Senior QA Specialist (Ibex Solutions DD DS), Visp

Social network you want to login/join with: Senior QA Specialist (Ibex Solutions DD DS), Visp Client: Location: Job Category: Other Job Reference: b4848cde7daf Job Views: 10 Posted: 15.02.2025 Expiry Date: 01.04.2025 Job Description: Quality Operations Senior QA Specialist Today Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers and their ideas improve the world. The role: Join our team by applying for the position as QA Operations Senior QA Specialist (f/m/d). The Senior QA will be a member of QA Operations for Mammalian Small Scale (Single Use facility) Drug Substance manufacturing, managing quality oversight for contamination control and gap evaluation for internal/external audits/inspections. Key responsibilities: Key contact for Contamination Control Strategy (CCS) related topics for Single Use Mammalian Drug Substance Facility. Providing quality oversight regarding contamination prevention risks and controls. Leading CCS-related topics for the asset (Bioburden control strategy, hygiene, environmental monitoring). Review and approve deviation/investigation related to environmental monitoring excursions in the production area. Manage risk and quality oversight for CCS related topics. Participate in the Global Microbial Contamination Control Community to exchange information and best practices. Perform gap assessments for internal/external audits and inspections. Facilitate discussions within internal cross-functional teams (MSAT, Operations, QC, etc.). Review and approve the Standard Operating Procedure (SOP) of the relevant topic associated with the role. Involved in customer audits and regulatory inspections, ensuring inspection readiness of the department. Perform other duties as assigned. Key requirements: Bachelor\’s, Master\’s degree, or PhD in chemistry, biotechnology, life science, or related field. Sound years of experience in the GMP area within the pharmaceutical industry (preferably in the mammalian drug substance environment). Good knowledge of GMP and regulatory requirements. Strong leadership skills; very good communication skills and interaction with all kinds of interfaces within the organization. Structured, focused and well-organized working attitude; open-minded to new ideas, agile, highly motivated, and solution-oriented. Excellent knowledge of written and spoken English; good German skills advantageous. Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. #J-18808-Ljbffr