Test Cases System
Resume:
Nayan Patel
Validation Analyst
Email : *****.***@*******.***
Professional Summary:
Consistent Top Performer and Task Master with around8 years of Experience in field of Validation in FDA regulated Environment with concentration in Computer System Validation (CSV), Laboratory Instruments and Medical Device
Experience in computer systems validation as per FDA regulations including 21 CFR Part 11 electronic records, electronic signatures requirements as well as ICH Guideline.
Experienced in the creation and execution of Validation deliverables for a System mainly; Validation Master Plan (VMP), User Requirements Specification (URS), Functional Specification, Configuration Specification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), and Requirements Traceability Matrix (RTM).
Validated the Laboratory Instrument(s) with preparing documentation of all the key deliverables of the validation life cycleused for cGMP and 21 CFR part (11, 210, 211 & 820),
Worked on the Test Method validation for the analytical Laboratory Instruments used for cGMP operations in Quality Control and Research & Development departments.
Good understanding of Testing Life Cycle (TLC) and Software Development Life Cycle (SDLC).
Extensive work experience in FDA regulated environment andfamiliar with FDA Good Manufacturing Practices (GMPs), and Good Laboratory Practices (GLPs),
Extensive experience of performing the Gap Analysis and Risk Analysis for the system/products in GMP/GLP environments.
Experience in validating the cloud computing application like Infor’s Enterprise Asset Management and PV Works; Pharmacovigilance system.
Worked with suppliers providing SAAS application and the third party host namely; Amazon Web Services and Pound host residing the client’s CGMP data on their servers.
Extensive experience with Laboratory Information Management System (LIMS), Enterprise Asset Management (EAM), Novatek Stability Management System, PV Works and Adverse Event Reporting System (AERS).
Experienced in change control management and Corrective Action and Preventive Action(CAPA).
Experience working with Electronic Document Management system (DMS) like Ennov, Documentum, SharePoint to archive and retrieve documents.
Exposure in different testing strategies including automated and manual testing strategies.
Excelled in crystallizing user requirements effectively, resulting in project lifecycles.
Motivated self-starter with exceptional team building and interpersonal skills
Ability to adapt and learn new tools, techniques and approaches
Excellent technical, analytical, leadership and communication skills.
Skills:
Validation
21 CFR part (11, 210, 211 & 820), Validation Master Plan (VMP), Functional Specification (FS), Design Documents (DS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Plans, Requirement Traceability Matrix
Laboratory Instruments
TOC, FTIR, UV Vis Spectrophotometer, Texture Analyzer, Densitometer, Vitek 2 System
Application
Enterprise Asset Management (EAM), PV Works-Pharmacovigilance Software, LabwareLIMS,Oracle Argus Safety Suite,TrackWise (Sparta Systems).
Adobe
Adobe Acrobat 7-10, Adobe Photoshop.
SDLC
Waterfall and V Model
Platform
Windows, OS MAC, UNIX
Microsoft Office
2003-2010 (Word, Excel, Access, Front Page, Power Point, Photo editor).
Professional Experience:
Virbac Animal Health - St.Louis, MO Aug 2015 – Present
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Virbac Animal Health - St.Louis, MO Aug 2015 – Present
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Virbac Animal Health – Bridgeton, MO Aug 2015 – Present
Validation Consultant
Virbac is the largest Veterinarian Pharmaceutical Company manufactures the wide range of Veterinary products for health and well-being of dogs, cats and other companion animals. Products are mainly in the areas of endo- and ecto-parasiticides, dermatology, dental care, antibiotics, behavioral health, endocrinology, euthanasia, nutrition and urology. My responsibility was to manage and execute multiple Validation projects of Cloud Computing SAAS/Hosed applications, COTS (Commercial Off the Shelf) Computer Systems and Laboratory Instrument systems as listed below.
Computer Systems and SAAS/ Hosted Cloud Application
oEnterprise Asset Management (EAM), Version 11.2 ( Data Stream)
oPV Works, Phamacovigillance Software, Version 4.2.1
oNovatek’s Stability Management System (Nova-SMS), Version 3.1
oeTraininfo - Training Management System, Version 6.1.0
oGlobal Visoin’sArtproof,Scanproof&DocuProof Inspection System
Laboratory Instruments
oSievers 900 Series Total Organic Carbon(TOC) Analyzer
oShimadzu TOC-L Analyzer with the SSM-5000A Solid Sample Module, and Autosampler (ASI-L) System
oHitachi U-2910 UV-Vis Spectrophotometer
oStable Micro Systems Texture AnalyserTA.XTplus
oDensitometer, Model DDM 2910 Digital Density Meter
oFTIR.
oVitek 2 Compact System; Vitek 2 Instrument, Vitek 2 Computer system and DensiCHEK™ Plus
Responsibilities
Conducted the business meetings with the system owner and stake holders to identify the scope of the project and its timelines.
Interacted with the System Owner to gather the user requirements for the Computer System and Laboratory Instrument system(s) as per the business needs and specifications.
Developed the Validation Plan for the Computer Systems and Laboratory/ systems that details an overview of the validation effort strategies following GAMP5 guidelines.
Performed the Computer and Laboratory Instrument System Evaluation for the GxP/non-Gxp determination, 21 CFRPart 11 applicability, GAMP category and risk factor for product quality and Patient Safety.
Performed Risk analysis and documented FMEA(Failure Mode Effective Analysis) to identity Direct/Indirect impact on product quality
Assisted in configuration of the GAMP category 4 COTS software system(s) with following as per the business process flows and user requirement specifications.
Documented and captured the configuration of the system(s) in the configuration specification document.
Worked with vendor/supplier to finalize the Service Level Agreement to meet client needs for the SAAS/Hosted cloud software application detailing aspects data management, storage, processing and security for using third party host services. This must include all the aspects but not limited to the following; Disaster Recovery Plan, Network Infrastructure Components, Virus protection and firewalls, Downtime (NOT TO EXCEED .1% (.001) per annum, not to exceed one hour per event,) and outage of cloud/servers at host's location, Patch/fix scheduling & notifications, Response time in critical situation, Data Security & Data Integrity, and “Need to Know” access to Encryption keys for databases.
Reviewed the supplier’s Qualification for the system and ensure it’sin compliance with the following the client policy of cGMP and cGLP regulations.
Authored validation protocols of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification(PQ) for the computer software applicationsand Laboratory systems.
Validated the analytical test method that will be used for the Laboratory Instrument to obtain analytical results of repeatability, reproducibility and accuracy.
Executed IQ/OQ/PQ qualification test scripts and authored its summary reports for the system.
Reported the deviations occurred during the execution following the protocol guidelines and company’s policy.
Initiated the CAPA for the opened deviation that details the investigation, root cause of the issue and identify the needed corrective and preventive actions to resolve the problem.
Developed Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases.
Authored and Documented the Validation Summary Report (VSR)
Involved in preparing Validation documentation considering all aspects of the Computer Systems SDLC and Laboratory Instrument system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR Part 11, 211 & 820 .
Reviewed and verified whether System’s (Lab Instrument/Computer) Validation deliverables & Protocols including IQ, OQ and PQ’s are in compliance with cGMP.
Assisted in developing the computer system validation standard operating procedure according the to the GAMP5 guidelines
Collbrated with the Quality Assurance and Quality control team to ensure that the system meets all the industry and regulatory requirements for its intended use in cGxP environment.
Prepared the Administration and Operational Standard Operating Procedure for the systems.
Virbac Animal Health - St.Louis, MO Aug 2015 – Present
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Teva Pharmaceuticals, West Chester, PA May 2013 – July 2015
Validation Consultant
Teva pharmaceutical industries is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals as well as active pharmaceutical ingredients. As a Validation Specialist I was responsible for validating the Migration of Project Management and Operations, which is a project of validating migration of the entire active and historical client projects from legacy System Zavacor a Clinical Data Management System to LabWare LIMS V6.
Responsibilities:
Involved in interaction with Business Owners, System Owners, Business Analyst, and Project Managers to describe user requirements and functional design specifications.
Created Validation Master Plan (VMP), Requirement Traceability Matrix, Requirements Specifications, System Design/Configuration Specification, Validation Summary Report.
Interacted with Business and Information Technology personnel’s to gather the requirements and create the Requirements.
Validating System Software and quality assurance programs including Standard Operating Procedure (SOPs) governing validation activities; templates for validation related documentation such as validation protocol and plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
Responsible for creating, reviewing, approving and, executing test plan and test cases.
Prepared documentation for all aspects of computer systems validation.
Involved in functional requirements specifications and other critical system documentation.
Analyzed test results and attached evidence to ensure that user requirements and functional specifications are effectively met.
Validated Standard Operating Procedures to ensure compliance with FDA regulations namely 21 CFR Part 11.
Developed Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases.
Made deviation investigations of test case failures or bugs and resolved them.
Used TrackWise to provide secure access to authorized users to initiate new problems and incidents of any type into the system- restrict users to be able to create new records only for their relevant areas and responsibilities.
Related electronic files were attached as reference documents using TrackWise so that they can be reviewed along with the overall request.
Involved in developing local level Standard Operating Procedures (SOPs)
Involved in performing GAP analysis of the current system.
Baxter Healthcare, Deerfield, IL Feb 2012 – Apr 2013
Validation Consultant.
Baxter is a global leader in delivering critical therapies for life-threatening conditions. All Baxter technologies are related to the blood and circulatory system. Project involved was migration of all the systems from P&G. I was involved in validating complete package of Oracle Argus Safety Suite after Configuration and at COTS level, CTMS and other small GxP and non GxP systems.
Responsibilities:
Documented IQ, OQ, and PQ for different modules of Oracle Argus Safety, My Custom Reports and Oracle discoverer.
Developed and maintained Validation Master Plan (VMP).
Ensured the process was in compliance with FDA rules and regulations.
Developed Standard Operating Procedures (SOPs) based on the business requirements gathered for validation plan, test scripts and test procedure.
Executed the IQ’s, OQ’s and PQ’s and coordinating simultaneously with the QA department.
Documented the test scripts and analysed them to check for compliance with 21 CFR part 11 rules of FDA.
Assisted in developing processes for the Adverse Event reporting system that includes; Data enrty for new adverse event case, Data entry for Complaints and Enquiries, Triage case, VEDDRA Coding, Investigation, Reporting (single Case report or multiple case report), and Regulatory Report Approval and Report submission to FDA
Developed Requirement Traceability Matrix (RTM) to track User and Functional requirements.
Actively participated in requirements and design review.
Involved in reviewing Corrective and Preventive Action (CAPA) and drafting remediation plans for the project management approval after the GAP analysis.
Created Validation Summary Report (VSR) to summarize overall validation activities.
Boston Scientific, Natick, MA Jan 2011 – Jan 2012
Validation Analyst
Boston Scientific is a worldwide leader in the development, manufacturing and marketing of medical devices that advances the practice of less-invasive medicine. As a Validation Analyst I was involved in an upgrade of the TrackWise system from version 7.0 to version 7.9. There were many changes made to the TrackWise system before, but the proper documentation was missing, so I was responsible to check all the updates and document them according to the current system. I was also involved in validating the TrackWise 7.9 system.Implemented TrackWise 7.9 as a complete end to end solution to address the implementation of Product Complaints Handling, Investigation, FDA(Food and Drug Administration) reporting, Risk Assessment, Trending and CAPA (Corrective & Preventive action).
Responsibilities:
Involved in TrackWise version 7 and 8 configurations thatincludemodules configuration and support.
Gathered business requirements in compliance with 21 CFR part 11
Followed all the policies and procedures involved in the manufacturing operations in the development of catheters
Involved in validating the TrackWise CAPA (Corrective Action Preventive Action) BusinessWorkflow
Reviewed and edited User Requirement Specification (URS), Functional Requirement Specification (FRS), and Design Specification (DS) of TrackWise.
Assisted the project manager in documenting SOPs, validation protocols (IQ, OQ, PQ) in the development of catheters in production phase.
Created Test readiness review documents and Validation implementation check listdocuments for TrackWise application.
Prepare CAPA plan, write test cases, test scripts, test summary reports for overall product, part wise assessment and improvement, report concerns if any to the suppliers
Involved in preparing documentation for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR Part 11
Provided engineering support to the operational issues based on the existing procedures
Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are catered by the application
Extensively used enterprise data management platform Documentum for maintaining validation life cycle documents
Performed production data analysis and suggested process parameters for process optimization, process control and product development
Documented the Validation Summary Report (VSR)
Aurobindo Pharma, Hyderabad, India Jul 2009 – Dec 2010
Validation Analyst
Aurobindo is one of the largest ' Vertically Integrated ' pharmaceutical companies in India, Aurobindo has robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil for both APIs & Formulations. This project was Concentrated Mainly in Preparing Guidelines, Integrating and Validating Analytical Laboratory Equipment’s interfaced to LabWare Lab Station in Compliance with cGXP.
Responsibilities:
Validation analytical as GC, HPLC, Autoclaves and Incubator in compliance with FDA regulations.
Conducted testing for Functionalities of the Chromatography data software that was used for High Performance Liquid chromatography (HPLC) and analysed result to ensure compliance with 21 CFR Part 11.
Performed GAP analysis and proposed remediation plans
Designed and maintained Standard Operating Procedures (SOP’s)
Interface validation and calibration activities with the GMP operations, QC and QA groups.
Attended TrackWise trainings organized by Sparta Systems
Developed Validation Master Plan (VMP).
Prepared Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols
Maintained Requirement Traceability Matrix (RTM) to cross reference the functionality to the required test cases and scripts
Executed and reviewed the test scripts & Operational Qualifications for the formal validation with implementation of cGMP, cGLP
Verified whether all validation protocols including IQ, OQ and PQ’s are in compliance with cGMP.
Participated in the writing of validation test summary report.
Maintained the Required Traceability Matrix (RTM).
Coordinated the validation activities with departments, while providing support services.
Reviewed existing client templates and updated the templates to improve the quality of documentation.
Created and reviewed requirements specifications documents to ensure all business processes are captured correctly and are testable.
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