Roche
Pharmaceutical
Sr.specialist,LabSupport
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. specialist, Lab Support at Roche. Skills: BIOVIA, Laboratory analysis, GMP. Execute digital system deployment. Drive QC electronic analytical records implementation”
What You'll Achieve.
Ensure effective execution of works; Support QC related business; Ensure end-to-end compliance; Eliminate GMP and Data Integrity risks; Simplify and optimize processes; Improve Right-First-Time performance; Provide timely and accurate analytical results; Ensure analytical processes remain controlled; Ensure laboratory remains compliant
Industry & Context.
QbD thinking
What They're Looking For.
Must Have
Bachelor of Science Degree or above, Pharmacy, Chemistry, Biochemistry, microbiology and equivalent, At least 4 years of relevant experience in laboratory analysis and/or QC digital deployment etc. , within a pharmaceutical company.
What You'll Do.
Execute digital system deployment
Drive QC electronic analytical records implementation
Ensure global digital systems compliance
Eliminate GMP and Data Integrity risks
Simplify and optimize processes
Improve Right-First-Time performance
Manage Roche global digital systems
Inspect and examine samples
Provide analytical results and reports
Support trend analysis
Execute laboratory investigations
Support laboratory investigations
Manage daily sample management
Manage reference standard management
Manage stability sample management
Assist laboratory GMP self-inspections
Track improvement plans implementation
Manage instrument/equipment lifecycle
Execute instrument/equipment business operations
Complete assigned tasks
How You'll Work.
Team & Collaboration
Work with product team
Communication Scope
English – Good Listen/Speak capabilities
Process & Methodology
Project management approach, Project Management skills
Full 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 **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, excipie
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