OBJECTIVE:

Validation engineer with 8+ years of experience in implementing validation techniques according to compliance protocols, quality assurance and business analysis. Seeking to offer expertise in life science applications and other computer systems in FDA, GAMP regulated environments through exceptional communication, developmental and motivational skills and coordinating with internal and external clients.

PROFESSIONAL SUMMARY:

• Over 8+ years of experience as a Validation Analyst with extensive knowledge of GxP regulations
• Strong working knowledge on computer system validation
• Strong understanding of the Software Development Life Cycle and the deliverables for the GxP compliant systems
• Worked closely with the vendor and other third - party companies in developing and reviewing the User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) of various systems
• Professional experience in validation practices with a good understanding and practice of GxP (GLP, GMP, GAMP 4.0, GAMP 5.0) standards
• Professional experience in 21 CFR Part 11, 210, 211, 820, ISO 10993-1, 14971,13485
• Comprehensive knowledge on validation strategy and validation guidelines
• Experienced in authoring validation deliverables and in development of validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for the related applications and Standard Operating Procedures (SOP), User Acceptance Testing (UAT)
• Authored reports such as Risk Assessment, Validation Master Plan, Validation Protocol, Test Protocol and strategies, test summary report, validation summary report and maintained requirement traceability matrix
• Hands on experience in Corrective action Preventing Action (CAPA)
• Excellent team player, good communication skills, ability to learn in a fast-paced environment

TECHNICAL SKILLS:

CSV Skills: FDA guidelines, GAMP regulation, 21 CFR part 11, Part 820, ISO, Data Integrity, GDP, cGxP regulations

Technology and Validation Tools: HP ALM, V-model, CAPA, SDLC, Agile methodologies

MS Office: MS word, MS Excel, MS PowerPoint, MS Project, MS Visio

Databases: SQL

Programming Languages: SQL, HTML, CSS, R

Business Analysis Tools: Tableau, Power BI, Snagit, JIRA

GxP Application: Veeva Vault QualityDocs, E-Learning - SAP Successfactors, Labvantage 7, Trackwise

Data Migration and ETL Tools: M Microsoft SSIS

Miscellaneous tools: Adobe Photoshop CC, Articulate Storyline 2, Mail Chimp, Blackboard

WORK EXPERIENCE:

Confidential

Senior Validation Consultant / Business Analyst

Responsibilities:

• Participate in HLRA with the team members to determine a suitable validation plan
• Review the provided validation toolkit, Developed Validation Plans, Validation Summary Reports, Gap analysis with Business Teams, SME’s, project managers and IT department members
• Suggest suitable recommendations for to managers and project leaders
• Participate in reviewing URS, FRS, FRA, DS, deviation plans with the validation team and SMEs
• Assist with the vendor selection and assessments to pick a suitable product to replace the existing system after reviewing vendor documentation
• Prepare business workflows with the business analysts for the new change requirements due to the upgrade
• Participate in preparing User Acceptance Testing, IQ, OQ and PQ, performed test scripts, test cases, SOPs, recorded, reviewed and verified the results.
• Manage meetings to review FDA validation protocols and procedures regarding 21 CFR Part 11 Guidance for Industry.
• Prepare change control procedure for the system that matches the user requirements and functional requirements with the upgraded version
• Perform change impact assessment after upgrading with the team members and submit for approval
• Assist with the data backup and migration procedures before the upgrade with the project manager and the system engineers
• Write working instructions and new documentation for the new features in the upgraded version for all types of users such as administrators, trainers and trainees
• Work in coordination with the Business Analysts, IT members, validation team members and group managers to discuss and eliminate the various issues encountered

Environment: - SAP Successfactors, HP ALM, Windows 8.1, Microsoft Office, JIRA

Confidential, Waukegan, IL

Validation Analyst

Responsibilities:

• Review user requirements and functional requirements with the business analysts, vendor specialists and project managers during the system selection process
• Perform risk assessment to ensure the compliance with the FDA rules and regulations
• Assisted the business analysis team with developing business workflow diagrams to understand the business functionality
• Make recommendations to the project managers and team leaders
• Review vendor specifications and package to compare with the user requirements
• Prepare the validation master plan to evaluate the system
• Assisted the developing team to plan configuration of the system before implementation
• Assisted in customizing the dashboards that matches the requirements
• Create test scenarios that matches the user requirements
• Create validation plan, procedures, test cases, test accounts, test data and test case summary
• Prepare the IQ/OQ test cases and document the deviations
• Perform CAPA to mitigate any risks and deviations detected
• Perform UAT tests on the system to ensure that all the specification of the URS has been tested
• Prepare the validation summary report, close all deviations and perform post execution sign off
• Reviewed Data Migration plan and prepared a Data Migration Summary document.
• Assisted in writing SOPs to match the system
• Prepare training guides and user manuals for the users

Environment: Veeva Vault QualityDocs, HP ALM, Windows 8.1, Microsoft Office, JIRA

Confidential, San Francisco, CA

Validation Analyst

Responsibilities:

• Reviewed Validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations in the Software Development Life Cycle
• Review change control documents, perform impact assessment and submit for approval
• Participate in High Level Risk Assessment (HLRA) to determine the suitable validation plan for the system
• Interacted with the Research & Development team in gathering and documenting User Requirements Specifications (URS)
• Drafted and reviewed Functional Requirements Specifications (FRS) for LIMS sample module.
• Created Test Plans and uploaded in Quality Center, executed and validated Test cases, validated the Test Reports generated by the LIMS application for compliance with 21 CFR part 11 requirements.
• Authored documentation for all aspects of the computer systems validation lifecycle in accordance with FDA regulations, particularly 21 CFR part 11, including Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ)
• Updated Design Specification (DS) document and validated audit trails for events time stamping requirements.
• Created and maintained Requirements Traceability Matrix (RTM) to track user and functional requirements.
• Configured dashboards according to user requirements
• Drafted Working Instructions for different users of the application and assisted in drafting the Standard Operating Procedures (SOP).
• Drafted Validation Summary report (VSR) and assisted the team to complete the project successfully.

Environment: - Labvantage 7, Windows 7, HP ALM, Microsoft Office

Confidential

Validation Analyst / QA Tester

Responsibilities:

• Assisted in requirements gathering, business analysis and requirement analysis following the SDLC
• Assist in developing the business workflow and build diagrams
• Conducting ad-hoc testing activities in order to verify behavior and compatibility of Acer with related to new releases
• Assisting in installing Viztac Acer in the multimedia lab and guaranteeing the system availability according to the decided service standards
• Installing and configuring Microsoft Windows 2008 R2, Microsoft Windows 2012 Server Operating Systems and installing Microsoft SQL Server 2008 RDBMS to servers
• Installing, configuring and troubleshooting all client workstations and maintain Operating Systems
• Ensure security is established according to the Sri Lanka Computer Emergency Readiness Team (SL CERT)
• Created and authored documentation for all aspects of the computer systems validation lifecycle including the Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) and Validation Summary report (VSR) according to the National Health Policy Standards
• Implementing preventive maintenance measure for the physical servers and workstations by performing diagnostic checks according to the SOP
• Contacting Original Equipment manufacturers, generate reports based on the information received to recommend hardware and software upgrades to support the system infrastructure
• Perform manual testing on the integrated components in the system
• Monitor performance of the system, report on the least performing modules
• Research and suggest improvements for the user interfaces
• Report noted defects of the system to the developers and suggest improvements
• Responsible for making modifications and enhancements to the existing system
• Creating lab usage policies and guidelines and ensure the information is disseminate among the lab users
• Creating user documentation, best practice guidelines with related to using Acer system and conducting related user trainings

Environment: - Visual Studio 2012, ASP.NET, Windows Server 2008 R2, Windows 7, Microsoft Office.

Confidential

QA Tester / Support Engineer

Responsibilities:

• Gather and review user requirements with vendor packages to select the suitable equipment for the client
• Assist with workflow diagrams, network diagrams and research on compatibilities of the systems
• Assist the project manager and the development team with selecting the most suitable and affordable solution for the client
• Install additional required processors and memory to meet the client specification
• Install the server and storage unit on location with the assistance of the team
• Run diagnostic checks on all the deploying server equipment on office and on site
• Configure the hard disks to the requested RAID levels
• Install Windows Server 2008 R2 and configure as requested on the servers to run the hospital applications
• Perform the performance testing of the applications installed into the servers including the network and report to the Project Manager
• Install and configure the virtual servers to the client requirements
• Install the magnetic tape drive and schedule backup procedures with the team
• Creating user documentation and manuals for the users involved in the system
• Follow up maintenance and troubleshooting after installation

Environment: - Windows Server 2008 R2, Windows 7, Microsoft Office, HP SmartStart, VMWare VSphere 5, Hyper-V