长沙招聘

KEY ACCOUNTIBILITIES:
1. To provide compliance service to work-class pharmacy and bio-pharmacy, audit GLP related facility, document and activity for large molecule quantitation in support of PK/PD/TK and immunogenicity in bio-analytical service department. All work must be conducted in compliance with CFDA, FDA GLP regulation and OECD GLP guidelines.
提供药学和生物药学的合规服务，审计生物分析服务部门在药物动力学，药效动力学，毒理学和药物免疫原性领域用于大分子定量分析与GLP相关的设施，文档和操作。所有工作必须遵循CFDA，FDA GLP法规和OECD GLP指导方针。
2. Review the study protocol, methodology, data generation and report relating to bio-analytical work. Make sure any deviation in GLP lab is resolved immediately and investigated potential impact on the study in time if any deviation will be generated from study protocol, methodology, regulation or SOPs.
审计和生物分析工作相关的研究方案，分析方法，数据和报告。如果在GLP实验室有任何违背研究方案，分析方法，法规或标准操作规程的操作，确保及时解决这些偏离并评估这些偏离给项目带来的潜在影响。
3. Observe all operation in GLP compliance, report any observation to SD/PI and text facility management during inspection.
观察所有在GLP实验室的操作，向研究项目负责人和测试机构管理层汇报所有检查中发现的问题。
4. Conduct daily lab inspection to keep lab clean and maintain consistent high level of compliance. Make sure all of instruments and reagents within the expiration date and notify related personnel to resolve any issue in time.
每天检查实验室，保持实验室整洁并符合法规要求。确保所有的仪器和试剂都在有效使用范围内；通知相关人员对发现的问题做出及时的处理。
5. Conduct process inspection of all studies.
检查所有项目的进程。
6. Coordinate with SD/PI and QA staff for timing of inspection/review and corrective actions to meet project timelines without compromising quality.
在保证质量的前提下，及时与项目负责人和质量保证部人员沟通并确定项目的时间节点。

REQUIREMENTS:
1. BS degree or above in biotechnology, medicine or other related field.
生物技术，药学或相关领域的本科以上学历。
2. At least three years working experience in QA or QC in immunochemistry or bio-pharmacy.
在免疫化学或生物药学领域至少具有三年以上担任QC或QA职位的工作经验。
3. Better be trained in or have experience with the requirements of the FDA GLP regulations and OECD GLP guidelines.
最好接受过FDA GLP法规和OECD GLP指导方针的培训或具有此方面的工作经验。
4. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
具备很强的口头和书面的沟通能力。
5. Be skillful at reading, understanding and writing English documentation.
熟练的英文阅读，理解和书写。
6. Be skillful at computer application including Microsoft PowerPoint, Excel, Word and Outlook.
熟练运用办公室自动化软件。
7. Have active attitude towards any rapid issue resolution and communication.
灵活应对突发事件。
8. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.
具备良好的团队合作精神。

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。