Summary
Overview
Work History
Education
Skills
Certification
Interests
Timeline
Generic

Shubham Jain

Consultant - Business Technology
Ahmedabad

Summary

CSV and Manual Testing professional with 3+ years of experience in the pharmaceutical and life sciences domain. Proficient in CSV validation documentation (URS, OQ, PQ), functional and manual software testing, and SaaS-based system support. Experienced in ensuring compliance with GAMP 5, 21 CFR Part 11, and QMS standards. Actively seeking opportunities where I can contribute my expertise in validation and testing to ensure quality and regulatory compliance. Eager to learn new technologies and methodologies.

Overview

8
8
years of professional experience
7
7
years of post-secondary education
6
6
Certifications
3
3
Languages

Work History

Consultant - Business Technology

Sarjen Systems Pvt Ltd.
01.2022 - 03.2025


  • Responsible for understanding and analyzing requirements from client and stake holders and Process URS (User Requirement Specification)
  • Handling CSV activities of preparation & Execution of CSV documentations such as URS, FS, DS, RA/IA, RSA, OQ (Operational Qualification) and PQ (Performance Qualification) protocols and reports, Tracebelity Matrix.
  • Experience in Change Management, CAPA, Solution Implementation.
  • Testing support in drafting and executing the Test Script & Test Cases.
  • Quality Assurance of CSV, 21 CFR Part 11, GAMP 5 and QMS.
  • Efficiently Handling SaaS (Software as a service) for Clinical Trial Management.
  • Product implementation & ongoing support.
  • Software Testing (Manual Testing).


Verification Expert

Jumio India Pvt. Ltd.
03.2017 - 08.2021
  • Documentation verification as per PII guidelines
  • Analyze Manipulation in documents to prevent online fraud
  • Analyze and troubleshoot problems experienced by Jumio Customers
  • Analyzing data to identify anomalies or patterns that may indicate fraudulent activity

Education

M.com -

Mohanlal Sukhadia University
Udaipur, India
01.2017 - 08.2021

B.com -

Mohanlal Sukhadia University
Udaipur, India
01.2014 - 01.2016

Skills

Good Understanding of GxP, 21 CFR Part 11, GAMP 5

Certification

Software Development Processes and Methodologies, University of Minnesota, 01/2022

Interests

E-Sports
Books Reading
Travelling
Listening music

Timeline

Consultant - Business Technology

Sarjen Systems Pvt Ltd.
01.2022 - 03.2025

Verification Expert

Jumio India Pvt. Ltd.
03.2017 - 08.2021

M.com -

Mohanlal Sukhadia University
01.2017 - 08.2021

B.com -

Mohanlal Sukhadia University
01.2014 - 01.2016
Shubham JainConsultant - Business Technology