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职场能力评价定义
簡孝誠(Siao-Cheng Jian)
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]
Experience
創源生技 GGA Corp.
Project Manager
Apr 2022 ~ present
Provide total solution to customers for the needs of electronic management system and to comply regulatory requirements.
- Manage projects of electronic management system conduction, and coordinate internal/external resource.
- Lead clients to establish validation documents complied requirements of GAMP5, 21 CFR Part 11 and PIC/S GMP.
- Perform consultation service for software validation.
- Provide operation training of electronic systems to clients.
- Support sales team to perform presale activity.
啓弘生技 TFBS Bioscience
QA Scientist
Nov 2021 ~ Mar 2022
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
- Establish and revise SOP of QMS to comply requirements of regulatory authority, the third-party and clinets.
- Plan and perform internal audit and track the improvement actions.
- Coordinate the execution of external audit.
- Perform the investigation of deviation.
- Perform the impact analysis of change control and track the effectiveness of change.
- Lead the CAPA planing and track the completion and effectiveness of CAPA.
- Perform the annual review of deviation, change control and CAPA.
- Review the manufacturing plan and the product batch record.
行動基因生技 ACT Genomics
Associate QA Director
Dec 2014 ~ Aug 2021
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
台灣東洋藥品 TTY Biopharm
Scientist
May 2009 ~ Nov 2014
(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
賽亞基因科技 Vita genomics
Assistant Scientist
Sep 2007 ~ Apr 2009
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
中央研究院 Academia Sinica
Research assistant
Oct 2006 ~ Aug 2007
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
Experience
啓弘生技 TFBS Bioscience
QA Scientist
Nov 2021 ~ present
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
- Establish and revise SOP of QMS to comply requirements of regulatory authority, the third-party and clinets.
- Plan and perform internal audit and track the improvement actions.
- Coordinate the execution of external audit.
- Perform the investigation of deviation.
- Perform the impact analysis of change control and track the effectiveness of change.
- Lead the CAPA planing and track the completion and effectiveness of CAPA.
- Perform the annual review of deviation, change control and CAPA.
- Review the manufacturing plan and the product batch record.
行動基因生技 ACT Genomics
Associate QA Director
Dec 2014 ~ Aug 2021
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
台灣東洋藥品 TTY Biopharm
Scientist
May 2009 ~ Nov 2014
(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
賽亞基因科技 Vita genomics
Assistant Scientist
Sep 2007 ~ Apr 2009
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
中央研究院 Academia Sinica
Research assistant
Oct 2006 ~ Aug 2007
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
學歷
CHUNG SAN MEDICAL UNIVERSITY, M.S. in Medical and Molecular Toxicology, 2001 ~ 2003
TUNGHAI UNIVERSITY, B.S. in Food Science, 1996 ~ 2000
簡孝誠(Siao-Cheng Jian)
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]
Experience
創源生技 GGA Corp.
Project Manager
Apr 2022 ~ present
Provide total solution to customers for the needs of electronic management system and to comply regulatory requirements.
- Manage projects of electronic management system conduction, and coordinate internal/external resource.
- Lead clients to establish validation documents complied requirements of GAMP5, 21 CFR Part 11 and PIC/S GMP.
- Perform consultation service for software validation.
- Provide operation training of electronic systems to clients.
- Support sales team to perform presale activity.
啓弘生技 TFBS Bioscience
QA Scientist
Nov 2021 ~ Mar 2022
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
- Establish and revise SOP of QMS to comply requirements of regulatory authority, the third-party and clinets.
- Plan and perform internal audit and track the improvement actions.
- Coordinate the execution of external audit.
- Perform the investigation of deviation.
- Perform the impact analysis of change control and track the effectiveness of change.
- Lead the CAPA planing and track the completion and effectiveness of CAPA.
- Perform the annual review of deviation, change control and CAPA.
- Review the manufacturing plan and the product batch record.
行動基因生技 ACT Genomics
Associate QA Director
Dec 2014 ~ Aug 2021
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
台灣東洋藥品 TTY Biopharm
Scientist
May 2009 ~ Nov 2014
(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
賽亞基因科技 Vita genomics
Assistant Scientist
Sep 2007 ~ Apr 2009
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
中央研究院 Academia Sinica
Research assistant
Oct 2006 ~ Aug 2007
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management
Experience
啓弘生技 TFBS Bioscience
QA Scientist
Nov 2021 ~ present
Maintain and establish QMS of virus vetor manufacturing facility to comply PIC/S GMP requirements and client requirements.
- Establish and revise SOP of QMS to comply requirements of regulatory authority, the third-party and clinets.
- Plan and perform internal audit and track the improvement actions.
- Coordinate the execution of external audit.
- Perform the investigation of deviation.
- Perform the impact analysis of change control and track the effectiveness of change.
- Lead the CAPA planing and track the completion and effectiveness of CAPA.
- Perform the annual review of deviation, change control and CAPA.
- Review the manufacturing plan and the product batch record.
行動基因生技 ACT Genomics
Associate QA Director
Dec 2014 ~ Aug 2021
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
台灣東洋藥品 TTY Biopharm
Scientist
May 2009 ~ Nov 2014
(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
賽亞基因科技 Vita genomics
Assistant Scientist
Sep 2007 ~ Apr 2009
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
中央研究院 Academia Sinica
Research assistant
Oct 2006 ~ Aug 2007
1. Produce recombinant plant proteins and analyze the dimer binding activity
2. Lab management