Aseptic expert

Job description

• Define and implement the Aseptic Process Simulation (APS) strategy across aseptic production lines in to sites of Gedeon Richter. On-the-floor oversight and organization of each APS has to be ensured adhering strictly to GMP rules and procedures. Develop key operational documentation for APS activities, including risk assessments, protocols, reports and annual plans are needed to ensure clarity and compliance
• Collaborate in the organization of airflow visualization studies (AVS or "smoke tests"). You will define strategies, elaborate operational documentation, and supervise these critical activities on-the-floor
• Drive initiatives to enhance aseptic practices and minimize contamination risks across the Finished Product Manufacturing Plants as part of Contamination Control Strategy (CCS). Propose proactive measures aimed at achieving these objectives
• Develop and lead training sessions on good aseptic practices and aseptic behavior for involved personnel, fostering a culture of excellence and compliance within the aseptic core
• Monitor the aseptic behavior of production operators, ensuring that all aseptic operations are carried out to the highest quality standards
• Contribute to the management of deviations, CAPA, and Change Control within the scope of activity, ensuring thorough investigation and timely resolution
• Represent as SME during regulatory audits and inspections, showcasing our commitment to compliance and quality
• Participate in evaluating compliance with current regulatory requirements (Annex 1 EU GMP, FDA Guidelines, etc.) and future updates. Assess any gaps and guide the implementation of best practices to ensure ongoing compliance

Expectations

• Education in biotechnology, microbology, pharmacy or equivalent
• Mastery of the pharmaceutical environment and in particular of aseptic filling processes and aseptic practices (3-6 years experience)
• Knowledge of Good Manufacturing Practices (BPF / GMP), in depth knowledge of Annex 1 EU GMP
• Skills: proactivity, and good communication are qualities necessary for success
• Language skills: Fluency in English required to understand international regulations and communicate with foreign partners

We offer

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance