QA Expert / Senior QA Specialist Instrument Qualification, Drug Product Services (m/f/d) Our Offering Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Our Company About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Careers Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Contact Our Offering Corporate Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Back Our Company Corporate About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Back Careers Corporate Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Back Contact Corporate Back QA Expert / Senior QA Specialist Instrument Qualification, Drug Product Services (m/f/d) Switzerland, Basel Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. 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. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For Drug Product Services (DPS) , our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland , we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position Senior QA Expert/Specialist Instrument Qualification (m/f/d). Key responsibilities: Ensure that all lab instruments at DPS are in compliance with Lonza procedures and governmental regulations Act as the QA point-of-contact for our stakeholders at Lonza DPS Review and approval of lab instrument related quality records (e.g. Change control, CAPA, Deviation) and controlled documents (e.g. SOPs, Qualification Documents, Forms) at DPS Ensure adherence to lab instruments related DPS GMP procedures, Lonza Global and Group procedures, governing regulations and industry guidelines Provide strategic direction and guidance for lab instrument lifecycle management processes in line with GMP and LEAN principles Support and guide a team of QA experts Track, follow-up, trending and reporting on the GMP status of quality records, service providers and lab instruments Provide support and guidance to other groups at Lonza when needed (e.g. projects, audit-support, service agreements) Key requirements: Bachelor / Master Degree in natural sciences (e.g. Chemistry, Engineer, natural science or related field.) Significant experience with (computerized) lab instrument qualification, quality records and controlled document life cycle management, working in a EU and US GMP regulated environment Familiarity with ISPE GAMP5 Guide and USP 1058 required Experience in the usage of LIMS, DMS, Trackwise, SAP, ELN Excellent knowledge of written and spoken English Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, 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. In return, we offer the satisfaction that comes with improving lives all around the world. 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