Job Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Implement GMP compliance with global GMP standards and China GMP requirement

根据总部和中国 GMP要求，完善 GMP的实施工作

• By assisting manager to conduct GMP self- inspection, and following-up the implementation action to maintain the global level of GMP compliance.

协助经理实施 GMP自查，跟踪改进实施计划，维护全球性的 GMP实施水平

• By maintaining the quality system and documentation system to ensure quality system operation in QC meet the regulatory requirement.

通过维护质量体系和文件系统，确保质量保证部的质量运作体系符合法规要求

Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.

实施样品分发和检验过程的管理职责，保证检验报告及时放行，以支持业务需要。

• By managing working schedule of relative section, to optimize utilization of human resources.

管理相关领域的工作计划，优化人员使用效率

• By monitoring the timely calibration and maintenance of instrument within working section, to ensure they are functional well.

监控工作领域内仪器的按时维护、校验和保养状况，以保证仪器设备的正常使用

• By monitoring the timely entering and complementing of lab materials, including but not limit to reagent, solution, column/capillary and reference standard in working section, to ensure sufficient supply.

监控工作领域内实验室物料的录入和补充状况，包括但不仅限于试剂、试液、色谱柱&毛细管、标准品等，以 保证正常足量供应

Project management and process management

项目管理和流程管理

• Responsible for the implementation and transfer of new bioanalytical technologies

负责生物分析新技术的落实和转移

• Responsible for communicating with external collaborative projects

负责与外部协作项目的沟通

• Responsible for the SOP formulation, opinion collection and optimization for QC research project process management

负责 QC研究型项目流程管理 SOP的制定、意见收集和优化

• Responsible for tracking the progress and data summary of bioanalysis lab research projects

负责跟踪生物分析实验室研究型项目的进度和数据汇总

Complete the assigned routine testing, issue the reliable analytical report in reasonable lead time.

完成分配的日常检验样品，在合理的分析周期内签发正确的分析报告

• By mastering analytical methods within working section, complying with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.

熟练掌握工作领域内的分析方法，遵守职业道德和操守，确保分析数据的可靠性和完整性，具备良好的工作适应能力。

• By rationalizing time allocation, optimizing combination the samples in hand to keep the reasonable lead time.

通过工作时间的合理分配，优化待分析样品的组合，保持合理的分析周期。

• By forming a good working habit to standardize experimental operations.

养成良好的工作习惯，规范实验操作。

• By checking analysis result seriously and carefully to minimize mistakes and ensure accuracy and reliability of testing figures.

通过认真仔细地复核分析记录，尽量减少差错，保证数据的准确性和可靠性。

Report the abnormal status, unexpected results to supervisor with initiative and in time.

及时主动地向上级通报非正常状况和实验结果。

• By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.

实验过程中发现的非正常状况和实验结果应在第一时间向上级通报详细数据和信息，以提示上级进行调查并及时正确的解决问题。

• By involving the investigation process to provide actual data and information to help avoid the same issue occurring again.

参与调查过程，提供真实的数据和信息，以帮助避免类似问题再次出现。

Implement the analysis method validation.

实施分析方法验证

• By initiating the specified analysis method validation via planning, executing and reporting process.

通过计划、实施和报告阶段启动指定的分析方法验证工作。

• By organizing the resources to complete yearly method validation plan.

通过组织资源、完成年度方法验证计划。

Implement the maintenance and calibration of the assigned instruments

实施分管仪器的维护、校验和保养工作。

• By accomplishing the calibration and maintenance of the assigned instruments, to ensure they are functional well to meet the analytical needs any time.

完成指定仪器的维护、校验和保养工作，确保仪器设备随时满足分析需要。

• By keeping the relevant document to trace the calibration & maintenance history and any change of the instruments.

保管相应文件，以便追溯仪器的维护、校验和保养历史以及所有变更

• By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time.

保持与仪器公司联系，以及时获得足够的仪器应用的技术支持。

Qualification and Experience 能力与经验

Education/Qualifications 教育程度/所获资格证书

Bachelor of Science Degree or above 理学士及以上学位

Pharmacy, Chemistry, Biochemistry and equivalent 药学、化学、生物化学及相关学科

Master at analytical science of Biological Product;精通生物制品分析技术

At least 4 years’ experience in analytical testing and method validation of biologics

至少4年生物制品测试、方法验证的经验

At least 2 years’ experience of project management.

至少有2年项目管理的经验

Job Required Competencies 岗位所需胜任力

Project management skills 项目管理能力

Leading team capability 团队领导能力

Language skills – English & Chinese 语言能力-英语及国语

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.