Qualified Person (Médicament d'innovation thérapeutique)
Core
Responsible for raw material acceptance, product confirmation, and batch certification for injectable biologics in clinical trials and fill/finish operations.
Role type
Qualified Person (Pharmacist) for innovative therapeutic drugs
Builds
Injectable biologics for clinical trials and commercial fill/finish
Domain
Pharmaceutical manufacturing (biologics, sterile environment)
Required skills
Quality control, deviation management, regulatory compliance, project management, sterile environment experience, chemistry, physics, microbiology, biology, GMP knowledge, root cause analysis, action planning
Preferred skills
Innovative therapeutic drug experience, sterile environment experience
Technologies
GMP, QMS, LIMS
Responsibilities
Validate and manage raw materials, manage deviations, handle client relations regarding quality deviations, confirm and certify client batches, support audits related to deviations and clients
Seniority
Mid-level, hands-on IC
