北京招聘

工作职责:

1. Conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary.

进行机构审查、特别审查、计算机化系统审查、供应商/承包商审查等，如有必要，进行SOP审核。

2. Conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc.

进行基于研究项目的审查，包括方案审查、实验阶段审查、数据审查、报告审查和报告确认审查等。

3. Promptly report any inspection results in writing to Test Facility Management and to the Study Director, and to the Principal Investigator(s) and lead Quality Assurance and Test Site Management for multi-study, and to the respective management, when applicable; Follow up implementation of CAPA, when applicable.

及时将检查结果以书面形式汇报给机构管理层和专题负责人，对于多场所项目，还需汇报给主要研究者，主场所质量保证负责人和分场所管理层及相关负责人（如涉及）。跟踪预防纠正措施（如涉及）的实施。

4. Assist inspections by client or regulatory agency when necessary.

如有必要，协助客户及法规机构的审计。

5. Assist and advise QA management on quality system improvement.

协助和建议QA管理层改进质量体系。

6. Support other quality systems out of BAS test facility when necessary.

如有必要，支持生物分析部以外的其它质量管理工作。

7. Conduct work described in the related SOPs and according to OECD, US FDA and NMPA, etc., GLP, GCP, 21CFR Part 11 guidelines as well as other applicable regulations.

进行SOP中规定的相关工作，以及根据国际经贸合作组织，美国食品药品监督管理局，中国国家药品监督管理局等GLP，GCP，21CFR part 11法规或其它适用法规规定的相关工作。

8. Maintain QA files.

维护QA文件。

9. Conduct the work delegated by QA management.

进行QA管理层分配的其它工作。

任职资格:

1. Have the ability to understand the basic concepts underlying the activities being monitored. Have a thorough understanding of GLP, GCP, 21CFR Part 11 guidelines as well as other applicable regulations.

理解所监管活动的基本概念。深入理解GLP，GCP，21CFR part 11法规或其它适用法规。

2. Be familiar with the test procedures, standards and systems.

熟悉测试步骤，标准和测试系统的内容。

3. Be skillful at reading, understanding and writing English documentation.

良好的英文阅读，理解和书写的能力。

4. Have good communication skills, both written and verbal, and work in a team-oriented manner.

良好的书面、口头表达能力及团队协作能力。

5. BS, MS or Ph.D. degree in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience.

具备化学、药学或相关专业背景、培训及同等经历。

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。