Soniya Pun
CSV Engineer at PSC Biotech Corporation. Veeva Vault White Belt Certified.
- Role
- Csv Engineer at PSC Biotech® Corporation
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Soniya Pun
Computer System Validation Engineer with 5 years of experience in Pharmaceutical and…
Experience
Csv Engineer
Mar 2021 — Present
Authors, edits and reviews validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).• Perform executions of Validation, Qualification, Re-Qualification protocols and Hot Fixes for Computer Systems.• Reviews and creates Validation deliverables like Test plans, Test scripts, and Test incidents (TIs) or Deviations.• Assists in reviewing and updating Validation documents such as Validation Plans, Requirement Documents, Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).• Maintains Knowledge of the field i.e. GAMP 5, cGXPs (cGMP, cGLP, cGDP) and 21 CFR part 11.• Keep informed with advances of the system application to ensure system is in compliant with GxP regulations.• Team player with excellent analytical, presentation, communication, and technical writing skills.
Education
Baruch College
Bachelor's degree, Business Administration and Management, General
2020
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