锦鲤求职岗位描述
Job Description – Quality System QA
职位描述 – 质量体系QA
Job Summary Participate the optimization activities to the Quality System to ensure compliance with global GMP standards and support XDC’s business and product needs.
工作概述 参与质量体系优化工作，以确保其符合全球GMP标准，同时满足XDC的业务和产品需求。
Key Responsibilities
主要职责
* Participate in the optimization of processes such as deviations and changes.
参与偏差、变更等流程的优化
* Assist in establishing a phased quality system suitable for clinical and commercial stages.
协助建立适用于临床和商业阶段的分阶段质量体系。
* Contribute to drafting quality management review reports, deviation review reports, etc., analyze key data within the quality system, and develop effective measures.
参与撰写质量管理评审报告、偏差回顾报告等，对质量体系中的重要数据进行分析，并建立有效的措施
* Support other quality system activities, such as change control, complaint handling, and recall management, while performing process optimization and data analysis.
支持其他质量体系活动，如变更控制、投诉处理和召回管理，并进行流程优化和数据分析。
* Perform additional tasks as assigned by leadership.
执行领导分配的其他任务。
Qualifications
任职资格
* Bachelor’s degree or above in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related fields. 生物制品、药学、制药工程、生物工程或相关领域本科及以上学历。
* About 3-10 years of QA experience in biopharma or pharmaceutical industries.
生物制药或制药行业3-10年QA经验。
* In-depth knowledge of FDA, EMA, and PIC/S GMP requirements.
深入了解FDA、EMA和PIC/S GMP要求。
* Proven experience in quality system management (e.g., deviation management, change control).
具有质量体系管理经验（如偏差管理、变更控制）。
* Familiarity with biologics manufacturing and quality control requirements.
熟悉生物制品生产和质量控制要求。
* Experience across multiple development phases (research, clinical, commercial) preferred.
具有多个开发阶段（研究、临床、商业）经验者优先。
* Strong English proficiency (listening, speaking, reading, writing).
具备较强的英语能力（听、说、读、写）。
* Proficient in Microsoft Office (Word, Excel, PowerPoint).
熟练使用Microsoft Office（Word、Excel、PowerPoint）。
* Excellent analytical, problem-solving, and logical thinking skills.
具备优秀的分析、解决问题和逻辑思维能力。
* Strong communication and collaboration across functions.
具备跨职能的沟通与协作能力。
* Demonstrates ownership, adaptability, and conflict resolution skills.
具备责任感、适应能力和冲突解决能力。