Responsable Assurance Qualité H/F
Core
Quality Assurance role supporting controlled manufacturing activities and regulatory compliance.
Role type
Quality Assurance Specialist (Pharmaceutical/Regulated Industry)
Builds
Quality management systems, audit reports, regulatory compliance documentation
Domain
Pharmaceutical industry, Quality Assurance, Regulatory Compliance
Required skills
GMP knowledge, regulatory monitoring, supplier evaluation, internal/external audit management, CAPA management, change control, analytical chemistry or microbiology knowledge
Preferred skills
Continuous improvement project management, training and awareness, equipment qualification protocols
Technologies
GMP, Ph. Eur., USP, JP, ICH guidelines
Responsibilities
Manage client audits, monitor regulatory updates, train staff on GMP, evaluate suppliers, participate in internal/external audits, review lab documentation, sign analysis certificates, approve quality records and validation protocols, lead continuous improvement projects
Seniority
Mid-Senior, hands-on IC