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

Today, Lonza is a global leader in life sciences operating across five 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.

What you’ll get :

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

What you’ll do :

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) andreview (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 Organization, 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.

What we are looking for :

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.

Reference : R67939