Director Of Quality and Regulatory

• 2022 年 3 月 - - 至今

Advisor of Quality and Regulatory Management

• 2021 年 12 月 - - 至今

Manager Of Quality and Regulatory

• 2021 年 8 月 - - 至今

Quality and Management

• 2000 年 1 月 - - 至今

Sara Webster is a highly skilled professional with over 10 years in the Quality System arena. I have implemented Quality Systems in its entirety, mainly in Start-Ups. I have created Document Control Systems, NON-Conformance and CAPA Systems, Audit Systems, Training Systems, Quality Control Systems etc. I have directed, guided and implemented quality without the overburdening of quality. I have lead and guided people through the process of performing risk analyses/assessments, change control and product control to help them make sound decisions when making recommendations for the development and improvement of products and processes while ensuring the risk is minimal and acceptable. I work with the vendors and/or suppliers to ensure that both parties come to a mutual understanding of acceptability of assemblies, sub-assemblies, tools, supplies or products.Although My experience is mainly in the Biotech/Pharma industry, I am able to apply the Quality System standards across any industry and across many countries. I have consulted with oil terminals to ensure the Quality Systems were in compliance and to create risk-based solutions. I have consulted with electrical parts manufactures as well as Medical Device and Pharmaceutical companies. I am also an advocate of continuous improvement in all areas.As a consultant, it is required that I become very familiar with the products and process and any relevant regulatory standard very quickly in order to recommend or implement any actions, if needed, for continuous improvement. I am very versed in quality issues and understand the relevance across all industries and applies what is needed to assist businesses in their continued growth. My philosophy is: It is the team that grows the company. Guidelines and regulations: .CFR, ISO/EN, EEC.ICH, MOTEMS, etc.

Senior Consultant

• 2018 年 3 月 - 2021 年 9 月

Quality Systems and Regulatory Consulting Quality Systems and Regulatory Consulting

Data Packet Manager

• 2020 年 12 月 - 2021 年 6 月

Quality Manager Consultant

• 2010 年 - 2010 年

Manage and enhanced the Quality System through development, implementation and maintenance of quality system procedures and activities in compliance with domestic and international regulations. Manage and enhanced the Quality System through development, implementation and maintenance of quality system procedures and activities in compliance with domestic and international regulations.

Quality Engineer

• 2005 年 7 月 - 2009 年 12 月