Responsable Assurance Qualité Opérationnelle F/H
Core
Ensure on-site application of current rules and standards (GMP, Pharmacopoeia, ISO norms) to enable safe market launch of pharmaceutical products.
Role type
Operational Quality Assurance Specialist
Builds
Pharmaceutical products (hospital preparations, specialities, medical devices)
Domain
Pharmaceutical industry / Quality Assurance
Required skills
GMP, Pharmacopoeia, documentation review, CAPA management, Change Control, root cause analysis, regulatory audits, training delivery
Preferred skills
Medical devices knowledge, 5M/AMDEC/ICH methods
Technologies
GMP, CAPA, Change Control, 5M, AMDEC, ICH
Responsibilities
Review batch documentation and ensure process compliance; Lead investigations for non-conformities, deviations, and OOS/OOT results; Manage Change Control and CAPA actions; Conduct or coordinate internal and supplier audits; Train operational teams on GMP application.
