Sterility Assurance

il y a 6 jours


France ProductLife Group Temps plein

Sterility Assurance & Aseptic Processes ExpertProductLife Group is looking for a Sterility Assurance & Aseptic Processes Expert (Injectables) to join our growing Team.Role / Mission:Lead sterility assurance strategy and CCS/APS implementation.Drafting of scientific justifications, protocols, reports, SOPs.Gap analysis vs. GMP Annex 1 & 13.Support for regulatory inspections and CCS documentation.Experience level: Confirmed (5–7 years) or Expert (10+ years).Technical skills:GMP Annex 1, sterile operations, aseptic filling under isolator.Strong regulatory knowledge (EMA, FDA).Soft skills: Rigorous, organized, autonomous, analytical, strong relationship skills.Practical aspects:Mobility across France ideally; flexibility possible in large industrial hubs.Languages: French and English mandatory.Contract: Permanent.Availability: to be discussed.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionHealth Care Provider in Pharmaceutical Manufacturing #J-18808-Ljbffr



  • France ProductLife Group Temps plein

    Sterility Assurance and Aseptic Processes ExpertPLG is a consulting firm specializing in life sciences. We support our clients in their regulatory, quality, and industrial projects, providing them with expertise, agility, and commitment.We are looking for: Sterility Assurance & Aseptic Processes Expert (Injectables)Role / MissionLead sterility assurance...