Regional Environmental Monitoring Expert
Core
Ensuring environmental controls of viable and non-viable particles in qualified cleanroom areas to support the manufacturing of high-quality drugs and vaccines.
Role type
Senior IC Quality Specialist (Environmental Monitoring)
Builds
Environmental monitoring reports and data trends for manufacturing facilities
Domain
Life Sciences / Pharmaceutical Manufacturing / GxP Compliance
Deliverable
dashboards & analysis
Required skills
Microbiology, Data interpretation, Root cause analysis, Regulatory compliance (GMP/GxP), Report writing, Stakeholder management, Continuous improvement
Preferred skills
Stability management, QV experience, Digitalization of processes
Technologies
CMS (Content Management System), QMS (Quality Management System)
Responsibilities
Analyze and trend microbiological data, interpret EM results, document and investigate deviations, support audits and inspections, manage QMS records, drive process standardization
Seniority
Senior, hands-on IC