Oorspronkelijke vacature omschrijving:

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 order to support our growth in Geleen (Netherlands), we are looking for a QA (Senior) Specialist Qualification to lead and support our project portfolio. The successful candidate will be joining a cross-functional, international team and reporting to a QA Qualification Team Leader. The main responsibilities are listed below, but not limited to and might be adapted depending on project priorities.

Key responsibilities:

• Owning all quality related responsibilities for the commissioning and qualification (C&Q) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing
• Representative of Quality in the CAPEX project organization in regard to qualification of facilities, utilities, equipment and systems
• Review and release of qualification documents and SOPs
• Being a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers

Key requirements:

• Master or PhD degree in Mechanical / Chemical / Pharmaceutical Engineering, Biotechnology, Life Sciences or other relevant disciplines
• Significant working experience in an cGMP regulated environment including experience with facility design, Commissioning, Qualification, Validation of equipment related to manufacturing processes
• Experience in management of different stakeholder
• Several years of experience working within an QA Department in the pharmaceutical industry
• Fluent in English required, Dutch 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.