Sr. specialist, Lab Support — Roche

Role overview

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.

The Position Principle Roles &

• Responsibilities / Accountabilities 主要职责/责任 ● Ensure that the following works are effectively executed to support LS and QC related business 确保如下工作被有效执行，以支持QC相关业务 ⮚ Roche Global digital system aspect, including but not limit to 罗氏全球数字化系统相关，包括但不限于 ● Responsible for the deployment of the end-to-end process for BIOVIA (Electronic Lab Notebook).

Drive the implementation of QC electronic analytical records and system integration in a project management approach, including formula development, formula testing, formula validation, formula optimization and integration, as well as system interaction testing and application.

负责BIOVIA (Electronic Lab Notebook) 端到端流程的部署。以项目管理的方式逐步推进QC电子分析记录和系统交互建立，包括配方开发，配方测试，配方确认，配方优化和融合，系统交互测试和应用等 ● Utilize QbD thinking to ensure end-to-end compliance of Roche's global digital systems.

This includes eliminating GMP and Data Integrity risks, simplifying and optimizing processes, and improving Right-First-Time performance.

运用QbD思维，确保罗氏全球数字化系统端到端流程全面合规。包括消除GMP和Data Integrity风险，简化&优化流程，提高Right-First-Time。 ● Roche global digital systems directly associated with testing such as BIOVIA, SingleLIMS，Labx, Empower, SAP.

Including creation of user processes, using and maintenance

• Creation of Master Data/Method and it's processes, using and maintenance etc.

其他罗氏全球数字化系统，如LIMS，Labx，Empower，SAP等的使用和维护等 ⮚ Laboratory testing and related work, including but not limited to: 实验室检测及相关工作，包括但不限于 ● Inspect and examine samples from processes such as packaging, excipients, finished product manufacturing, in-process control, environmental monitoring, change control, and customer complaints, providing timely and accurate analytical results and reports, as well as supporting trend analysis.