QC Analyst

岗位职责
1、Perform sampling, testing, documentation, and reporting of raw materials, packaging materials, water monitoring samples, and other laboratory samples according to approved methods and SOPs;按照批准的方法和SOP要求完成原材料、包装材料、水系统监测样品及其他实验室样品的取样、检测、记录和报告工作；
2、Support external contract testing activities, including sample coordination, issue escalation, and timely follow-up of testing reports;支持外部委托检验工作，包括样品协调、问题反馈及检验报告跟踪；
3、Ensure compliance with GMP, Data Integrity, applicable regulations, Novartis Quality Policies, and local procedures;确保所有活动符合GMP、数据完整性、法规要求、诺华质量政策及本地程序要求；
4、Support laboratory investigations, deviations, OOS/OOE activities, and implement CAPA actions within defined timelines;参与实验室调查、偏差及OOS/OOE活动，并按时完成CAPA行动；
5、Maintain laboratory equipment, reagents, reference standards, consumables, and records in a compliant state;维护实验室设备、试剂、对照品、耗材及相关记录的合规状态；
6、Complete required training and maintain technical competency to perform assigned laboratory activities;完成岗位培训并保持开展实验室工作的专业能力；
7、Follow Novartis HSE requirements and contribute to QC operational excellence and quality performance objectives;遵守诺华HSE要求，支持QC运营卓越和质量绩效目标达成。

岗位要求
1、Diploma or degree in Pharmacy, Chemistry, Pharmaceutical Engineering, Life Sciences, or related discipline;药学、化学、制药工程、生命科学或相关专业大专及以上学历；
2、Fluent in Chinese (oral and written)；Working knowledge of English;中文听说读写流利，具备基本英文工作能力；
3、Experience in a pharmaceutical QC laboratory or a GMP regulated environment is preferred;有制药企业QC实验室或GMP规范环境工作经验者优先；
4、Good documentation practices;良好的文件记录规范意识；
5、Commitment to data integrity and compliance;重视数据完整性与合规要求；
6、Hands-on experience with analytical techniques and laboratory equipment, e、g、 HPLC, UV, GC, AAS, IR, Biological Safety Cabinet, and Autoclave, with good understanding of laboratory practices;具备分析技术及实验室设备的实操经验，例如 HPLC、UV、GC、AAS、IR、生物安全柜和高压灭菌锅等，并熟悉实验室操作规范。