Responsable Assurance de Stérilité
Core
Lead the sterility assurance function for a vaccine production site, managing contamination risk and ensuring product safety for patients.
Role type
Senior Sterility Assurance Manager (Pharmaceutical Manufacturing)
Builds
Sterile injectable vaccines
Domain
Biopharmaceuticals / Vaccine Manufacturing
Required skills
Sterility assurance, microbiology, cGMP compliance, risk assessment, team management, regulatory inspection, aseptic process validation
Preferred skills
Industrial microbiology expertise, cross-functional influence, data analysis
Technologies
cGMP, Annex 1, aseptic processing, environmental monitoring
Responsibilities
Lead a team of 18, define and evolve sterility strategy, evaluate contamination risks, approve microbiological investigations, support regulatory inspections, train teams on aseptic practices.
Seniority
Senior, hands-on IC with management responsibilities