Job Description
We are seeking 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 mission, focusing 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:
1. Redesign Aseptic Practices and Conduct Risk Assessments: Evaluate and redesign current aseptic practices based on the filling machine upgrade (Barrier System and RABS implementation). Conduct comprehensive risk analyses and define necessary risk mitigation actions.
2. Develop APS Strategy and Conduct Airflow Studies: Collaborate on the validation strategy for Aseptic Process Simulation (APS) on the upgraded line, oversee and prepare operational documentation, and organize airflow visualization studies (AVS or "smoke tests") to qualify new aseptic practices.
3. Training and Compliance: Lead training sessions on good aseptic practices to foster a culture of excellence and compliance.
4. 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 (GMP), especially Annex 1 EU GMP.
* Excellent writing skills (Procedures, Risk Analyses, Deviations, etc.).
* Team player with leadership qualities, autonomy, proactivity, and good communication skills.
* Native French speaker, fluent in English (minimum B2).
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