Amarjeet Samal
Quality Specialist at Xellia Pharmaceuticals || Ex- Accenture || ITQA || CSV || GAMP || Validation || GxP || Regulatory Compliance
- Role
- Quality Specialist at Xellia Pharmaceuticals
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Amarjeet Samal
3+ years of experience in CSV(Computer system validation) with two European pharma clients. Knowledge on validating GxP and Non- GxP software in the pharmaceutical industry. Following the SOP\'s and guidelines as per regulatory and compliance and maintaining the application should meet the quality standards. Preparing Validation plan and reports, reviewing and approving of requirements, IQ\'s, OQ\'s, PQ\'s, test runs. Performing risk assessment and traceability matrix. Rasing defect and CAPA handling. Knowledge on FDA, 21 CFR Part 11, EU Annexure 11, ALCOA principles, IT Change management.Supported as a Validation tester for Veeva Vault. performed Integration testing, Ensuring correct data is being populated in the veeva system through integration systems.
Experience
Quality Specialist
Nov 2025 — Present · Bengaluru, IN
Education
Regional College of Management (RCM), Bhubaneswar
Bachelor of Business Administration - BBA, Marketing
2018 — 2021
Manipal University Jaipur
Master of Business Administration - MBA, Information Technology
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