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.

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.

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.

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.

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.

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.

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.

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.

 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