Qualified Person (QP)

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.

The role:

The duties of a Qualified Person (QP) in accordance with Directive 2001/83/EC (as amended by Directive 2017/1569) and Regulation 536/2014, specifically overseeing the confirmation of Drug Substance and Drug Substance Intermediates.

At Lonza, you will be responsible for reviewing manufacturing and testing documentation, supporting QA leadership in the daily management of the Pharmaceutical Quality System (PQS), and ensuring compliance throughout the product lifecycle. The position also provides quality guidance to promote continuous improvement and maintain a robust, fit-for-purpose PQS.

Registered Qualified Person issued by RSC / RBS/ RPS is essential

Responsibilities

• Ensure manufacturing, testing, and shipping activities comply with cGxPs, SOPs, regulatory, health & safety, and environmental requirements.

• Review batch documentation, environmental data, investigations, change controls, SOPs, qualification reports, and GMP compliance.

• Confirm batch release in line with manufacturing and shipping schedules and regulatory standards.

• Assess and guide resolution of quality issues across departments.

• Drive continuous improvement initiatives and process optimization.

• Maintain QP eligibility on MIA and MIA(IMP) licenses.

• Manage deviations and ensure compliant, timely CAPA closure.

• Represent QP disposition process in internal meetings and cross-functional forums.

• Support regulatory inspections and customer audits.

• Respond proactively to customer queries and support cross-functional collaboration.

Requirements:

• BSc in science or QA discipline is highly desirable

• Registered Qualified Person issued by RSC / RBS/ RPS is essential

• Excellent knowledge and ability to interpret and translate EU and US GMP regulations and

• guidelines

• Excellent communication skills (verbal and written)

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.