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.** T**his is a FIX TERM POSITION for 1 year** We are always keen to keep skilled people within our organization, there might a possibility to extend the fix term contract.

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
- Full working proficiency in German and conversational English language skills
- 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

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.