Summary
Overview
Work History
Education
Timeline
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Tiantian Cui

QA Specialist
Shanghai, China

Summary

Quality Assurance professional with hands-on experience in GMP-regulated environments. Key strengths include Computerized System Validation (CSV), quality documentation, and basic knowledge of statistics. Familiar with regulatory standards such as GAMP5, ICH guidelines, and 21 CFR Part 11. Strong team communication, careful and patient in quality-related work.

Overview

5
5
years of professional experience
2
2
Languages

Work History

QA Specialist

Shanghai United Imaging MetaHealthcare Co., Ltd.
04.2024 - 07.2024
  • Independently completed the validation of a DMS used in the QMS, including planning, risk assessment, testing, and documentation in compliance with 21 CFR Part 11.
  • Contributed to the development of a software quality plan and coordinated with R&D to complete key lifecycle activities, ensuring compliant and auditable development processes.

QA Specialist

Shanghai Shell BioTech Co., Ltd
03.2022 - 08.2023
  • Independently drafted and revised various quality system procedures, including data integrity guidelines, validation management procedures, and computerized system control SOPs.
  • Reviewed QC data records and collaborated with the QC team on deviation investigations, CAPA planning, and change control within the GMP scope.
  • Participated in the validation of electronic spreadsheets with IT support; performed compliance checks on access control, audit trails, and data integrity.

Validation Specialist

Shanghai QILY Biotechnology Co., Ltd.
03.2019 - 03.2022
  • Participated in validation of the Laboratory Information Management System (LIMS), executing IQ/OQ/PQ protocols and preparing validation reports to ensure proper documentation structure.
  • Performed periodic backup and recovery validations of electronic data, including environment configuration, data extraction, and data comparison.
  • Drafted validation protocols for temperature mapping in accordance with GMP requirements and be familiar with the use of various validation instruments (Vaisala, testo, Kaye).

Education

Bachelor of Science - Environmental Science

Minzu University of China
Beijing, China
04.2001 -

Timeline

QA Specialist

Shanghai United Imaging MetaHealthcare Co., Ltd.
04.2024 - 07.2024

QA Specialist

Shanghai Shell BioTech Co., Ltd
03.2022 - 08.2023

Validation Specialist

Shanghai QILY Biotechnology Co., Ltd.
03.2019 - 03.2022

Bachelor of Science - Environmental Science

Minzu University of China
04.2001 -

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