Beschreibung

In this role, you will be at the forefront of ensuring sterility and contamination control in aseptic manufacturing. Your day-to-day responsibilities will involve developing strategies, leading risk assessments, and mentoring staff to uphold best practices in a dynamic environment.

Anforderungen

• •Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or related scientific field
• •Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
• •Strong background in sterility assurance or quality management within GMP-regulated environments
• •Demonstrated experience in investigations, CAPA, risk management, and audit interactions
• •Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
• •Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
• •Full professional proficiency in English; basic German is an advantage
• •Proactive problem-solver with strong communication skills

Aufgaben

• •Develop and maintain sterility assurance strategies
• •Establish contamination control strategies for aseptic processing
• •Lead risk assessments for aseptic processes and critical interventions
• •Ensure compliance with relevant authorities' guidance
• •Manage deviations and conduct root cause analyses for sterility issues
• •Implement CAPA and efficiency checks for bioburden and endotoxin
• •Provide training on aseptic and sterility best practices
• •Mentor operations and QA staff to promote contamination control culture
• •Stay updated on regulatory developments and revise procedures as needed