Our client, a leading pharmaceutical organization, is seeking a Sterility Assurance Manager. This role focuses on developing and overseeing the sterility assurance program to maintain safety and regulatory compliance in vaccine production. The position serves as a technical expert in microbiology and aseptic processes to drive continuous improvement across manufacturing units.
Responsibilities
* Develop and maintain a comprehensive sterility assurance roadmap, including ownership of the Contamination Control Strategy.
* Monitor manufacturing processes to identify contamination sources and implement necessary corrective and preventive actions.
* Interpret microbiological data and trends to provide holistic recommendations for process improvements.
* Perform facility design assessments and oversee risk assessments for environmental monitoring and aseptic processes.
* Drive compliance with GMP and QMS requirements through regular gap analyses and performance monitoring.
* Act as a technical expert during regulatory inspections, corporate audits, and internal reviews.
Qualifications
* Bachelor’s or Master’s degree in Pharmacy, Biology, Biochemical Engineering, or a related scientific field.
* You bring 5+ years of professional experience in a pharmaceutical manufacturing environment focused on sterile drugs or vaccines.
* You have extensive knowledge of sterility assurance including Contamination Control Strategy, aseptic processes, environmental monitoring, and bioburden/endotoxin risk assessments.
* You possess strong expertise in quality and compliance such as cGMP, QMS, and root cause analysis.
* You're a proactive problem-solver with strong communication and influencing skills.
* You are fluent in French and English.
Nice to Haves
* Knowledge of Lean Six Sigma methodologies or Green Belt certification.
* Experience in training and mentoring staff on aseptic techniques.
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