Patrick Yu Email & Phone Number

Taiwan

台灣 臺北市 內湖區

台灣 臺北市 內湖區

Responsible for ensuring that ACT Genomics products and services meet the established standards set by the company. This includes the implementation, maintenance and continuous improvement of Quality Management System and ensure all activities are conducted in compliance with the Quality Management System and regulation requirements.Key Responsibility:1. Responsible for maintaining and implementing the Quality Management System such as Production and Process Control , Design Controls, Risk Management, Nonconformity Management, Corrective and Preventative Action (CAPA), Complaint Handling, Supplier Qualification and Management.2. Strategic planning and harmonization of the quality system across different certification such as ISO13485, CAP accreditation, LDTS certification, and ISO 27001 & ISO 27701.3. Effectively collaborate cross-functionally to facilitate the continuous improvement of Quality Management System.4. Conduct RCA (root cause analysis) and correction, CAPA (corrective and preventative actions) and effectiveness check of quality event such as nonconformity, deviation or audit finding.5. Host the management review and responsible for developing, measuring, and monitoring quality indicators in the Quality Management Review.6. Develop and maintain the audit program of internal and external audit activities including ISO 13485, CAP accreditation , LDTS certification, ISO 27001 & ISO 27701 and customer audit.7. Submission of new service application and maintain the LDTS certification of company product.8. Responsible for maintaining and implementing the Management System of information security and data privacy. Ensure the function of Data Protection Office.

台灣 桃園市 桃園區

1. To ensures consistent implementation and compliance to external regulations including FDA Quality System Regulation (21 CFR Part 820), ISO 13485 & ISO 14971.2. Define and support the Quality Unit and Process Development stream in the implementation of risk-based global validation strategy and Quality Management System.3. Provide input for product lifecycle to ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters. 4. Provide input on non-conformance events, Change Control and Corrective Actions and Preventive Actions (CAPA).5. Participates and hosts internal and external audits to ensure quality compliance.

Hsinchu County/City, Taiwan

Accomplishments & Experience1. Supplier management and qualification of several projects (total budget around 3 million Euro) with Europe company.2. Ensure that the validation and compliance requirements are met according to international guidelines (eg. USP, WHO, ATMP) and local regulations (eg. PIC/S GMP, GTP). Execution of qualification and validation including computer system, process, facility, utility and equipment system.3. Ensuring that products can conform regulatory requirements in Taiwan based on quality management system (QMS) including the quality risk assessment, impact assessment , deviation and change control.4. Participates and hosts internal and external audits to ensure quality compliance.

1. Tasks include: in vitro propagation of PRRSV, conducting and implementing the field trial of swine vaccine, evaluation of vaccine efficacy through target or non-target animal experiment.2. Develop, optimize and conduct quantitative studies via real-time PCR.3. Conduct experiment including cell/bacterial culture and virus/protein purification.4. Liaise with other members of the research project to establish a working relationship and work collaboration with other research staff at the partner organizations.5. Provide monthly status report of assigned projects and update the quality metrics

1. Identification and characterization of molecular mechanism involving in habenular axon guidance. 2. Regular care and maintenance of a zebrafish (Danio rerio) laboratory.3. Conduct experiment including cell/bacterial culture, molecular biology, gene cloning, transfection, protein purification and Confocal microscope.4. Collate and present experimental results to professor at regular meeting. 5. Preparation of reports and presentations at zebrafish-associated conferences.

Master'S Degree, Biochemistry And Molecular Biology

Activities and Societies: Basketball team Master thesis: Effect of carboxyl terminus of Helicobacter pylori GroES on IL-8 expression.

Bachelor'S Degree, Animal Sciences

Activities and Societies: Basketball team

Education record

Activities and Societies: Guitar Club