QA Documentation Coordinator 80-100% (f/m/d)

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• A variety of benefits dependant on role and location

• As QA Documentation Coordinator, you will coordinate the tasks related to manufacturing documentation readiness ( e.g readiness of Batch records and other associated records before production) and review ( e.g review executed batch records, forms, logbooks etc after production ) ; hybrid paper/electronic documentation system

• As QA Documentation Coordinator, you will be the preferred point of contact for other departments within the Manufacturing Unit ( e.g QA, Operations) as well as outside of Lonza ( e.g external customers) for all topics related to documentation review

• As QA Documentation Coordinator, you will present the documentation review process in internal/external audits and inspections

• Typical daily activities include coordination and execution of review activities for manufacturing documents or quality records ( e.g Batch records, SOPs, risk assessments, deviations, change controls, documents needed for batch release…) in Lonza Quality Systems ( e.g Documentation Management System, Trackwise )

• As a Member of the Quality Organizati on, you will provide quality guidance on daily activities as well as unexpected situation to ensure business continuity and release of our products to our customer .

• University degree in Biotechnology or any related field

• Business fluent English is required, good German language skills - an advantage

• Solid experience in a GMP environment, incl in a Batch Record Reviewer role

• Good understanding of EU and FDA GMP regulations. Good quality mindset. Good knowledge of aseptic manufacturing regulations is a plus

• Agile skills in a challenging work environment and proactive mindset to improve processes

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 .