Vaishali T.

Sr. Computer System Validation Engineer at Kabir Technologies
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Contact Information
us****@****om
(386) 825-5501
Location
Gujarat, India, IN
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Credentials

  • Certified Product Specialist
    Tata Consultancy Services
    Sep, 2023
    - Sep, 2024
  • Complete Software Testing Course (QA Testing )
    Udemy
    Mar, 2022
    - Sep, 2024
  • Manual and Basic Automation testing
    STAD Solution
    Mar, 2022
    - Sep, 2024
  • Introduction to Programming Using Python
    Great Learning
    Dec, 2021
    - Sep, 2024
  • Introducing SAP Fieldglass Assignment Management
    SAP
    May, 2021
    - Sep, 2024
  • Lean Six Sigma Yellow Belt Certification
    6sigmastudy - The global certification body for six sigma certifications
    Jun, 2020
    - Sep, 2024
  • World of Compliance Overview (abridged)
    FDA
    Jun, 2020
    - Sep, 2024
  • Computer System validation For Pharma and Biotech
    ISPE India Affiliate
    Nov, 2014
    - Sep, 2024
  • Industrial Automation Trainning
    NCVT
    Jul, 2013
    - Sep, 2024
  • Foundation of GMP : Data Integrity and Computer System Validation
    US Pharmacopeia
    Jul, 2007
    - Sep, 2024

Experience

  • Kabir Technologies
    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Sr. Computer System Validation Engineer
      • Jun 2019 - Present

      +Executed QC systems, Laboratory systems. Prepared documentation based on regulations and compliance. +Involved in Qualifying the Client/Server applications according with 21CFRpart11 requirements like Security, Audit Trail etc. +Executed SAP system's modules, Machine Translation system. +All the documents managing on the system portal. +Executed DocuSign system with Compliance part. +Executed Machine Translation system and run the Python scripts as require in the application. +Documents prepared for ERP system based on execution and detailing. +Responsible collect the details of the systems, prepared documents, co-ordinate with different dept. and take a approval form them for validation activity. Show less

  • Arizona Automation and Technology
    • Sr. Project Engineer Computer Systems Validation
      • Aug 2017 - May 2019

      +Marketing for PLC, CSVs systems Validation. +Arrange meeting with client and provide information for validation project completion with timelines and information of documentation based on SDLC V model, 21 CFR Part 11 Compliance & EU Annexure 11 and Gamp5Guidelines. +Completion of meeting approvals from clients. +Prepared Audit Agenda. +All the require documentation, SOPs, Training Material developed for Vendor Assessment. +Developed documentation and Execution done in PLC Systems (Manufacturing Machineries GEA,IMA,ACG Pam, Praj, Shauter etc.), CSV Systems (Perking Elmer, Shimadzu, KTA Reader etc. ), Spread sheet developing, and validation in Pharmaceutical. +Provide a training to new candidates and support at client site. Show less

  • IVY WORKS
    • Netherlands
    • Human Resources Services
    • 1 - 100 Employee
    • Validation Engineer
      • Mar 2016 - Dec 2016

      +Executed web based system and developing a validation document i.e.: Art Work Management System +Spreadsheet developing, validation execution and documentation. +Achievements received for Spreadsheet Validation. +Execution and document preparation based on V-Modal done in PLC base system (PLC+SCADA+HMI Systems) i.e.: Tablet maker system, Labeling Machine, Auto-coater Machine, Building Management system, Check Weigher , Temperature Mapping Machine and many more. Sites visit accordingly. +All the validation document signed off from the client accordance with the department. and provide final executed protocols with taken evidence submit to the client. +Responsible for collecting details of the system based on that procced for the validation documentation. after completion of the validation project approved MOM from client. Show less

  • DHA Technologies
    • India
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Project Engineer
      • Aug 2014 - Oct 2015

      +Developing Validation Documents based on SDLC V-Model. +Creating and Reviewing documents based on cGMP, GxP:Compliance Guidelines and Quality, 21 CFR Part 11, ISPE-Gamp5 Guidelines, Data Integrity, SDLC V modal, Validation documentation based on GDP VMP,URS,FRS,CS,DS,IQ,OQ,PQ,TM,VSR. +Executed automation(PLC+HMI,SCADA) system. i.e.: Compression machine, Fluid Bed Dryer, Environment Control System and many more. +Software Systems HPLC, GC, Chromeleon, Zetasizer, Empower etc. +Measuring a Set Parameters & functional Value, Digital and Analog I/Os. +Executed System in Production Environment. +Sites visit accordingly. +All the validation document signed off from the client accordance with the department. and provide final executed protocols with taken evidence submit to the client. +Responsible for collecting details of the system based on that procced for the validation documentation. after completion of the validation project approved MOM from client. +Responsible for the calibration of instruments like multimeter, thermohydrometer, calibrator etc. and also record on site instruments availability with the instrument due date. Show less

Education

  • Sabar Institute of Technology For Girls
    Bachelor's Degree, Instrumentation & Control Engineering
    2011 - 2014
  • Scientific Education Group
    Bachelor of Science (B.S.), Mathematics
    2009 - 2010

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