Jobdescription
We are looking for an Aseptic Operations Expert for a one-year mission to revamp one of our aseptic filling lines.
As an Aseptic Operations Expert, you will ensure the highest standards of Sterility Assurance and Contamination Control during this one-year mission focused on the revamping of our filling line (Line 6) in the Fill & Finish (FDF) department. Your expertise will help ensure compliance with Annex 1 and other relevant GMP requirements, contributing to the safety and efficacy of our products.
Key Responsibilities:
* Redesign Aseptic Practices and Risk Assessment: Evaluate and redesign current aseptic practices based on the filling machine upgrade (Barrier System and RABS implementation). Conduct a comprehensive risk analysis of the redesigned operations and define necessary risk mitigation actions.
* APS Strategy and Airflow Studies: Collaborate on the initial validation strategy for Aseptic Process Simulation (APS) on the upgraded filling line, ensuring oversight and preparing key operational documentation. Organize airflow visualization studies (AVS or "smoke tests") to qualify new aseptic practices and supervise these critical activities.
* Training and Compliance: Lead training sessions on good aseptic practices, fostering a culture of excellence and compliance.
* Deviation Management and Project Follow-Up: Assist in managing deviations, CAPA, and Change Control, ensuring thorough investigations and timely resolutions. Participate in follow-up sessions with the Project Team and provide updates on Aseptic Operations activities.
Who You Are:
* Degree in Biotechnology or equivalent
* Strong knowledge of the pharmaceutical environment, particularly aseptic filling processes (3-6 years of experience)
* In-depth knowledge of Good Manufacturing Practices (BPF/GMP), especially Annex 1 EU GMP
* Excellent writing skills (Procedures, Risk Analyses, Deviations, etc.)
* Team player with leadership, autonomy, proactivity, and good communication skills
* Native French speaker, fluent in English (minimum B2)