Specialist Compliance Excellence (m/f/d)
Core
Support operational compliance and quality system activities for GMP biologics manufacturing, focusing on investigations, documentation, change controls, and inspection readiness.
Role type
Specialist Compliance Excellence (P2)
Builds
GMP-compliant biologics drug substance for early-phase clinical supply
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation resolution, CAPA management, root cause analysis, change control, risk assessment, documentation management, audit support, performance monitoring, process improvement
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support resolution of GMP deviation records, investigations, and CAPAs; support GMP product-related change controls and risk records; provide compliance support for production-related questions and documentation; monitor and track quality and operational performance indicators; support inspection readiness and audit preparation; contribute to small projects and workstreams
Seniority
Junior/Mid-level, hands-on IC