Li Ying Kimberly Tan
Summary
Quality Assurance (QA) Specialist with 5 years of experience and strong background in quality processes, operational oversight and cross functional coordination within fast-paced environments. Skilled in problem solving, strong communicator and collaborator with focus on process improvement and efficiency and ensures compliance with internal standards and regulatory requirements.
Overview
7
7
years of professional experience
Work History
Quality Assurance (QA) Specialist
Pfizer Asia Manufacturing Pte Ltd
09.2021 - Current
- Collaborated with cross functional team to successfully startup a new facility and oversee product technology transfer processes.
- Provided comprehensive QA oversight for manufacturing startups, cleaning operations, production areas and various quality systems such as SAP and gLIMS.
- Responsible for review and approval of procedures, master batch records, deviations and change controls to ensure compliance and production integrity.
- Disposition of Intermediates and Active Pharmaceutical Ingredients (API) to fulfill shipment requirements.
- Played critical role in supporting internal and external audits and acted as subject matter expert (SME) for batch disposition processes.
- Coordinate with cross functional team to compile and prepare annual product record review (APRR) report.
- Offered guidance and mentorship to members within the QA team.
Quality Assurance Specialist
Pfizer Asia Pacific Pte Ltd
03.2020 - 09.2021
- Trained in current Good Manufacturing Process (cGMP)
- Responsible for review of GMP documents such as manufacturing batch records, laboratory records, equipment cleaning records and etc in ensuring compliance with regulatory standards.
- Disposition of Intermediates and Active Pharmaceutical Ingredients (API) to fulfill shipment requirements.
- Worked with various cross functional team to improve the quality system and meeting shipment needs
- Provided QA oversight by conducting weekly GMP walkdown and manufacturing startup supports
Risk and Modelling Intern
BMT Singapore Pte Ltd
07.2018 - 01.2019
- Conducted Quantitative Risk Assessment (QRA) studies for chemical plants
- Assisted in the predictive and emergency response aspects of Safety Case development
- Trained in various Process Hazards Analysis Software such as DNV PHAST, TNO Riskcurves, QGIS and BowTieXP
Education
BEng (Hons) - Chemical Engineering
SIT-Newcastle University
09.2019
Skills
- Proficient in Microsoft Excel, PowerPoint, and Word
- Familiar with programming applications such as Excel Visual Basic Application (VBA) Macro, MATLAB and Honeywell UniSim Simulation
- Trained in various software used in the manufacturing plant such as SAP, Veeva Vault, QTS Track wise, gLIMS, rockwell software (AMPS), etc
- Experience with industrial risk analysis tools (DNV PHAST, QGIS, BowTieXP)
- Six Sigma (Yellow belt certified)
- Fluent in both spoken and written English and Chinese
Timeline
Quality Assurance (QA) Specialist
Pfizer Asia Manufacturing Pte Ltd
09.2021 - Current
Quality Assurance Specialist
Pfizer Asia Pacific Pte Ltd
03.2020 - 09.2021
Risk and Modelling Intern
BMT Singapore Pte Ltd
07.2018 - 01.2019
BEng (Hons) - Chemical Engineering
SIT-Newcastle University
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