质量合规工程师 Quality Compliance Engineer

工作职责：

1.参与并支持内外部审计，包括但不限于：审计准备与接待 / 现场审计陪同与解释 / 回应审计意见并协调整改措施的落实；

Participate in and support audits, including preparation, hosting, on-site accompaniment and explanation, responding to observations, and coordinating corrective actions;

2.负责新产品引入安全性评估，掌握多产品共线风险评估逻辑（HBEL/PDE计算）；

Lead safety assessments for new product introduction, including multi-product campaign manufacturing assessment logic (HBEL/PDE calculation);

3.具备微生物污染控制知识，评估和优化微生物控制策略，在发生偏离时开展彻底的调查；

Apply knowledge of microbial contamination control to evaluate and optimize control strategies, and conduct thorough investigations when excursions occur;

4.设备引入评估/厂房设计的基础知识，主导或参与设备引入评估，厂房整体风险评估（如生产车间、洁净区布局、人物流走向、压差分区）以及厂房改造评估工作；

Possess basic knowledge of equipment introduction and facility design. Lead or participate in equipment introduction assessment, facility risk assessment (e.g., cleanroom layout, material/personnel flow, pressure differential zoning), and facility renovation assessment;

5.熟悉相关GMP法规与指南，对新发布的适用法规进行差距分析；对FDA 483表格、警告信及其他工厂的审计发现项进行差距分析并分享见解；

Conduct gap analyses for newly issued regulations, as well as for FDA 483s, warning letters, and audit findings from other sites. Share insights with the team;

6.起草并审核GMP文件，包括但不限于：SOP、方案、报告、培训材料、验证方案、验证报告等；

Draft and review GMP documents, including but not limited to SOPs, protocols, reports, training materials, validation protocols, and validation reports;

7.参与偏差的发起与调查、变更控制的发起与执行、CAPA的实施；

Participate in deviation initiation and investigation, change control initiation and execution, and CAPA implementation;

8.运用FMEA、PHA等风险评估工具，撰写质量风险评估文件；

Author quality risk assessment documents using risk assessment tools such as FMEA and PHA, etc.;

9.负责质量相关流程的建立与优化（如偏差流程管理，异常事件管理流程，SME管理流程等）并推动流程落地执行；

Establish and optimize quality-related processes (e.g., deviation management, abnormal event management, SME management), and ensure effective implementation;

10.新任务承接与探索（如AI工具的探索与推广），能够主动学习并推动落地；

Take on and explore new tasks (e.g., AI tool exploration and promotion), with the ability to proactively learn and drive implementation;

11.合规文化的建设及推广，组织策划全员合规活动与培训。

Build and promote a compliance culture; organize and plan compliance activities and training.

岗位要求：

1.制药相关专业本科及以上教育背景，具备GMP基础；

Bachelor's degree or above in pharmaceutical or related field, with basic GMP knowledge;

2.熟悉NMPA，FDA，EU等GMP法规及指南；

Familiar with NMPA, FDA, and EU GMP regulations and guidelines;

3.良好的协调沟通能力，能有效推动跨部门协作；

Strong coordination and communication skills, able to effectively drive cross-functional collaboration;

4.具备独立思考及解决问题能力，责任心强；

Independent thinking and problem-solving skills, with strong sense of responsibility;

5.具备流程建立、推广及落地执行能力（能推动流程从设计到真正落地）；

Ability to establish, promote, and implement processes (from design to full execution);

6.良好的中英文口头/书面沟通及数据展示能力；

Good oral and written communication skills in both Chinese and English, with data presentation ability;

7.具备主动学习、深入思考及探索新知识的能力；

Proactive in learning, deep thinking, and exploring new knowledge;

8.熟练使用Office办公软件及AI 等工具；

Proficient in Microsoft Office and AI tools;

9.擅长PPT制作并具备汇报能力；

Skilled in creating high-quality PPTs and delivering presentations;

10.具备全员合规活动的组织与策划能力。

Capable of organizing and planning compliance activities.