Vandanabahen Patel
Fargo,ND
Summary
Over 12 years of experience in Pharmaceutical Industry working as a Validation Analyst in Validating the integration projects, EDMS and ecommerce applications in Compliance with all the GCP, GLP, GMP and 21 CFR PART 11 Rules. Knowledge and implementation experience of Testing Principles and Configuration and Change Management Disciplines. A good understanding of the principles of Software Validation in Regulated Industries including 21 CFR Part 11, GxPs regulations. Expertise in developing Computer System Validation Plans, Test protocols and validation report and document test results in accordance with FDA standards. Experience in all phases of software development life cycle (SDLC), Computer system Validation and stages of testing applications in Compliance with all the GCP, GLP, GMP and 21 CFR PART 11 Rules. Experience of developing various documentation and reports for the application in accordance with 21 CFR PART 11. Expertise in Sox testing using Metric Stream.
Overview
13
13
years of professional experience
Work History
Validation Analyst
Thermo Fisher Scientific
Middleton, WI
05.2018 - Current
- Led the team to deliver the projects on-time
- Provide guidance and support to junior team members in validation activities
- Manage the Projects-on-Project dashboard and provide weekly status reports to the Stakeholders
- Introductory and ongoing support of software systems and/or laboratory instrumentation and enterprise systems
- Validation supports new releases and modifications to applications throughout the software development lifecycle
- Preparation, review, and completion of validation documents; including Change Control, Risk Assessment, Installation and Operational Qualification, Performance Qualification, Test Cases, User Requirements and Validation Summary
- Accurate execution of test scripts to produce evidence that the system consistently performs its intended function(s)
- Write/revise the system SOPs within Veeva Quality
- Author incident records for any issue observed during the qualification
- Author Non-Conformance and Deviation occurred during qualification
- Respond to the QA audits or address any nonconformance/quality events within PARTner Application.
- Participated in peer reviews of test plans, scenarios, scripts. to ensure their accuracy prior to implementation.
- Evaluated the systems for compliance with current regulatory requirements such as 21 CFR Part 11 and Annex 11 guidelines.
- Worked with Agile and Scrum methodologies to accomplish project milestones and meet demanding timelines.
Validation Specialist
Pfizer
Collegeville, PA
02.2016 - 05.2018
- Responsible for performing GAP analysis for Computer System Validation methodologies category
- Working closely with BT Site lead to gather site SOPs for GAP Analysis worksheet provide guidance for revise site SOPs to align with Global SOPs
- Experience creating Change Control using Trackwise
- Provided remediation action by performing GAP analysis
- Create and approve Project summary report in PDOCS
- Responsible for updating BT scheduler tool for Periodic Review, UAR and Disaster Recovery Plan of BT applications
- Involved in updating checklist for Audit of Periodic Review, UAR and Disaster Recovery Plan of applications
- Responsible for collecting data for GMP application of Hospira sites and fill out Computer Compliance Assessment Form (CCAF)
- Ensured that all systems comply with applicable regulatory guidelines such as FDA 21 CFR Part 11.
- Responsible to work with offshore Hospira Site’s Business Technology Site Lead to collect information for validation documents, GAMP category, Regulatory issues questionnaire, application information and location of validation documents for all GMP application across worldwide sites of Hospira
- Worked closely with manager to update application tracker for Hospira applications using SharePoint
- Review completed Computer Compliance Assessment Form.
Validation Specialist
Johnson & Johnson
Skillman, NJ
04.2013 - 12.2015
- The project involved implementing a new e-commerce portal to be launched in North America to replace the existing portals for Medical Device and Diagnostics and consumer products sectors
- Provide support and guidance to Business team and IT Risk Assurance team and collect requirements to develop proper system development lifecycle (SDLC) documentation
- Organize all project documentation on the project’s secure server and collaborative portal
- Responsible for creating and updating supporting documents Compliance Plan, User Requirement Specification, System Test Protocol, User Acceptance Test Protocol, System test Report, Compliance Report and more for the application
- Expertly determine the gap between documented requirements and functionality of legacy applications and technical design specifications through Traceability Matrix documents
- Ensure application requirements are captured within HPQC
- Implement the use of standard templates to create up to date SDLC documents
- Supervise the appropriate review, approval, and completion of all steps for the document
- Produce documentation regarding any updates and modifications to the system
- Track requirements in Traceability Matrix using QC tools
- Responsible for creating Compliance Report prior to release for production
- Assist in creating and executing Production checklist prior to Go-Live
- Execute SoX testing for application and document test results.
- Documented entire validation process and recorded all changes.
Validation Specialist
Sanofi Pasteur
Swiftwater, PA
03.2011 - 12.2012
- Responsible for writing and execute cleaning validation protocols for processing and filling equipment
- Responsible for writing validation reports for cleaning development and validation
- Use LIMS application to report data for cleaning validation
- Coordinated testing schedule with impacted area managers and quality control based on project need
- Created department standard operating procedures
- Performed notebook studies & ran TOC samples on TOC analyzer
- Responsible to Investigate and troubleshoot validation problems
- Responsible to ensure the environment of vaccine formulation meets the requirement of the cGMP
- Execute Dynamic and Static Environmental Monitoring
- Execute Viable, Non-viable and Settling Plates
- Submit the samples to QC chemistry lab
- Execute EMPQ for Retrofit Project
- Follow accurately oral & written procedures in operating production equipment & performing Processing steps
- Assist in review & creation of operation documents by providing input to technical Composition of document.
Education
MBA -
University of North America
03-2015
Master of Science -
Stevens Institute of Technology
03-2011
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Science
10-2007
Skills
- Test Plans and Test Methodologies
- Cross-Functional Team Collaboration
- Scenarios and Use Cases
- Test Procedure Documentation
- Team Mentoring
- Root Cause Analysis
- Compliance Testing
- Project Management
- Agile and Waterfall Methodology
- Documentation Skills
- Requirements Analysis
Timeline
Validation Analyst
Thermo Fisher Scientific
05.2018 - Current
Validation Specialist
Pfizer
02.2016 - 05.2018
Validation Specialist
Johnson & Johnson
04.2013 - 12.2015
Validation Specialist
Sanofi Pasteur
03.2011 - 12.2012
MBA -
University of North America
Master of Science -
Stevens Institute of Technology
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Science
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