Overview
质量控制原辅料主管 Jobs in Suzhou, Jiangsu, China at 中国平安人寿保险股份有限公司广东分公司
Title: 质量控制原辅料主管
Company: 中国平安人寿保险股份有限公司广东分公司
Location: Suzhou, Jiangsu, China
该职位来源于猎聘 Job responsibility 工作职责 Laboratory equipment 实验室仪器设备
- Manage and perform and/or support equipment and QC support systems, ensure the lab is in clean status; 管理、执行以及/或支持仪器设备和QC辅助系统,确保实验室处于整洁有序的状态；
- Ensure calibration and maintenance is within expiration date basing before use; 确保仪器在使用前其计量和/或维护在有限期内；
- Initiate, review and revise related equipment operation procedure. 起草、审核和更新 相关仪器的操作流程。 Testing 检验
- Conduct compendial method: ID testing, physical and chemical test, bacterial endotoxin and microbial limit testing; 执行药典常规方法：鉴别测试、理化测试、细菌内毒素和微生物限度测试；
- Be familiar with basic testing methods of raw material; 熟悉相关原辅料基本检测方法；
- Initiator and review methods and procedures for completeness and accuracy; 起草方法操作规程和其他管理规程，审核其完整性和准确性；
- Good time management skills to ensure smooth implementation of projects. 具有很好时间管理能力，以确保项目的顺利实施。 Data Management 数据管理
- Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data; 对记录、计算、编辑、解释、审核以及录入数据负责；
- According to different pharmacopeia, do gap assessment for material.
依据不同的药典，对物料进行差距分析。 General 常规要求
- Comply with general Company Policies and Procedures. 遵守公司政策和程序；
- Assist QC manager to complete other work if needed. 如需要协助QC经理完成其他相关工作 Safety and environment 现场安全和环境合规
- Promote a culture of safety work place through personal actions;
以身作则推动建立安全的工作环境；
- Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序 Quality Assurance 质量要求
- Comply with the Company Quality Management Systems; 遵守公司质量管理体系;
- Initiate new and revise documents, participate in investigation teams, and provide input to quality systems (change control, CAPA, deviations, OOS and Risk assessment, etc.);
起草新文件和修订文件，参与调查团队并且在质量体系运营中（变更、CAPA、偏差、OOS和风险评估等 ）提供支持；
- Comply with GLP and cGMP, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books. 遵守GLP和cGMP的要求，包括但不限于：培训记录、实验室记录、书面规程、仪器设备监控系统和实验室工作日志的维护。 Qualifications 任职资格
- BS degree in Chemistry, Biochemistry, Microbiology, Molecular/cell biology or a related discipline; 化学、生物化学、微生物学、分子/细胞生物或其他相关领域学士学位；
- Minimum 3 years of QC relevant experience in Anti-body/Bio-pharmaceutical/Vaccine industry; 至少3年抗体、生物制药或疫苗等行业QC相关工作经验；
- Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, USP, EP, cGMP; 具有国标、中国药典、美国药典、欧洲药典和cGMP等法规关于生物药品检测知识；
- Working knowledge and hands-on test experience in relevant industry; 有相关工业领域工作知识和检测实操经验；
- Working knowledge and hands-on Ability to analyze data, troubleshoot; 具有数据分析、异常结果原因分析的能力；
- Ability to be trained and work closely with other function; 具有被培训和能够与其他部门同事共同合作的能力；
- Excellent communication skills (both verbal and written) and interpersonal skills are required, fluent in English and Chinese; 较好的沟通能力（口语和写作）以及人际交往能力，中英文流利；
- Excellent structured organization skills to meet tight deadline. 优秀的组织能力，能够在截止时间前完成相应工作。 Preferred Experience 优先考虑
- Adequate understanding of ICH Quality guidelines, including: stability program, quality of biotechnological products, pharmaceutical quality management, and quality risk management;
熟悉ICH质量指南，包括：稳定性程序，生物技术产品的质量，制药质量管理以及风险管理；
- Expert knowledge of Good Manufacturing Practice of China, EU, and USA related to Quality Management Systems and Quality Control; 熟悉中国cGMP，欧盟cGMP以及美国的相关质量管理体系和质量控制法规；
- Sound understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities; 熟悉中国药典、美国药典和欧盟药典的区别，以及其中生物制品和关键公用设施的内容；
- Thorough understanding of Mab development, manufacturing, and analytical process. 熟悉单抗的开发、生产和分析。
