Sr. specialist, Lab Support

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

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.
对包装，辅料，成品生产制造、制程控制，环境监测、变更控制和客户投诉等过程中的样品进行检验和检查，提供及时、准确的分析结果和报告以及支持趋势分析。

● Execute and support laboratory investigations of OOS, OOT, OOE, and other production-related issues, ensuring all analytical processes remain in a controlled state.
执行和支持实验室对OOS, OOT, OOE 及其它生产相关问题的调查，确保所有分析过程处于受控状态。

● Assist the laboratory manager in daily sample management, reference standard management, and stability sample management.
协助实验室经理处理日常样品管理、标准品管理、稳定性样品管理。

● Assist in laboratory GMP self-inspections, audits, and related inspection activities. Track the implementation of improvement plans to ensure the laboratory remains compliant with the latest GMP and DI regulations and Roche requirements.
协助实验室GMP 自查、审计等相关检查活动。跟踪改进实施计划，确保维护实验室满足最新GMP和DI法规和Roche要求。

⮚ Local instrument/equipment aspect, including but not limit to
本地仪器/设备相关，包括但不限于

● Management of the lifecycle process for instrument/equipment and execution of related business operations, including verification/validation of instrument/equipment, periodic review, backup/archive/recovery, internal and external calibration and testing, decommissioning, maintenance and repair, contracts and orders, etc.
仪器/设备生命周期流程的管理和相关业务的执行，如仪器/设备的确认和验证，周期性回顾，备份/归档/恢复，内外部的校准和测试，退役，维护和维修，合同和订单等。

● Complete the other tasks assigned by the leader.
完成上级领导布置的其他任务

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, microbiology and equivalent
药学、化学、生物化学、微生物及相关学科

● At least 4 years of relevant experience in laboratory analysis and/or QC digital deployment etc., within a pharmaceutical company.
至少4年在制药企业实验分析或/和QC数字化部署等相关经验

Leadership Competencies领导力

N/A

Job Required Competencies岗位所需胜任力

● Laboratory electronic system management and recipe development capabilities
实验室电子系统管理和配方开发能力

● Professional knowledge and good practice of physical & Chemical analysis and/or Microbial analysis and/or Bioanalysis 理化分析或/和微生物或/和生物分析专业知识和良好实践

● GMP and Pharmacopeia (e.g. ChP, EP, USP) implementation experience and deep understanding.
GMP和药典（e.g. ChP, EP, USP）实施经验和深刻理解

● Project Management skills
项目管理技能

● Knowledge of management of laboratory instrument/equipment
实验室仪器/设备管理知识

● Language skills – English – Good Listen/Speak capabilities
语言能力 - 英语 - 较好的听/说能力

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.