SUMMARY

• He comes with 14+ years of hands - on experience working in Biotech/Immunotherapy/Pharmaceutical/Device Manufacturing and Clinical and Non-Clinical Sample Management Groups
• Lead CS validation effort, including planning, managing, and coordinating validation activities.
• Performed Risk Based Validation for COTS, Configured and Customized software systems
• Good understanding of 21 CFR Part 11, Annex 11, 106, 107, 210, 211, 820 (QSR) and ISO 13485:2003
• Expert in authoring and delivering validation documents during different phases of the Software Development Life Cycle (SDLC)
• Owned and managed validation and implementation of medium to small scale projects.
• Quick learner, able to use new tools and can start on projects hit the ground running
• Adaptable individual with excellent problem solving and communication skills who takes ownership of all assignments and areas of responsibility
• Strong team player with the ability to build positive and collaborative relationships.
• Consistently delivered in each project on time, meeting or exceeding client expectations

TECHNICAL SKILLS

• Validation Master Plan, Data Migration Plan, Change Control, Risk Assessment, Requirements Specification, Design Specification, Installation Qualification, Operation Qualification, Performance Qualification, Requirements Traceability Matrix, Training Plan, Deviation/Exception Report, Validation Summary Report and SOP
• SDLC methodologies such as Rational Unified Process (RUP), Waterfall and Spiral Methods
• SQL queries and using DMBS tools like TOAD to evaluate data
• Analyze and report bugs using Defect Tracking Tools and understand Defect Life Cycle testing Oracle Forms, .NET, Java, XML and Web based applications programming languages like PL-SQL, Java Core/Swing/JSP and Node JS; web automation testing tool like Selenium WebDriver and REST Webservices testing using Postman and REST Assured; and SAP Business Objects Reports

PROFESSIONAL EXPERIENCE

Confidential, Santa Monica, CA

CS Validation Engineer III

Responsibilities:

• Create Validation Plan and define validation strategy for Enterprise Computerized Systems including Instruments and Equipment controlled by software.
• Perform Quality Risk Assessments and Impact Assessments.
• Manage consultants to perform and deliver Validation deliverables.
• Train and coordinate validation testers during qualification effort.

Quality Engineer

Responsibilities:

• Quality Approver for ongoing production support for several GxP systems.
• Review and Approve validation documents and other related documents for accuracy and compliance to procedures.
• Provide validation guidance and support for the development and implementation of computerized systems and instruments.
• Review change assessment, perform validation impact assessment and participate in CCRB meeting for changes to GxP systems.
• Participate and provide guidance during in risk assessments for several projects.
• Evaluate, analyze, and approve deviations and changes in order to guarantee that these are well documented and that corrective action(s) are completed.
• Participate in Validation Forums to collaborate with Validation/Quality teams/groups to ensure consistent validation approach.
• Coach and mentor new team members in order to improve team performance and individual development.

Confidential, Thousand Oaks, CA

Senior Validation Analyst/Change Owner

Responsibilities:

• Validated Release/Breakfix projects for Holistic Lab Execution Environment - Electronic Lab Notebook (HLEE-ELN) and Instrument Data Acquisition (HLEE-IDA) systems
• Defined validation strategy and created/updated validation documents like VP, RS, RD, DS, Qualification protocols, RTM and VSR
• Owned Change Management activities - Created, owned and managed change records in CCMS and ISM
• Conducted weekly Change Control Board meetings to ensure change records are opened, executed and closed within the implementation date
• Coordinated Review and Approval of documents between various stakeholders within tight timelines
• Coordinated with the QA team to ensure testing (Dev, Integration, Regression, Functional and NFR) is completed at the end of each Sprint and build released for formal testing

Confidential, CA

Validation Lead

Responsibilities:

• Planned and managed the Qualification of the Colocation data center
• Developed the Qualification Plan and the strategy for the project
• Created additional system assessments/documents to bridge the gap between requirements defined by the organization and industry standard validation requirements
• Authored all the validation documents for the project
• Resolved deviations from the proposed plan and mitigated risks by performing risk assessments where required
• Assessed and proposed Standard Operating Procedures required for the colocation data center
• Guided the project team to follow a defined process during plan, build, implementation and release
• Worked with Quality to open a Non-Conformance for documenting the unqualified state of the Validation environment
• Completed the Corrective Action/Preventive Action for bringing the Validation Environment into a controlled state.
• Trained the project team on Validation and Quality requirements

Confidential, Irwindale, CA

Independent Quality Reviewer

Responsibilities:

• Assisted the Compliance manager on several projects by providing guidance on validation to IT teams
• Assessed compliance and quality requirements for new projects
• Guided the project team to follow a defined process during system development, implementation and maintenance
• Guided the project team to create the required deliverables and review the completed documentation
• Involved in revising procedures and developed training content for all users on the updated procedures

Confidential, Menlo Park, CA

Validation Lead

Responsibilities:

• Defined validation strategy, managed validation timeline, coordinated with vendor's validation team and closed the validation effort
• Assessed vendor provided validation and process documents to support the vendor audit process
• Ensured vendor provided project validation documents meet company's quality requirements
• Authored Functional and Design Specifications for custom interfaces
• Managed validation testing effort including defect resolution
• Collaborated with IT and Business teams to develop SOPs
• Defined the validation strategy, managed the validation timeline and closed the validation effort
• Educated team members about the validation methodology
• Reviewed initial project validation documents, incident tickets, changes, upgrades, support processes etc. to assess the gaps and create GAP Assessment Report
• Authored validation documents for the project (System Requirements Specification, Risk Assessment, Design Technical Specification, OQ/PQ, RTM, etc.)
• Managed validation testing effort including defect resolution
• Provided validation guidance for retrospective validation of MES (Camstar Medical Device Suite) for chip manufacturing
• Worked with SME to understand the business process
• Assessed compliance and quality requirements for the system
• Reviewed and assessed existing documentation created by the vendor and defined a risk-based validation strategy
• Guided the project team to create the required deliverables and review the completed documentation
• Ensured the completion of validation effort within the project timelines

Confidential, Westlake Village, CA

Validation Lead/Business Analyst

Responsibilities:

• Served as BA/Validation Lead to automate sample testing between 2 manufacturing facilities
• Mapped AS-IS Workflow and proposed several TO-BE workflows and determine Gaps
• Worked with the technical team to configure and implement the functionality
• Developed several validation documents
• Served as Developer/Validation Lead to develop pseudo code and validation documents for the enhancement
• Designed and developed the customization using PL-SQL
• Collaborated with JDE and WebMethods team to test and validate the enhanced interface
• Served as Developer/Validation to develop pseudo code and validation documents for the customization
• Designed and developed the customization using PL-SQL
• Validated the enhancement
• Managed validation activities for the entire project
• Collaborated with Technical team and Quality organization to define the implementation and validated strategy
• Created validation test documents (IQ/OQ/PQ) in HP Quality Center
• Qualified the Infrastructure platform prior to validating the application
• Authored several validation documents
• Resolve test defects and prepare validation summary report

Confidential, Evansville, IN

Senior Validation Specialist/Business Analyst

Responsibilities:

• Validated a new workflow/configuration for batch printing of Manufacturing Master Batch Records in Syncade DCA (Electronic Document Management System)
• Responsible for defining a Risk Based Validation Strategy as well as Migration Strategy
• Developed the Validation Master Plan (VMP) and the Data Migration Plan (DMP)
• Responsible for planning and scheduling tasks for the delivery of validation documents
• Performed business analysis function by interviewing and gathering requirements from the business users and responsible for updating the System Requirements Specification
• Ensured validation activities were followed as per the SOPs
• Authored IQ/OQ, in HP Quality Center, to setup and validate new workflow in the system
• Resolve test incidents and ensure completeness of validation package
• Authored IQ, OQ, PQ Summary Reports, Data Migration Summary Report and Validation Summary Report

Confidential, Thousand Oaks, CA

Validation Analyst

Responsibilities:

• Performed development testing on statistical summary tables and figures for different study scenarios and parameters
• Authored OQs to validate the reporting tool
• Coordinated and managed the test case execution
• Documented Test Incidents/Deviations and ensured the resolution of issues
• Actively worked with the SME to clarify and refine User Requirements
• Worked with different project teams for testing Interfaces with different systems
• Took ownership of testing several modules in the system including interfaces and worked with the developers to clarify the Functional and Design Specification for each module
• Actively involved in development test management including defects tracking and status reporting
• Planned, created and developed test requirements, test plan (OQ) and test cases
• Hands on effort in Data Validation from both front-end application and back-end database

Confidential, Westlake Village, CA

Validation Analyst/Application Support

Responsibilities:

• Responsible for opening change requests, asses risks and deliverables affected by the change
• Gathered requirements, developed Use Cases and demonstrated prototypes
• Authored Functional and Design Specification (FDS) for several enhanced modules
• Designed and developed IQ and OQ test cases for release projects based on FDS and release notes
• Developed a customization in PL-SQL for results calculation in SQL*LIMS
• Responsible for execution of System Validation documents and prepare summary reports
• Took ownership of validating the new tool
• Performed exploratory testing and identified potential issues with the tool
• Interacted with the developers in communicating the defects and retesting the updated builds
• Developed the Installation and Performance Qualification (IPQ)
• Developed exception reports and the Validation Summary Report

Confidential, Jersey City, NJ

QA Tester

Responsibilities:

• Tested a web-based clinical/non-clinical budgeting system
• Generated automated test scripts for regression testing of the application using automated testing tools namely, using TestDirector for Quality Center and QuickTest Professional

Confidential, West Point, PA

Validation Analyst/Tester

Responsibilities:

• Validated the decommissioning of a Mainframe system and migrate archive data to Oracle database with front end in MS ACCESS
• Developed validation documents for decommissioning the Mainframe system
• Actively involved in the data migration process
• Created Integration and Acceptance Test Plan (ATP) for the front-end system