Senior Specialist, QA Operations
Core
Senior QA Operations SME ensuring GMP compliance, inspection readiness, and robust quality processes for routine manufacturing, projects, and NPIs at an oral solid dosage drug site.
Role type
Senior Specialist, QA Quality Operations (Manufacturing)
Builds
Compliant commercial and clinical drug products
Domain
Pharmaceutical manufacturing (Oral Solid Dosage)
Required skills
cGMP knowledge, deviation management, CAPA implementation, change control, validation oversight, risk assessment, batch record review, regulatory inspection readiness, ERP/MES data management
Preferred skills
Operational Excellence, digitalization, Lean principles, Oral Solid Dosage (OSD) manufacturing knowledge
Technologies
ERP, MES
Responsibilities
Provide expert support for routine GMP oversight and deviation management; Act as SME for quality in projects and NPIs including validation studies; Drive continuous improvement and risk-based thinking; Ensure EHS compliance; Support QC activities and supplier quality
Seniority
Senior, hands-on IC
