生产质量合规工程师 Manufacturing quality compliance engineer

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。组织日常Walk through, 发现项整改 Participate in and support audits, including preparation, hosting, on-site accompaniment and explanation, responding to observations, and coordinating corrective actions. Organize regular walk-through, address findings and rectify issues detected.

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

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.

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 Process basic knowledge of equipment introduction and facility design, lead or participate in equipment introduction assessment, facility risk assessment (e.g. cleanroom layout, MAL/PAL, pressure differential zoning), and facility renovation assessment.

熟悉相关GMP法规与指南，主导法规差距分析。对FDA 483表格、警告信以及其他工厂的审计发现项进行差距分析并分享见解，确保潜在风险提前识别和控制。 Familiar relevant GMP regulation and guidance, lead gap analysis. Conduct gap analysis of FDA 483, WL, and audit findings from other sites, share insights with the team, identify potential risks and control.

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.

审计过程中作为SME负责相关主题内容的讲解，培训辅导部门内SME的持续提升以及整体迎检能力 Act as SME during audit for topics within the scope, train and coach SME to continuously improve audit capability.

定期分析审计数据，识别不利趋势和潜在的改善机会，组织相关团队和部门落实，跟踪改善计划和行动。 Analyze audit performance to identify adverse trends and / or potential improvement opportunities, coordinate with cross department to mitigate the potential risks.

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 executions, and CAPA implementation.

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, PHA, etc.

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.

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.

制药、生物等相关专业本科及以上教育背景，至少3年以上生物医药行业生产和质量相关工作经验 Bachelor’s degree or above in pharmaceutical, biologics related field, at least three years’ experience in bio-pharmaceutical or quality related work.

熟悉NMPA、FDA、EU等GMP法规及指南，有FDA、EMA或NMPA官方检查准备和迎检经验者优先。 Familiar with NMPA, FDA, and EU GMP regulations and guidelines.

良好的协调沟通能力和理解能力，能有效推动跨部门协作 Strong coordination and communication skills, able to effective drive cross-functional collaboration.

具备独立思考及解决问题能力，责任心强，学习意愿和能力强，深入思考能力 Independent thinking and problem-solving skills, with strong sense of responsibility.

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

良好的中英文口头、书面沟通以及数据展示能力 Good oral and written communication skills in both Chinese and English, with data presentation ability.

熟练使用office办公软件及AI工具, 擅长PPT制作并具备汇报能力 Proficient in Microsoft Office and AI tools, skilled in creating high quality powerpoint and delivering presentations.