化学分析岗(审计+项目对接方向) Chemical Analytical Scientist/Senior Scientist (Audit & Project Coordination Track)(J13559)

专项审计支持 作为实验室的指定对外窗口，负责接待FDA、EMA及海外客户的现场审计（On-site Audit）与远程审计（Remote Audit）。 负责检查实验室的合规点，提前识别漏洞。 陪同审计官进行现场巡视，针对审计官提出的问题进行实时专业解答。 负责审计后CAPA（纠正与预防措施）的英文起草与跟进，确保整改逻辑符合国际GMP标准。

客户沟通与项目管理 对接海外Biotech/Pharma客户，针对项目各种问题进行日常英文沟通。 组织并主持实验室项目的各类客户沟通会。 针对客户提出的特殊检测需求，协调实验室资源，制定可行性方案并反馈。

技术文档支持 支持实验室各组出具各类专业英文报告。 跟踪ISPE、PIC/S及欧美关于高活药物生产/检测的专用指南，评估其对现有高活实验室设施与流程的影响。

Special Audit Support - Act as the designated external point‑of‑contact for the laboratory; host on‑site audits and remote audits by FDA, EMA and overseas clients. - Review laboratory compliance items and identify potential gaps in advance. - Accompany auditors during site walk‑throughs and provide real‑time professional responses to audit inquiries. - Draft and follow‑up on English‑language CAPA (Corrective and Preventive Action) documents post‑audit, to ensure remediation logic complies with international GMP standards.

Client Communication & Project Management - Liaise with overseas Biotech / Pharma clients for routine English‑language communication on project‑related matters. - Organize and chair various client meetings for laboratory projects. - Coordinate laboratory resources for ad‑hoc client testing requirements, develop feasible solutions and provide feedback to clients.

Technical Documentation Support - Support laboratory teams in preparing various professional English reports. - Track dedicated guidelines from ISPE, PIC/S, European and US authorities for high‑potency drug manufacturing and testing, and assess their impacts on existing high‑potency laboratory facilities and procedures.

教育与背景 分析化学、药物分析、药学或相关学科硕士及以上学历，具有海外留学或工作经历

专业技能 英语可以作为工作语言，口语流利；了解GMP规范和各国药典

抗压能力强，数据敏感，细节控。

Education & Background Master’s degree or above in Analytical Chemistry, Pharmaceutical Analysis, Pharmacy or related disciplines; overseas study or work experience.

Professional Skills English as a working language with fluent oral proficiency; familiar with GMP regulations and pharmacopoeias of various countries.

Strong stress tolerance, data‑oriented and detail‑minded.