QA Professional

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.

For our site in Cologne we are looking for an experienced Quality Professional who actively supports the group in various quality processes, compliance and continuous improvements of the quality management system (GMP, ISO 9001). Our customers work in the field of Cell and Gene Therapy. The manufacturing and testing of our products take place internally and with external partners and requires good communication with the various parties. The position as QA Professional offers exciting insights and interactions with the involved departments such as QC, Production and R&D.

Key responsibilities:

· Support and handle QA processes including quality impact assessment for deviations, change control, CAPA and customer complaints.

· Perform document review of SOPs, batch records, validations, qualifications, stability studies.

· Participate in GMP investigations and root cause analysis for QC and manufacturing.

· Monitoring and follow-up with involved departments for completion of deviation-investigation, change control and CAPA

· Prepare and provide training for QMS / GMP topics

· Prepare and participate in audits

Key requirements:

• Hands on experience with GMP quality processes and general knowledge of GMP manufacturing and GMP QC processes

• Knowledge and good understanding of ISO 9001, ISO 13485 standards

• Knowledge of TrackWise, Cornerstone, Documentum, SAP is beneficial

• Good communication skills to represent quality aspects in cross-functional project teams

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.