Sing Sing Ting
QA Team Leader
Tainan City,TNN
Summary
Dynamic QA Team Leader with a proven track record at ScinoPharm Taiwan, Ltd., excelling in team supervision and analytical thinking. Spearheaded initiatives that significantly increased customer satisfaction and streamlined workflows. Demonstrated exceptional leadership and collaboration skills, mentoring staff and fostering a culture of continuous improvement.
Overview
11
11
years of professional experience
1
1
Certification
Work History
QA Team Leader
ScinoPharm Taiwan, Ltd.
07.2024 - Current
- Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
- Mentored junior staff members, helping them develop their leadership potential and advance in their careers.
- Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Collaborated with other department leaders to establish shared goals and ensure alignment across teams.
- Increased customer satisfaction ratings by closely monitoring service quality standards and addressing any issues promptly.
- Streamlined workflows for increased efficiency, reducing turnaround times for critical tasks.
- Facilitated culture of continuous improvement, encouraging feedback and innovative solutions from all team members.
- Increased customer satisfaction with prompt and accurate issue resolution, leading dedicated customer service team.
QA Specialist
ScinoPharm Taiwan, Ltd.
07.2016 - 06.2024
- Project coordinator for responsible products: review and approved the executed and relevant document (BPR, cleaning, process set-up, stability etc).
- Review and approve change proposals to ensure changes affecting processes, starting material, packaging material, testing methods and qualification fundamentals are technically feasible and adequately supported.
- Reviewing process or cleaning validation protocols/ reports/results and support batch execution.
- Conduct non-conformance, customer complaint investigation for root cause analysis and customer notification.
- Review final testing results and preparation for product release and product shipment.
- Handling internal/external GMP inspection includes Taiwan FDA inspection, US FDA inspection, EDQM inspection, PMDA inspection and etc.
- Handling audit, questionnaires from customers and desktop audit from regulatory.
- On-site audit and Remote audit for supplier in China, India, Germany and France for vendor qualification.
- Perform internal audit.
- Coordinate and perform GMP training.
Compliance Specialist
ScinoPharm Taiwan, Ltd.
11.2015 - 06.2016
- Initiate and review the GMP related documents: SOP and Work instruction.
- Handling audit and questionnaires from the regulatory agencies and customers.
- Vendor qualifications (include conducting on-site audit)
- Handling and coordinate for annual product review.
- Coordinate GMP training for new employees and all employees.
- Monitor the site cGMP practices.
Injectable Quality Control ASO Microbiologist
ScinoPharm Taiwan, Ltd.
10.2014 - 10.2015
- Issue and conduct equipment qualification documentation (IQ, OQ, PQ) for newly installed equipment: Oven, particle counter, refrigerator.
- Conduct qualification or validation for new analytical testing method.
- Drafting and issue standard operation procedure.
- Purchase for laboratory supplies and contact window for equipment calibration.
Quality Control ASO Microbiologist
ScinoPharm Taiwan, Ltd.
07.2013 - 09.2014
- Conduct microbiology and endotoxin testing for Active Pharmaceutical Ingredient (API) product.
- Monitoring for the Utility and HVAC system: process purified water, softened potable water and environment testing for control area.
- Medium preparation, growth promotion testing and perform other daily activities.
- Conduct qualification or validation for new analytical testing method.
- Support failure investigations include out of specification investigation in utility system and product, assistance for root cause identification.
Education
Master of Environmental And Occupational Health - Environmental Toxicology And Chemical Analysis
National Cheng Kung University
Tainan 04.2001 -
Bachelor - Nursing
National Cheng Kung University
Tainan 04.2001 -
Skills
Team Supervision
Languages
Chinese (Mandarin)
Native language
English
Upper intermediate
B2
Malay
Upper intermediate
B2
Chinese (Cantonese)
Intermediate
B1
Certification
IRCA Certified ISO 9001:2015 Lead Auditor Training Course (Certificate Number: ENR-00313726)
Audit Experiences: Customer, Regulatory agency, Manufacturer
Organize & participant in customer audit number:
Year 2015: 5
Year 2016: 17
Year 2017: 22
Year 2018: 11
Year 2019: 15
Year 2020: 14
Year 2021: 6
Year 2022: 7
Year 2023: 12
Year 2024: 16
Organize & participant in Regulatory agency inspection number:
Year 2016: Taiwan FDA-3, EDQM-1, German local authority: Hessen-1, Mexico COFEPRIS-1
Year 2017: Taiwan FDA-2, US FDA-1, Mexico COFEPRIS-1, PMDA-1
Year 2018: Taiwan FDA-1, Mexico COFEPRIS-1, Russian Federation-1
Year 2019: Taiwan FDA-1, US FDA-1
Year 2020: Taiwan FDA-1
Year 2021: Taiwan FDA-2
Year 2022: US FDA-2, Taiwan FDA-1
Year 2023: Taiwan FDA-1
Year 2024: Taiwan FDA-1, US FDA-1, ANVISA-1 (expected in Nov. 2024)
Starting Material Manufacturer audit number:
Year 2016-China-3
Year 2017: India-3, Taiwan-1
Year 2018: Taiwan-1, China-4
Year 2019: France-1, China-11, India-2, Belgium-1, Germany-1
Year 2020: Taiwan-1
Year 2021 (Remote): India-2, US-1, China-2
Year 2022 (Remote): India-2, China-5
Year 2023: Remote: China-3, India-1, On-site: China-4
Year 2024: Remote: US-1, On-site: China-6, Taiwan-1
Timeline
QA Team Leader
ScinoPharm Taiwan, Ltd.
07.2024 - Current
IRCA Certified ISO 9001:2015 Lead Auditor Training Course (Certificate Number: ENR-00313726)
09-2017
QA Specialist
ScinoPharm Taiwan, Ltd.
07.2016 - 06.2024
Compliance Specialist
ScinoPharm Taiwan, Ltd.
11.2015 - 06.2016
Injectable Quality Control ASO Microbiologist
ScinoPharm Taiwan, Ltd.
10.2014 - 10.2015
Quality Control ASO Microbiologist
ScinoPharm Taiwan, Ltd.
07.2013 - 09.2014
Master of Environmental And Occupational Health - Environmental Toxicology And Chemical Analysis
National Cheng Kung University
04.2001 -
Bachelor - Nursing
National Cheng Kung University
04.2001 -
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