锦鲤求职岗位描述
MSAT偏差调查专员
MSAT Deviation Investigation Specialist
· 具备较强的逻辑思维能力，熟悉常用偏差调查工具（如鱼骨图、5-Why等），能够系统性地分析问题并提出解决方案。必须至少主持过一次偏差调查或其它异常调查（面试时需进行案例介绍，可脱敏处理）。
Strong logical thinking skills; familiar with common deviation investigation tools (such as Fishbone diagram, 5-Why, etc.); capable of systematic root cause analysis and proposing solutions. Must have led at least one deviation or other investigation (case study presentation required at interview, with sensitive information omitted).
· 优秀的中英文口头及书面沟通能力，能够流畅撰写技术报告，并与内部团队、客户及审计人员有效交流。
Excellent communication skills in both Chinese and English, oral and written; able to write technical reports fluently and communicate effectively with internal teams, clients, and inspectors.
· 熟悉GMP基本要求、有GMP体系工作经验者优先。
Familiarity with basic GMP requirements and experience working within a GMP system are preferred.
· 拥有CHO细胞培养或抗体纯化工艺研发/生产经验者优先。
Experience in CHO cell culture or monoclonal antibody (mAb) purification process development/production is preferred.
· 熟练使用AI大语言模型工具（如ChatGPT、Copilot等）者优先。
Proficiency in using AI large language model tools (such as ChatGPT, Copilot, etc.) is preferred.
· 本科及以上学历，生物、化学、化工、制药工程或相关专业，或具备同等工作经验。
Bachelor’s degree or above in Biology, Chemistry, Chemical Engineering, Pharmaceutical Engineering, or related fields, or equivalent work experience.