Iris Liu Email & Phone Number

Hsinchu, Tw

Tainan

1. Responsible for site quality management systems, GxP activities, and batch disposition2. Act as key member of the site leadership team and group quality leadership team3. Lead the Quality Assurance team (operational quality, quality systems, and compliance, validation) and Quality Control Team4. Responsible for staff training and developing the Quality organization5. Oversee all GxP activities (all activities associated with manufacturing, testing and release, facility, and utilities) at the site and ensure current Good Manufacturing Practices (cGMP) are being followed6. Responsible for ensuring Quality systems comply with most current regulatory requirements in the markets in which the company operates not limited to PIC/S, and TFDA7. Responsible for continuous improvement of these quality systems8. Oversee quality audits including external audits and internal audits as well as audit responses. Host customer/regulatory audits for the site9. Interface with Quality Personnel, cross functional personnel and external parties on quality issues and queries10. Responsible for managing batch disposition, recalls, and complaints (including product quality complaints and adverse events)11. Quality oversight of new product introduction, technology transfer, and support product registrations12. Quality oversight of management of suppliers and third parties (e.g., contract manufacturing, contract laboratories). Responsible for ensuring these suppliers and third parties meet the required quality requirements13. Responsible for managing the Quality department budget, headcount, and capital expenditure14. Provides quality oversight for Good Distribution Practices for the commercial15. Provides quality management for the in-licensing products to Taiwan market.

Taiwan

1. Define the strategies of materials control, stability program, GxP training program, documents control program and change control program to ensure compliance with regulations and procedures.2. Oversee the documents control program ensuring all GxP relevant documents are compliance and well control. 3. Cross-functional communication and projects initiative and deployment, also cooperate with customers to ensure GxP related changes are evaluated and implemented appropriately4. Be the role of chairperson of change control board meeting leading the communication of change control committees. Oversee the change control process ensuring the all GxP relevant changes are assessed and controlled appropriately.5. Oversee the training program ensuring the GxP relevant training and personnel qualification program are implemented and well controlled. 6. Oversee the materials/finished goods control/release and stability program ensuring the materials/finished goods and stability program are well controlled/released and compliance. 7. Supervise and provide direction to quality system staff and other department personnel on analysis and problem solving, professional behavior and development, personnel issues, etc.

Miaoli County, Taiwan

1. Define the strategies of materials control, stability program, GxP training program, documents control program and change control program to ensure compliance with regulations and procedures.2. Oversee the documents control program ensuring all GxP relevant documents are compliance and well control. 3. Cross-site/ cross-functional communication and projects initiative and deployment, also cooperate with global team to ensure GxP related changes are evaluated and implemented appropriately4. Be the role of chairperson of change control board meeting leading the communication of change control committees. Oversee the change control process ensuring the all GxP relevant changes are assessed and controlled appropriately. 5. Oversee the training program ensuring the GxP relevant training and personnel qualification program are implemented and well controlled. 6. Oversee the materials/finished goods control/release and stability program ensuring the materials/finished goods and stability program are well controlled/released and compliance. 7. Supervise and provide direction to quality system staff and other department personnel on analysis and problem solving, professional behavior and development, personnel issues, etc.

Taiwan

1. Define the strategies of GxP training program, documents control program and change control program to ensure compliance with regulations and procedures.2. Oversee the documents control program ensuring all GxP relevant documents are compliance and well control. Cooperated with Impax global computer system validation team to implement electronic documents management system in Taiwan site and launched the system successfully in 2015.3. Cross-site/ cross-functional communication and projects initiative and deployment, also cooperate with global team to ensure GxP related changes are evaluated and implemented appropriately4. Be the role of chairperson of change control board meeting leading the communication of change control committees. Oversee the change control process ensuring the all GxP relevant changes are assessed and controlled appropriately. Cooperated with global computer system validation team to implement TrackWise system Change Control Module in Taiwan site and launched the module successfully in 2014.5. Oversee the training program ensuring the GxP relevant training and personnel qualification program are implemented and well controlled. Lead the continuing improvement project to re-design the training curriculums for GxP relevant departments ensuring the training program is robust and efficiency.6. Supervise and provide direction to quality system staff and other department personnel on analysis and problem solving, professional behavior and development, personnel issues, etc.

Taiwan

 Responsible for ensuring that all GxP relevant practices and GxP relevant documents are compliance with Pfizer Quality System Manual.  Responsible to host the external audit and had the experiences of the audit of TFDA, INVIMA (Colombia FDA).  Develop and maintain Internal audit program ensuring the GxP relevant practices are compliance with regulations and Pfizer Quality Standards Develop and maintain recall practice in Taiwan Hsinchu site and perform the mock recall practice annually. Supervise the role of Compliance network member who is responsible to maintain the license of registration and provide the documents for registration. Supervise the role of packaging artworks design specialist who is responsible the artwork design and revision for packaging components

Taiwan Hsinchu

 Responsible for ensuring that all GxP relevant practices and GxP relevant documents are compliance with Pfizer Quality System Manual.  Responsible to host the external audit and had the experiences of the audit of TFDA, Korea FDA and Australia (PIC/S). Develop and maintain Internal audit program ensuring the GxP relevant practices are compliance with regulations and Pfizer Quality Standards Supervise the role of packaging artworks design specialist who is responsible the artwork design and revision for packaging components ensuring compliance with regulations and Pfizer Quality Standards Develop and maintain a suitable GxP training system to ensure compliance with applicable regulations and procedures.

Taiwan, Hsinchu

 In manufacture field to management packaging lines and sterilization manufacture plant for people management and ensure the efficacy of packaging/production meeting the demand of market Perform suitable training to staff ensuring all training is appropriately before operation and completed 100% the yellow belt certification to all staff for operation excellence prospective

Taiwan

 Maintain the supplier management program and quality agreement program ensuring the supplier qualification/ management program comply with regulations and company’s policies Responsible the artworks design and revision for packaging components ensuring it complies with regulations and company’s policies. A qualified auditor in Taiwan Hsinchu site and responsible external supplier audit for supplier management program and support the global audit to Taiwan’s supplier.  Handling the customer compliant program ensuring the customer compliant is compliance with site's procedures and company’s policies.

 Laboratory Management, To be an assistant manager to manage about 12-16 QC inspection people. Achievement: Approved by DoH’s GMP and ISO 9000/2000version inspection. Incoming materials receiving and approval. Raw material inspection-Protein purity analysis Finished goods testing approval Environment monitoring inspection and report

Master'S Degree, Business Administration And Management, General

College of Technology Management, National Tsing Hua University

Bachelor, Nutrition