Quality Unit Business Process Specialist - Drug Substance
Core
Oversee quality systems and business processes for drug substance manufacturing, ensuring regulatory compliance and driving continuous improvement.
Role type
Quality Unit Business Process Specialist
Builds
Quality systems, SOPs, and compliant manufacturing processes for drug substances
Domain
Pharmaceutical manufacturing (Drug Substance)
Required skills
cGMP, GxP Regulations, Root Cause Analysis, CAPA, Change Control, Risk Assessment, Technical Writing, Data Integrity, Lean Management, SAP/ERP
Preferred skills
LIMS, MES, eBatch Records, Inspection Readiness, Coaching/Mentoring, KPI Monitoring
Technologies
SAP, LIMS, MES, eBatch Records
Responsibilities
Provide quality oversight for drug substance processes; Support investigations and root cause analysis; Facilitate quality impact assessments and risk reviews; Develop and maintain SOPs; Train and coach colleagues on quality processes.
Seniority
Mid-level, hands-on IC
