Word
Tseng, Hsiao-Chun (Cindy)
No. 60 Naning Street
Summary
Multi-tasking Manager well-known for creating positive workplace culture and high-performing teams. Willingness to take on added responsibilities to meet team goals.
Overview
17
17
years of professional experience
2
2
Certifications
2
2
Languages
Work History
Quality Manager
Hyper Quantum Technologies, Ltd.
08.2021 - Current
- Coordinated and oversaw periodic inspection from TAF/ TFDA/ NIEA to meet ISO17025 and address non-conformances.
- Launched quality assurance practices to ensure data result.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Excellent communication skills, both internal and external.
- Learned and adapted quickly to new technology and software applications.
Quality Assurance Supervisor
ScinoPharm Taiwan, Ltd.
12.2019 - 06.2021
- Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance member.
- Boosted customer satisfaction by promptly addressing concerns, investigating root causes, and implementing corrective actions.
- Determined quality department standards, practices, and procedures..
- Established and tracked quality department goals and objectives.
- Approved risk assessments for proposed changes in processes or materials to evaluate potential impact on product quality and ensure smooth implementation.
- Maintained comprehensive documentation of QA activities, supporting effective communication between departments and facilitating process improvements.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Recorded, analyzed, and distributed statistical information.
- Addressed non-conformance issues, pausing production to correct errors.
- Achieved consistent compliance with GMP regulations by conducting thorough internal audits and ensuring adherence to standards.
- Analyzed data from quality metrics to identify trends and opportunities for improvement, driving targeted action plans based on findings on quality review meeting.
- Collaborated with customer audit and authority inspection (US-FDA/ EU-EMA/ JP-PMDA/ TW-TFDA) to get product GMP certificate.
Quality Assurance Specialist
ScinoPharm Taiwan, Ltd.
04.2013 - 12.2019
- Conducted investigations into questionable test results (Karl Fischer(KF)、Loss on Drying(LOD)、Dierential Scanning Calorimetry (DSC)、Specic Rotation (SR)、Ultraviolet/Visible Spectrophotometry(UV)、Iron Chromatorgraphy (IC)、HPLC 、 Gas Chromatography(GC) 、 Liquid Chromatography(LC) 、 Inductively Coupled Plasma-Opticl Emission Spectroscopy (ICP-OES)).
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments, R&D, Operation and QC.
- Utilized root cause analysis techniques to identify underlying issues contributing to non-conformance or customer complaints.
- Addressed non-conformance issues, pausing production to correct errors.
- Reviewed production processes and identified potential quality issues.
- Streamlined the documentation process, ensuring adherence to GMP requirements.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
Regulatory Affire and Customer Technical Servive
ScinoPharm Taiwan Ltd.
12.2008 - 04.2013
- Collaborated with customer for Drug Mater File (DMF) registration to all over the world include US/FDA, EU/EMA, Swiss/Swissmedic, German/BfArM, Japan/PMDA, Taiwan/TFDA and Chinese/SFDA.
- Resolved technical issues for customers prom.
- Responded promptly for technical inquiry.
- Developed strong relationships with customers by consistently exceeding expectations in problem-solving capabilities.
- Collaborated with cross-functional departments to address recurring customer issues and implement long-term solutions.
QC Chemist
Waste Management, Inc.
09.2007 - 08.2008
- Tested landfill gas by using Gas Chromatography-FID (GC-FID) to analyze composition.
- Collaborated with engineers improve the process efficiency.
- Troubleshot issues with analytical equipment, quickly identifying root causes and implementing effective solutions.
- Developed new testing methods for emerging compounds, ensuring accurate identification and quantification of analyses.
- Identified issues, analyzed information and provided solutions to problems.
- Worked flexible hours across night, weekend, and holiday shifts.
Education
Master of Liberal Arts - Leadership
Oklahoma City University
Okalahoma City, USA 04.2001 -
Master of Science - Analytical Chemistry
National Chun Kung University
Tainan City, Taiwan 04.2001 -
Bachelor of Science - Chemistry
National Chun Kung University
Tainan City, Taiwan 04.2001 -
Skills
Documentation Control
Internal Auditing
Positive Attitude
Quality Management Systems
Certification
PMP Certicate
Awards Activities
- Arts & Sciences Graduate Scholarship
- Vice-Presiden of OCU Taiwanese Student Association
Software
Excel
Power Point
Visio
Chem Draw
Timeline
Quality Manager
Hyper Quantum Technologies, Ltd.
08.2021 - Current
Quality Assurance Supervisor
ScinoPharm Taiwan, Ltd.
12.2019 - 06.2021
Quality Assurance Specialist
ScinoPharm Taiwan, Ltd.
04.2013 - 12.2019
Regulatory Affire and Customer Technical Servive
ScinoPharm Taiwan Ltd.
12.2008 - 04.2013
QC Chemist
Waste Management, Inc.
09.2007 - 08.2008
Master of Liberal Arts - Leadership
Oklahoma City University
04.2001 -
Master of Science - Analytical Chemistry
National Chun Kung University
04.2001 -
Bachelor of Science - Chemistry
National Chun Kung University
04.2001 -