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
CSV Validation (PMP, VT, VP, URS, FS, RA/IA, RSA, IQ, OQ, PQ, TM and VSR)
Good Understanding of SDLC Process, CAPA and Deviation Management
Quality Assurance - QMS, Change Control
Manual Software Testing - Test Plan, Test Script, Test Cases
SaaS (Software as a Service) for Clinical Trials
Soft Skills - Adaptable, Quick Learner, Work Oriented
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