Biologe (m/w/d)
Core
Senior expert for qualification activities within Quality Control (QC) labs, supporting system, process, and service qualification.
Role type
Senior IC QC Services Expert
Builds
Qualified laboratory equipment and systems for pharmaceutical manufacturing
Domain
Pharmaceutical industry + Quality Control / GxP
Required skills
Laboratory equipment qualification, GxP compliance, Computer System Validation (CSV), project management, documentation review, CAPA handling, process standardization, training delivery
Preferred skills
Empower, SAP, LIMS, SampleManager, ELN/ELS, Tiamo
Technologies
Empower, SAP, LIMS, SampleManager, ELN/ELS, Tiamo
Responsibilities
Act as technical contact for QC qualifications, support QC labs in equipment/system qualification, plan and coordinate qualification activities, review and approve qualification documents, develop and harmonize qualification processes, create and update SOPs, conduct training, handle deviations and CAPAs
Seniority
Senior, hands-on IC