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

职位描述

1.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。

2. 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。

3. 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。

1. 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.

2. 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.

3. 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.

任职要求

1. 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

2. 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

3. 抗压能力强，数据敏感，细节控。

1. Education & Background

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

2. Professional Skills

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

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