Sterility Assurance and Aseptic Processes Expert

il y a 1 jour


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 strategy and CCS/APS implementation.Risk analyses (initiation, execution, CAPA follow-up).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 SkillsGMP Annex 1, sterile operations, aseptic filling under isolator.Risk management (AMDEC, deviation, change control).Strong regulatory knowledge (EMA, FDA).Soft skills: Rigorous, organized, autonomous, analytical, strong relationship skills.Practical AspectsMobility across France is ideal; flexibility is possible in large industrial hubs.Languages: French and English are mandatory.PLG is an equal opportunities employer and welcomes applications from diverse candidates. #J-18808-Ljbffr


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