长沙招聘

职位描述：
Key accountabilities:

1. Be responsible for reviewing and approving the batch records and ensuring the operation complies with defined procedures.
2. Be responsible for ensuring that raw materials, packaging materials and intermediate, bulk and finished product are approved or rejected, stored, distributed and subsequently handled according to defined procedure or specification.
3. Be responsible for reviewing and approving deviation and changed control.
4. Be responsible for taking part in investigation, documentation and communication of GMP nonconformity.
5. Be responsible for QA related SOP’s writing, revision and reviewing.
6. Any jobs and responsibilities assigned by Vice President GMP QA.

Requirement:

1. Must have 8+ years experience in GMP quality assurance for oral dosage.
2. Must be trained in or have experience with the requirement of SFDA, FDA, EMEA GMP regulation.
3. Good understand of Quality System regulations and requirements and ability to assess and implement improvements to the existing system.
4. BS, MS or PH.D degree in a science discipline with experience or training in Chemistry Pharmaceutical, or equivalent experience.
5. Strong organization, communication and teamwork skills to be able to effectively interact within multidisciplinary groups. 举报 分享

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。