Key Responsibilities 主要工作职责:
1、Document Review & Client Deliverables 文件审核与客户交付：
1.1、Review and approve all technical documents (e.g., Certificates of Analysis, validation reports, quality agreements) submitted by the factory to clients, ensuring accuracy, compliance, and alignment with client-specific requirements.审查并批准工厂提交给客户的所有技术文件（如分析证书、验证报告、质量协议），确保准确性、合规性并符合客户的具体要求。
1.2、Lead pre-audit assessments of critical documents to identify and mitigate compliance risks before client audits.在客户审计之前，牵头对关键文件进行审计前评估，以确定并降低合规风险。
2、Regulatory Compliance Oversight 法规合规性监督：
2.1、Monitor the factory’s quality management system (QMS) to ensure adherence to global and local regulations, including China GMP, ISO 9001/13485, FDA 21 CFR, EC178/2002, etc.监控工厂的质量管理体系（QMS），确保符合全球和本地法规，包括中国 GMP、ISO 9001/13485、FDA 21 CFR, EC178/2002等。
2.2、Track updates to domestic and international regulations (e.g., China GB, EU MDR, U.S. FDA guidelines) and guide the factory on necessary process adjustments.跟踪国内外法规（如中国GB、欧盟 MDR、美国 FDA 指南）的更新，指导工厂进行必要的流程调整。
3、Cross-functional Coordination 跨部门协作与沟通：
3.1、Act as the primary quality interface between the Shanghai HQ and Chongqing factory, providing monthly reports on quality KPIs (e.g., deviation rates, Customer complaints, CAPA closure timelines, etc.) to the General Manager.作为上海总部和重庆工厂之间的主要质量接口，每月向总经理提供质量 KPI 报告（如偏差率、客户投诉、CAPA 关闭时间表等）。
Qualifications 任职要求:
1、Bachelor’s degree or above. Prefer a degree in a Food Science, Food Engineering, Chemical Engineering, Bioengineering, Pharmacy, or related fields.本科及以上学历。食品科学、食品工程、化学工程、生物工程、药学等相关优先。
2、Fresh graduates or candidates with 1-2 years of work experience in Quality QA/QC.应届毕业生或1-2年质量岗位经验。
3、Proficiency in English and Chinese, both written and spoken.熟练的中、英文书面和口语表达能力。
4、Well-organized, detail orientated. Ability to establish close communications and working relationships with cross functional teams to meet business objectives.条理清晰，注重细节。能够与跨职能团队建立密切的沟通和工作关系，以实现业务目标。
5、Proficient in technical documentation writing and review (e.g., batch records, COAs, stability studies), and able to quickly identify data logic gaps.精通技术文档（例如批记录、COAs、稳定性研究等）撰写与审核，能快速识别数据逻辑漏洞。
6、Knowledgeable in GMP’s, inspection/auditing guidelines, sanitation, food regulations (FDA / EFSA, etc.), pest control, and product safety.熟悉 GMP、检查/审计准则、卫生、食品法规（FDA / EFSA等）、虫害控制和产品安全。
7、Proficiency with Microsoft Office Applications.熟练使用Microsoft Office办公应用程序。
请注意：本岗位base在重庆，非诚***。