北京招聘

Job Purpose

To perform the role of Quality Assurance Associate, assist QA Manager in maintaining quality system, including deviation, change control, validation/qualification and complaint. Ensure above activities in compliance with Fisher Clinical Logistics Global Policy, all relevant regulation and industry recommended practice applicable to the distribution of clinical trial materials.


Major Duties and Responsibilities

To assist the QA Manager in ensuring that clinical trial materials distributed by FCL meet all quality and regulatory requirements, by taking specific responsibility for the following.

Maintenance of the quality system.
Management and administration of the Trackwise deviation and CAPA system.
Management of the self inspection system, arranging and performing internal audits. Follow up the implementation of actions timely.
Manage and monitor change control system.
Monitor product complaint handling, and if necessary product recall.
Perform pre and post review and approval of production batch records.
Management of validation/qualification system. Review and approve validation protocol and record as the QA representative. Perform periodic validation history review.


Competencies / Other Requirements

?Bachelor’s degree in life science, chemical or related medical/ pharmacy.
?2+ years QA and Production experience minimum. Preferably experience of working in pharmaceutical companies.
?Good communication skills.
?Good written and spoken English.
?Teamwork / ownership. Desire to play a key role in the management of the business, taking ownership of issues and driving initiatives to build a strong business.
?Problem Solving/Decision Making

Fisher Clinical Services is a part of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $1 billion, we have more than 3500 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.
辉士尔临床服务是赛默飞世尔科学公司的一部分，该公司是服务科学领域的全球领导者，帮助我们的客户能够让世界更健康、更清洁、更安全。公司年收入为 10 亿美元，我们拥有 3500 多名全球员工，为制药和生物技术公司、医院和临床诊断实验室、大学、研究机构和政府机构等客户以及环境和工业过程控制设置提供服务。