I have nearly 7 years of experience in leading QA team to conduct and maintain quality management system, and handling audits of the third-party, clients and the regulatory authority. During my tenure of QA Head, I successfully completed 4 laboratory accreditations and 1 ISMS certiêcation. Prior to QAH, I had more than 5 years of experience in research and development of new drug.
New Taipei City,TW
+8860909040984
[email protected]
Provide total solution to customers for the needs of electronic management system and to comply regulatory requirements.
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
Lead the QA Department to establish and maintain QMS of NGS laboratory to comply requirements of regulatory authority, the thrid-party and clients.
(1.) Lead and coordinate conduction and maintenance of quality management system.
(2.) Perform internal audits.
(3.) Perform external audits from regulatory authority, the thrid-party and clients.
(4.) Perform client audits to meet client’s requirements (GCP-like and CLP).
(5.) Follow-up the handling of deveiaitons and confirm implementation of CAPA
(6.) Review validation plan and report of test method.
(7.) Control QMS documentation system of procedure, SOP and records.
(8.) Lead QMS conductions for overseas
laboratories (Japanese and Hongkong) and
partner’s laboratory (China).
[Experience of accreditaiton and certification:]
1. ISO17025
(1.) Initial accreditaiton:Dec. 2014 - Jul. 2015
2. ISO15189 (ACTPrecision Medical Laboratory)
(1.) Initial accreditation:Jan. 2017 - Apr. 2018
3. CAP (College of American Pathologists)
(1.) Initial accreditaiton:Jan. 2015 - Apr. 2016
4. CLIA (Clinical Laboratory Improvement Amendment of 1988)
(1.) Applicaiton and review:Jul. 2018 - Dec. 2019
(2.) On-site inspection:pending due to COVID-19 pandemics
5. TFDA LDTS (精準醫療分子檢測實驗室檢測與服務指引)
(1.) Initial accreditaiton:Apr. 2019 - May. 2020
6. ISO27001
(1.) Initial certification:Dec. 2019 - Sep. 2020
7. ISO13485 + QSR (21 CFR 820)
(1.) Initial certification:Jul. 2020 - Dec. 2021
(I.) Maintain ISO17025 certification
1. Responsible for the Technical Supervisor of Molecular Testing
(II.) Design and implement experiments for proof of concept(POC) of new drug.
1. Conduct and validate the analysis method for POC.
2. Plan and implement experiments to study new drugs.
3. Develop testing methods for biomarker analysis.
4. Generate evaluation reports of new drug candidates.
[Experience of projects:]
1. Liposomal nucleic acid drug (2011 – 2014)
- MOA confirmation and Potency assay development
- Design and manage PD study in tumor model
- Execute PK method development and in-house PK study
- Biomarker development by real-time PCR system (TaqMan, SYBR Green)
2. A recombinant protein drug (2010 – 2012)
- Proof MOA and quality in cancer cell model
- Organize in vivo study to evaluate efficacy
4. A chemical compound to decrease oxidative stress (2011)
- Organize a team to evaluate the prevention of Hand-Foot syndrome induced by Doxorubicin in rat model
5. Pharmacogenetic biomarker development (2009)
- Develop gene mutation analysis in FFPE tissue or whole blood
1. Develop genotyping plat form and execute biomarker project
2. Optimize assay protocol for cost down and increasing efficiency
3. Support sales and market team for technique introduction
1. Develop and execute gene mutation system for Family
Hypercholesterolemia by using Affymetrix platform and MLPA system.
2. Develop gene array for BRCA1/2 mutation detection in
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
Lead the QA Department to establish and maintain QMS of NGS laboratory to comply requirements of regulatory authority, the thrid-party and clients.
(1.) Lead and coordinate conduction and maintenance of quality management system.
(2.) Perform internal audits.
(3.) Perform external audits from regulatory authority, the thrid-party and clients.
(4.) Perform client audits to meet client’s requirements (GCP-like and CLP).
(5.) Follow-up the handling of deveiaitons and confirm implementation of CAPA
(6.) Review validation plan and report of test method.
(7.) Control QMS documentation system of procedure, SOP and records.
(8.) Lead QMS conductions for overseas
laboratories (Japanese and Hongkong) and
partner’s laboratory (China).
[Experience of accreditaiton and certification:]
1. ISO17025
(1.) Initial accreditaiton:Dec. 2014 - Jul. 2015
2. ISO15189 (ACTPrecision Medical Laboratory)
(1.) Initial accreditation:Jan. 2017 - Apr. 2018
3. CAP (College of American Pathologists)
(1.) Initial accreditaiton:Jan. 2015 - Apr. 2016
4. CLIA (Clinical Laboratory Improvement Amendment of 1988)
(1.) Applicaiton and review:Jul. 2018 - Dec. 2019
(2.) On-site inspection:pending due to COVID-19 pandemics
5. TFDA LDTS (精準醫療分子檢測實驗室檢測與服務指引)
(1.) Initial accreditaiton:Apr. 2019 - May. 2020
6. ISO27001
(1.) Initial certification:Dec. 2019 - Sep. 2020
7. ISO13485 + QSR (21 CFR 820)
(1.) Initial certification:Jul. 2020 - Dec. 2021
(I.) Maintain ISO17025 certification
1. Responsible for the Technical Supervisor of Molecular Testing
(II.) Design and implement experiments for proof of concept(POC) of new drug.
1. Conduct and validate the analysis method for POC.
2. Plan and implement experiments to study new drugs.
3. Develop testing methods for biomarker analysis.
4. Generate evaluation reports of new drug candidates.
[Experience of projects:]
1. Liposomal nucleic acid drug (2011 – 2014)
- MOA confirmation and Potency assay development
- Design and manage PD study in tumor model
- Execute PK method development and in-house PK study
- Biomarker development by real-time PCR system (TaqMan, SYBR Green)
2. A recombinant protein drug (2010 – 2012)
- Proof MOA and quality in cancer cell model
- Organize in vivo study to evaluate efficacy
4. A chemical compound to decrease oxidative stress (2011)
- Organize a team to evaluate the prevention of Hand-Foot syndrome induced by Doxorubicin in rat model
5. Pharmacogenetic biomarker development (2009)
- Develop gene mutation analysis in FFPE tissue or whole blood
1. Develop genotyping plat form and execute biomarker project
2. Optimize assay protocol for cost down and increasing efficiency
3. Support sales and market team for technique introduction
1. Develop and execute gene mutation system for Family
Hypercholesterolemia by using Affymetrix platform and MLPA system.
2. Develop gene array for BRCA1/2 mutation detection in
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
I have nearly 7 years of experience in leading QA team to conduct and maintain quality management system, and handling audits of the third-party, clients and the regulatory authority. During my tenure of QA Head, I successfully completed 4 laboratory accreditations and 1 ISMS certiêcation. Prior to QAH, I had more than 5 years of experience in research and development of new drug.
New Taipei City,TW
+8860909040984
[email protected]
Provide total solution to customers for the needs of electronic management system and to comply regulatory requirements.
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
Lead the QA Department to establish and maintain QMS of NGS laboratory to comply requirements of regulatory authority, the thrid-party and clients.
(1.) Lead and coordinate conduction and maintenance of quality management system.
(2.) Perform internal audits.
(3.) Perform external audits from regulatory authority, the thrid-party and clients.
(4.) Perform client audits to meet client’s requirements (GCP-like and CLP).
(5.) Follow-up the handling of deveiaitons and confirm implementation of CAPA
(6.) Review validation plan and report of test method.
(7.) Control QMS documentation system of procedure, SOP and records.
(8.) Lead QMS conductions for overseas
laboratories (Japanese and Hongkong) and
partner’s laboratory (China).
[Experience of accreditaiton and certification:]
1. ISO17025
(1.) Initial accreditaiton:Dec. 2014 - Jul. 2015
2. ISO15189 (ACTPrecision Medical Laboratory)
(1.) Initial accreditation:Jan. 2017 - Apr. 2018
3. CAP (College of American Pathologists)
(1.) Initial accreditaiton:Jan. 2015 - Apr. 2016
4. CLIA (Clinical Laboratory Improvement Amendment of 1988)
(1.) Applicaiton and review:Jul. 2018 - Dec. 2019
(2.) On-site inspection:pending due to COVID-19 pandemics
5. TFDA LDTS (精準醫療分子檢測實驗室檢測與服務指引)
(1.) Initial accreditaiton:Apr. 2019 - May. 2020
6. ISO27001
(1.) Initial certification:Dec. 2019 - Sep. 2020
7. ISO13485 + QSR (21 CFR 820)
(1.) Initial certification:Jul. 2020 - Dec. 2021
(I.) Maintain ISO17025 certification
1. Responsible for the Technical Supervisor of Molecular Testing
(II.) Design and implement experiments for proof of concept(POC) of new drug.
1. Conduct and validate the analysis method for POC.
2. Plan and implement experiments to study new drugs.
3. Develop testing methods for biomarker analysis.
4. Generate evaluation reports of new drug candidates.
[Experience of projects:]
1. Liposomal nucleic acid drug (2011 – 2014)
- MOA confirmation and Potency assay development
- Design and manage PD study in tumor model
- Execute PK method development and in-house PK study
- Biomarker development by real-time PCR system (TaqMan, SYBR Green)
2. A recombinant protein drug (2010 – 2012)
- Proof MOA and quality in cancer cell model
- Organize in vivo study to evaluate efficacy
4. A chemical compound to decrease oxidative stress (2011)
- Organize a team to evaluate the prevention of Hand-Foot syndrome induced by Doxorubicin in rat model
5. Pharmacogenetic biomarker development (2009)
- Develop gene mutation analysis in FFPE tissue or whole blood
1. Develop genotyping plat form and execute biomarker project
2. Optimize assay protocol for cost down and increasing efficiency
3. Support sales and market team for technique introduction
1. Develop and execute gene mutation system for Family
Hypercholesterolemia by using Affymetrix platform and MLPA system.
2. Develop gene array for BRCA1/2 mutation detection in
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
Lead the QA Department to establish and maintain QMS of NGS laboratory to comply requirements of regulatory authority, the thrid-party and clients.
(1.) Lead and coordinate conduction and maintenance of quality management system.
(2.) Perform internal audits.
(3.) Perform external audits from regulatory authority, the thrid-party and clients.
(4.) Perform client audits to meet client’s requirements (GCP-like and CLP).
(5.) Follow-up the handling of deveiaitons and confirm implementation of CAPA
(6.) Review validation plan and report of test method.
(7.) Control QMS documentation system of procedure, SOP and records.
(8.) Lead QMS conductions for overseas
laboratories (Japanese and Hongkong) and
partner’s laboratory (China).
[Experience of accreditaiton and certification:]
1. ISO17025
(1.) Initial accreditaiton:Dec. 2014 - Jul. 2015
2. ISO15189 (ACTPrecision Medical Laboratory)
(1.) Initial accreditation:Jan. 2017 - Apr. 2018
3. CAP (College of American Pathologists)
(1.) Initial accreditaiton:Jan. 2015 - Apr. 2016
4. CLIA (Clinical Laboratory Improvement Amendment of 1988)
(1.) Applicaiton and review:Jul. 2018 - Dec. 2019
(2.) On-site inspection:pending due to COVID-19 pandemics
5. TFDA LDTS (精準醫療分子檢測實驗室檢測與服務指引)
(1.) Initial accreditaiton:Apr. 2019 - May. 2020
6. ISO27001
(1.) Initial certification:Dec. 2019 - Sep. 2020
7. ISO13485 + QSR (21 CFR 820)
(1.) Initial certification:Jul. 2020 - Dec. 2021
(I.) Maintain ISO17025 certification
1. Responsible for the Technical Supervisor of Molecular Testing
(II.) Design and implement experiments for proof of concept(POC) of new drug.
1. Conduct and validate the analysis method for POC.
2. Plan and implement experiments to study new drugs.
3. Develop testing methods for biomarker analysis.
4. Generate evaluation reports of new drug candidates.
[Experience of projects:]
1. Liposomal nucleic acid drug (2011 – 2014)
- MOA confirmation and Potency assay development
- Design and manage PD study in tumor model
- Execute PK method development and in-house PK study
- Biomarker development by real-time PCR system (TaqMan, SYBR Green)
2. A recombinant protein drug (2010 – 2012)
- Proof MOA and quality in cancer cell model
- Organize in vivo study to evaluate efficacy
4. A chemical compound to decrease oxidative stress (2011)
- Organize a team to evaluate the prevention of Hand-Foot syndrome induced by Doxorubicin in rat model
5. Pharmacogenetic biomarker development (2009)
- Develop gene mutation analysis in FFPE tissue or whole blood
1. Develop genotyping plat form and execute biomarker project
2. Optimize assay protocol for cost down and increasing efficiency
3. Support sales and market team for technique introduction
1. Develop and execute gene mutation system for Family
Hypercholesterolemia by using Affymetrix platform and MLPA system.
2. Develop gene array for BRCA1/2 mutation detection in
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management