上海招聘

Key accountability:

1. Review analytical raw data, records and related reports/CoA/ROA etc produced in Analytical R&D. Ensure all analytical activities are performed according to effective protocol/method/memo or other GMP document. Ensure all activities and records are GMP compliance.

2. Coordinate OOS/OOT/OOA, deviations, CAPA, making sure the corrective or preventative actions are carried out and documented and maintaining the trace system to prevent deviations from re-occurring.

3. Coordinate change control, making sure any change is documented according to defined procedure and all impacted items are investigated.

4. Periodical quality evaluation

5. Train lab scientist on GMP compliance periodically

6. Related SOPs writing, revision and reviewing.

7. Any job and responsibilities assigned by direct supervisor.

Core business/Functional skills and education:

1. Must have experience in GMP.

2. Must be trained in or have experience with the requirement of SFDA, FDA, EMEA GMP regulation and ICH guideline.

3. Must have analytical R&D working experience or related background

4. BS, MS or Ph.D. degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in pharmaceutical analysis

5. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.

6. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

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。