Pharmacien(ne) de libération/ Qualified Person
Core
Qualified Person responsible for raw material acceptance, product release certification, and quality compliance for injectable biologics in clinical trials.
Role type
Senior Qualified Person (Pharmacist)
Builds
Injectable biologics for clinical trials (vials, syringes, cartridges)
Domain
Pharmaceutical manufacturing / Biologics / Clinical trials
Required skills
GMP compliance, deviation management, CAPA, process validation, sterile environment handling, regulatory knowledge, quality investigations, data analysis
Preferred skills
Sterile manufacturing experience, chemistry/physics/microbiology knowledge, client relations
Technologies
GMP systems, validation tools, quality management software
Responsibilities
Validate and track raw materials, certify and release manufactured batches, manage deviations and CAPAs, support audits and client inquiries, approve major quality documents
Seniority
Senior, hands-on IC
