QA Ops Specialist 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 Planet Performance People Responsible Sourcing Global Quality 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 Planet Performance People Responsible Sourcing Global Quality 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 Ops Specialist 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. In Visp we are looking for a Batch Record Reviewer to extend our team. You will report to the QA Operations Group Leader, work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within QA Key responsibilities Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations Ensure shop floor QA oversight is a must ( 20%) Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs. Author, Review and approve GMP-relevant documents and SOPs Responsible to present Drug Product QA Operations or support with other SMEs topics during the conduction of all customer audits, internal audits and regulatory inspections within DPS Visp / Biologics / Visp site. Provide GXP-related trainings to Module D Operations personnel (eg. GMP, Good Documentation Practice,…) Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments Review and release product specific documentation such as process descriptions, recipes, manufacturing batch records, etc. Review and approve executed batch records , prepare batch release for the responsible person (FvP), including recommendation on disposition status Support continuous improvement programs to establish an effective Quality Management System for DPS Visp Interact with customers for QA operations topics such as SOPs, change controls, deviations, complaints and others Key requirements Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field Previous experience in GMP regulated pharmaceutical / API industry is an advantage Ability to identify non-compliance and gaps from quality standards Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive Full proficiency in English is a must, German or additional languages are a plus  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. 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