QA Project Manager, Senior QA Specialist (f/m/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 Project Manager, Senior QA Specialist (f/m/d) Switzerland, Visp 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. As a member of the QA Operations Team, the QA Project Manager, Senior QA Specialist (f/m/d) supports in all matters of GMP compliance (e.g. representation in local and global Quality Boards, contact person for customers and compliance questions), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area. Key responsibilities: Representing the department Quality Assurance in cross-functional teams and ensuring and managing interfaces to different internal and external stakeholder Assesses, reviews and approves quality records such as deviations, change controls, CAPAs, investigations, effectiveness checks, and extensions in line with valid SOPs Authors, reviews and approves GMP-relevant documents and SOPs in the ownership of QA Supports and participates in internal, customer and regulatory audits Support customer communications, manage interactions in case of changes, deviations, out of specifications etc. Review and approval of executed batch records, prepares batch release package for the Responsible Person / FvP, including recommendation on disposition status Review and approval Master Batch Records Support continuous improvements programs to establish effective Quality Management Systems Key requirements: Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field) Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11) Availability to occasionally provide quality support outside of working hours English language skills (written and spoken) are required, German is an advantage 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. The satisfaction that comes with making a meaningful difference. Reference: R59458 Apply Similar Jobs R58492 R58504 R58596 R58676 R59112 R59288 R59820 R59961 R60199 Ways to Contact Contact Us Regulatory Support Locations Site Tours Partnering with Us Resources Knowledge Center Meet the Experts Upcoming Events Terms & Conditions Terms and Conditions Legal Disclaimer Privacy Policy California CCPA Notice Transparency in Coverage Lonza.com Company Overview News & Media Investor Relations Sustainability Careers © 2024 Lonza. All rights reserved. Cookie Settings