Overview In this role you lead the Contamination Control Strategy (CCS) and drive a strong sterility assurance culture at the Visp site. You partner with Operations, QA, QC, and global teams to ensure regulatory compliance, operational excellence and continuous improvement in contamination control and aseptic processing. You act as the SME for facility design, tech transfers and risk assessments, guiding investigations and CAPAs. You will engage in inspections and audits, shaping sterile manufacturing for a broad portfolio. Verantwortungsbereiche Own and improve the Contamination Control Strategy (CCS) to maintain regulatory compliance and industry best practices Provide technical leadership for aseptic processing, APS, sterilization, cleanroom management, and contamination control programs Serve as Sterility Assurance SME for facility design, technology transfers, and contamination risk assessments Lead investigations, corrective and preventive actions, and root cause analyses related to sterility Manage environmental monitoring strategies, metrics, trend analysis and improvement initiatives Represent Sterility Assurance in health authority inspections, customer audits, and cross-functional forums Zentrale Anforderungen Academic degree in a scientific discipline Extensive experience in microbial control and sterility assurance in pharma Hands-on expertise in contamination control, aseptic processing, APS, environmental monitoring and microbiological investigations Deep knowledge of cleanroom engineering, sterilization, microbiological testing and risk management Strong communication, decision making, conflict resolution and change management in complex operations Solid understanding of GMP and pharmaceutical regulations, including USP/EP, bioburden, endotoxin, sterility testing communication decision making conflict resolution aseptic processing APS (Aseptic Process Simulation) environmental monitoring
QA Sterility Assurance Lead (SAL) - Drug Product 80-100% (f/m/d) Arbeitgeber: Lonza
Lonza ist ein hervorragender Arbeitgeber, der eine dynamische Arbeitskultur und flexible Arbeitsmöglichkeiten bietet, um die besten Talente zu fördern. Mit einem starken Fokus auf persönliche Entwicklung und Teamarbeit ermöglicht Lonza seinen Mitarbeitern, ihre Karriere in einem bedeutenden Bereich wie der internen Revision voranzutreiben, während sie gleichzeitig zur Verbesserung von Millionen von Leben beitragen. Die enge Zusammenarbeit vor Ort fördert nicht nur den Austausch von Ideen, sondern auch die technische Präzision, die für die Herstellung von Arzneimitteln erforderlich ist.
