clients in regards to computer system validation and related FDA/worldwide regulations/guidelines and corporate and GPRD policies/procedures.

Developing various quality matrixes to monitor and improve performance of the validation process.

Managing multiple and changing priorities.

Working directly with an outside vendors and consultants, performing “on site” vendor’s audit and analysis of their products and operations.

Validation Analyst J & B Software 03/27/2006-05/11/2006

(For the JP Morgan & Chase, Chicago, IL)

Participating in testing of Web-based applications RemitOne Administrator and RemitOne Migration

Databases (bank-to-client, bank-to-bank transactions).

Communicating with profile team on gathering requirements for customization of customer’s profile.

Performing set-up and maintenance activities for the test environment (preparing a test data and templates) utilizing Online Wholesale Lockbox (OWL), Transaction Management System (TMS) and Citrix

Metaframe.

Participating in development of test plans and test scripts for Collect groups as well as Lockboxes validation activities.

Participating in creation of test matrices.

Reviewing and evaluating validation assessment for the Lockbox migration activities.

Developing and performing system acceptance test scripts for aforementioned system modules.

Business Systems Analyst Technisource Inc. Milwaukee, WI 07/11/05 – 03/24/2006

(For the Hospira, Inc, Lake Forest, IL)

Participating in development of a project deliverables (required documentation) for the “Off-the-shelf” software packages planned to be implemented.

Developing strategies, and provide guidance throughout the scope of implementation projects.

Conducting “in-depth” analysis of the requirements and specifications provided by the business clients, following with strategic project planning for the entire validation phase of the project.

Working closely with business clients to identify areas, which fall into a Sarbanes-Oxley act requirement (SOX) to mitigate the impact on the existing software applications and bring it in compliance with aforementioned regulations.

Reviewing and evaluating validation assessments for application system/projects

Participating in test cases development and execution.

Facilitating and coordinating the group of experts, which was developed and tested software applications, servers and databases.

Monitoring the systems production support queues as well as coordinating timely resolutions between the IT Team and the Business Users.

Reviewing and revising validation policies and SOP’s.

Software Quality Representative Espo Engineering, Willowbrook, IL 05/15/04 – 07/09/05

(For Dentsply Professional, Des Plaines, IL.)

Providing technical leadership for multiple software validation projects:

Developing and validating MS Excel Repetitive-Use Spreadsheets including those with advance programming (Visual Basic Application Macros).

Developing and validating MS Access Databases including those used in the production environment interacting with other software applications and programs.

Participating in validation and verification of “Off-the-shelf” software packages.

Conducting Software Inventory, (identifying company’s software packages and developing a tracking system).

Identifying software gaps (non-complied functionality) in respect to the FDA CFR Part 11 with further risk analysis and mitigation activities planing.

Developing Company’s Remediation and Master Compliance plans for a New and Legacy systems.

Creating Validation Plans, User Requirements, and Functional Specifications as well as tests and test scenarios for the validation/verification activities.

Adapting corporate software development and validation policies for divisional needs.

Participating in development and implementation of the Web-based Software/Hardware/Network Change Control (CR) System.

Improving company’s quality system.

Developing SOP’s, User Guides and Work Instructions for the software packages, processes and methods utilized by the company.

Conducting training for the employees.

Facilitating consultations, updates and overviews on the latest FDA polices and guidelines.

QA Tester /Analyst Systegration, Inc., Glenview, IL 05/20/03 – 05/13/04

(For Avanade, Inc. (joint venture of Accenture Inc. and Microsoft), Chicago, IL)

Participating in testing of Web-based applications for banking systems.

Communicating with development team to gather requirements for creation of test documentation.

Performing set-up and maintenance of test environment (test data, templates, and Defect -Tracking and reporting system).

Participating in development of test plans and test scripts for a Loan Origination System.

Participating in creation of test matrixes for Master Commitment (bank to bank agreement for loans).

Reviewing and evaluating validation assessments for system applications.

Developing and performing system acceptance test scripts of various system modules.

SQA Engineer Baxter Healthcare Corp. 05/2002 – 03/2003

Providing technical leadership to the Core Deployment team for the implementation of robust processes utilizing such methods as, risk (hazard) analyses, mitigation plans, and formulation and support of validation/quality plans.

Developing “In-depth” knowledge in understanding of 21 CFR Part 820, and Part 11 FDA Quality System Regulation for medical devices.

Developing strong understanding, and ability to interpret quality policy GMP/GLP/GDP.

Creating validation protocols (IQ, OQ, and PQ) for “Off-the-shelf” and “In- house made” software.

Assisting in Decommissioning for the obsolete computerized system.

Participating in product development by representing Quality Assurance team in design activities.

Providing guidance and support in the development of the quality system.

Developing and conducted the Data Migration between obsolete and new systems.

Developing strong understanding of the product, including terminology associated with the product use and failure modes, typically experienced by the customers.

Designing Standard Operating Procedures and Work Instructions.

Conducting capability studies.

Creating test plans.

Providing guidance and support for the product and process issues.

Validation Process Analyst Allstate Insurance Co 12/00- 5/01

Designing test plans for integration and system testing.

Meeting weekly with business partners and clients to hammer down test conditions, address business requirements propositions, and pass resolutions to the development team.

Performing code analysis, correction and overall enhancements.

Reviewing standards and confirmed product compliance.

Utilizing AS400, DB2 and SQL server databases to conduct White-Box and Truth Testing for validations purposes.

Providing business data, rules and “logic” for the testing team.

Creating “Line-Placement” scenario conditions, (step by step walk through the Web site, using specific business requirements)

Testing Web based application with different user profiles to simulate real-time usage for the on-line application.

Producing tracking logs such as Excel spreadsheets and Word documents.

Developing, modifying, and executing test cases utilizing Automatic Testing tools such as, Test Director, WinRunner, and Microsoft Visual Source Safe

Reporting bugs and issues to management.

Interacting with application designers, data architects and management, establishing guidelines, resolving outstanding issues, and insuring smooth production release.

QA Engineer/Analyst Abbott Laboratories 2000-2001

Participating in setting up business requirements for transferring system from client-server environment to the web.

Utilizing FDA standards while validating “in-house” made software.

Assisting programmers executing unit tests.

Creating test data and mined other data for various test scenarios.

Executing test cases and documenting results.

Monitoring reported feed back to development on variations.

Creating and supported Test Director Databases.

Reporting inconsistencies and advised management of where we are with respect to deadlines, other concerns.

QA engineer/Analyst V.I. Industries 1998 –2000

Participating in IT group internal team meetings in order to provide input.

Performed code analysis, correction, and helped with the unit testing efforts.

Designing test plans for system testing.

Designing test case templates and suggested designs for document templates.

Working with other team members to design test cycles and test-case execution procedures.

Generating problem reports during all phases of the life cycle.

Creating and maintained defects system-using MS-Access.

Ranning various testing procedures utilizing WinRunner 5.0.

Meeting regularly with QA Coordinator and Facilitators to discuss direction of SQA and current issues.

Assisting with training for new QA Analysts.

Programmer: AKTA Inc., 1996 –1998

Participating in most of development walkthroughs, reviews and inspections.

Supporting programs written on the Visual Basic, and designed database to dynamically build HTML forms based on database contents.

Supporting users with consultation and technical assistance.

Occasionally traveled to the clients’ site to troubleshoot issues and work on fixes.

Maintaining databases utilized by the company.

Strengths:

In-depth knowledge of development, testing, and supporting environment.

Excellent coordination and analytical skills.

Ability to work with minimal guidance.

Knows when to elevate issues to higher management.

Self-directed to achieve project objectives.

Extensive skills in teamwork, problem solving, decision-making, organization and time-management.

In-depth knowledge in understanding of 21 CFR Part 820, 211 and Part 11, FDA Quality Systems and Regulation for a software and medical devices.

Deep understanding and ability to interpret quality policy GMP/GLP/GDP.

Extensive knowledge of the Software Quality Assurance methods and techniques.

Enjoying working independently and love the team spirit.

Seminars/Training:

• FDA Audition of Computerized Systems for 21 CFR Part 11 Compliances.

• FDA Electronic Record keeping and Signatures.

• Software Verification and Validation Strategies.

• Medication delivery Good Documentation Practices.

• Medication Delivery, Quality System Regulations.

• Computer System Validation Methodologies.

• SDLC and Change Control

Education: 1990 – 1996 KIEV Institute of Technology Kiev, Ukraine, Bachelors Degree CIS.

Availability: Standard (two weeks).

References/Recommendation Letters: Furnished upon a request.

Contact this candidate