M&S - Quality Expert Method Digitalization IFB 质量方法数字化专家 IFB
Core
Coordinate the digitalization and harmonization of analytical methods and the implementation of the Lab Execution System (LES) for new insulin manufacturing sites in Germany and China.
Role type
Senior Quality Control Method Digitalization Expert (Project Lead & Key User)
Builds
Digital QC/MQC laboratory environment (LES) and harmonized analytical processes for new manufacturing sites
Domain
Pharmaceutical manufacturing / Quality Control / Digitalization
Required skills
GxP regulations, analytical method transfer, Lab Execution Systems (LES), project coordination, gap assessment, master data management, GMP documentation, SAP, LIMS
Preferred skills
Labware experience, LIMS roll-out experience, LEAN process optimization
Technologies
SAP, LIMS, OneLIMS, Labware, Word, Excel
Responsibilities
Coordinate interdisciplinary project teams for LES implementation; evaluate and optimize LES within QC labs; manage method digitalization and harmonization; conduct gap assessments against global templates; manage method transfers to new sites; create GMP-compliant documentation and SOPs; support training on digital processes.
Seniority
Senior, hands-on IC with project leadership
