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无工作经验 -
招若干人 -
11-09 发布
职位描述
职位描述： Quality Compliance & Training Senior Specialist This position mainly focus on quality compliance, inspection related activities (such as client audit and on-site inspection preparation & support) and training activities. For these tasks, we do expect some experienced and mature persons (such as experienced Sr. Specialist) with good professional knowledge and interpersonal skills. JOB DESCRIPTION1. Following good documentation practice to build up and maintain good documents control system in quality control system.2. Manage compliant report, adverse event report and field safety action, maintain the relative quality record.3. Monitor / support the CAPA to be implemented in QC effectively.4. Provide advice and training on compliance policies and regulations.5. Coordinate with compliance specialists in rest of company.6. Support the QC managers for training arrangement, including participants notice, training documents, training facilities and organize diversified training activities.7. Analyze training data to optimize operation process and maintain learning management system.8. Be the internal auditor to conduct internal QMS audit in QC organization. PERSONAL QUALIFICATION1. Bachelor’s degree or above defined as related Biopharma/Analytical field.2. No less than 5 years’experience in the conduct of QC operations or quality management.3. Excellent insight into GMP and QC lab operations.4. Good written, oral communication, presentation, and computer skills.5. Read, write, and speak fluent English. 职能类别： 生物工程/生物制药
联系方式
上海市外高桥保税区富特中路288号
公司信息
药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/
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