长沙招聘

1. Participate in facility-based/process inspection and contractor audit if necessary;
2. Conducting study related audit; include plan/protocol review, experimental phase inspection, data audit and report audit, and issue the audit report timely;
3. Report any significant problems which are likely to affect the integrity of a study immediately to the study director, principal investigator (PI), and laboratory/ facility management (as appropriate);
4. Assist and advise QA management on quality system improvement;
5. Conduct audit on the computerized system when necessary;
6. Conduct vendor audit and review SOP when necessary;
7. Maintain QA documentation when necessary (e.g., org chart, study master schedule, trendy analysis)

Core business/Functional skills and education:

1. Must be trained in or have experience with the requirements of the FDA GLP regulations and CFDA, OECD GLP guidelines as well as other applicable regulations (e.g., ICH GCP)
2. BS, MS OR Ph.D. degree in a science discipline with experience or training in Chemistry, pharmaceutical, or equivalent experience
3. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
4. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

Scope of the job:

1. All work will be conducted in compliance with FDA Good Laboratory Practice regulations, OECD, CFDA GLP guidelines as well as other applicable regulations (e.g., ICH GCP).

2. Be expected to work closely with management team for the development of QA department

3. Be expected to perform the job independently with limited supervision from management. Must be customer-oriented and able to show flexibility and quick responsiveness in moving from one project to another. QA auditor with appropriate skill sets and experience will assist in other quality functions on an as-needed basis.

4. Individuals will be expected to accomplish their work assignments by interacting closely with test facility and by developing cooperative working relationships with other personnel inside the company. Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.

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。