体系QA

• 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

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