Expert qualité MTI - CDI - H/F
Core
Ensure quality and compliance of innovative therapy drugs (MTI) manufactured in-house or outsourced, managing third-party quality processes and crisis management.
Role type
Senior Quality Expert (Pharmacist)
Builds
Innovative therapy drugs (MTI) and sterile medications
Domain
Pharmaceutical industry, sterile manufacturing, quality assurance
Required skills
Sterile drug manufacturing processes, Quality Assurance/Quality Control, Regulatory compliance, CAPA management, Supplier qualification, Internal/External audit coordination, Crisis management, Documentation management
Preferred skills
Knowledge of MTI drugs, English (fluent oral and written)
Technologies
QAGR, GMP
Responsibilities
Pilot third-party quality processes for MTI production, coordinate internal and external audits, manage non-conformities and CAPAs, lead crisis management involving third parties, participate in supplier selection and qualification, update quality documentation.
Seniority
Senior, hands-on IC
