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 Roches 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 SingleLIMSLabx Empower SAP. Including creation of user processes using and maintenance; Creation of Master Data/Method and its processes using and maintenance etc.
其他罗氏全球数字化系统如LIMSLabxEmpowerSAP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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.