Beschreibung

You manage the Sterility Assurance Program, ensuring compliance and quality in aseptic processes. Your responsibilities include conducting risk assessments, training, and mentoring staff to uphold high standards in contamination control.

Anforderungen

• •Bachelor’s or Master’s in Microbiology or related field
• •5+ years in GMP biologics or sterile manufacturing
• •Profound understanding of aseptic processing
• •Strong experience with investigations and CAPA
• •Excellent communication and decision-making skills
• •Proficiency in maintaining sterility standards
• •Detailed problem solving and risk-based thinking
• •Continuous improvement approach

Aufgaben

• •Lead the Sterility Assurance Program and Contamination Control Strategy.
• •Conduct risk assessments for aseptic processes and critical interventions.
• •Establish and track sterility assurance benchmarks and performance.
• •Coordinate QA for aseptic processing of drug substances and products.
• •Perform routine Gemba/walkthroughs and provide on-floor QA support.
• •Oversee environmental monitoring program planning and execution.
• •Investigate EM excursions and drive CAPA efficiency.
• •Provide QA oversight for sterilization methods and schedules.
• •Approve sterilization cycle development and validation protocols.
• •Ensure validated cleaning and decontamination procedures are followed.
• •Evaluate and endorse SOPs and QA standards for aseptic operations.
• •Lead internal and external audits, ensuring readiness and remediation.
• •Manage deviations and root cause analyses for sterility issues.
• •Lead QA for changes impacting sterility in processes and materials.
• •Support tech transfers for new biomolecule products and processes.
• •Develop and present aseptic behavior training and gowning certifications.
• •Mentor staff to reinforce contamination control culture.