Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Amrita Kaushal

Amrita Kaushal

Ghaziabad

Summary

Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Hardworking employee with customer service, multitasking and time management abilities. Devoted to giving every customer a positive and memorable experience.

Overview

6
6
years of professional experience

Work History

Computer System Validation Analyst

Cognizant Technology Solutions
Noida
11.2021 - Current
  • Experience in Quality and Compliance with hands-on computer system validation experience.
  • Good Knowledge in GAMP5, 21 CFR Part 11 and EU Annex 11.
  • Perform assessments of computer systems and processes for Life Sciences clients(compliance with internal procedures, leading practices and regulatory requirements).
  • Create/review CSV deliverables like URS, QPs, SOPs, IQ/OQ/PQ, RTM, DS, FS, and Validation Plans and Reports.
  • Experience in GxP Periodic Review, Deviation Management, CAPAs, Change Management
  • Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems.
  • Experience in FDA regulated environment with good understanding of cGXP standards and risk validation approach.
  • Experience in training validation validation resources.
  • Experience in performing assessments based on 21 CFR Part 11 and Annexure 11 requirements.

Validation Analyst

Tata Consultancy Services
Noida
11.2017 - 11.2021
  • Knowledge of GAMP5, Worked on GxP Regulated Systems as Validation Lead in Life Sciences and Pharma
  • Discussion for Quality Assurance Agreement/ Technical Agreements and Confidentiality Agreements./ Participated in FRA for new projects and help in finalizing High Level Classification of the application.
  • Assisted with performance of impact assessments and provided final review of investigation, Deviations and Corrective and Preventive Actions.
  • Evaluated assessed and reviewed proposal Change Controls; verified their implementation and closure.
  • Help in completing GxP Periodic Reviews verified their implementation and closure.

Education

Master of Science - Computer Science

Dayalbagh Educational Institute
Agra
05-2017

Skills

  • Root Cause Analysis
  • Deviation Management
  • CAPA Management
  • GxP Periodic Review
  • Change Management
  • Audit Support
  • Report Preparation
  • Documentation And Reporting
  • KPI analysis
  • Regulatory Compliance

Languages

Hindi
First Language
English
Upper Intermediate (B2)
B2

Timeline

Computer System Validation Analyst

Cognizant Technology Solutions
11.2021 - Current

Validation Analyst

Tata Consultancy Services
11.2017 - 11.2021

Master of Science - Computer Science

Dayalbagh Educational Institute

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Amrita Kaushal