北京招聘

Job Summary:

To perform the role of Senior QA Associate, assist QA Manager in maintaining all necessary systems to ensure that quality assurance, and technical activities, required to meet business needs are fully adequate, and that Fisher Clinical Logistics fully complies with all legislation and industry recommended practice applicable to the distribution of clinical trial materials.

Responsibilities:

• To assist QA Manager in ensuring that clinical trial materials distributed by FCL meet all quality and regulatory requirements.
• Maintenance of the quality system.
• Management of the global document control system, including the creation, approval, issue, distribution, and withdrawal of controlled documents.
• Management and administration of the Trackwise deviation and CAPA system.
• Management of the self inspection system, arrange and perform internal and external audits.
• Review and approval of assigned corrective or preventive actions.
• Ensure the timely and satisfactory completion of such actions.
• Manage and monitor change control system.
• Monitor product complaint handling, and if necessary product recall.
• Monitor the performance of contractors in terms of efficiency, compliance and time.
• Highlight any potential issues and work to resolve such issues.
• Liaise with clients on quality related topics and/or issues.
• Collate data for analysis at Quality Management Review

Requirements:

• 3+ working experience with Strong QA and production experience, preferably in pharmaceutical companies.
• Good communication skills both in mandarin and English
• Ability/flexibility to work on a broad range of activities providing hands-on operational support.
• 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 and 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。