Lonza
QA Specialist, Batch Record Review 80-100% (f/m/d)
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 Visp we are looking for a QA Specialist (f/m/d) to extend our team. You will be part of the QA Operations Group Bioconjugates and work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation.
What you’ll get:
An agile dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependent on role and location
Relocation assistance for eligible candidates and their families
What you'll do:
Review and approval of the master electronic batch recipes and the executed electronic batch records in MES Syncade (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
Support batch release by ensuring the completeness of the documentation package
Involvement in MES Syncade Recipe change management
Collaborate with Operations team to clarify ambiguities in the executed batch records
Support in the management of Quality Records (Change Request, CAPAs, Deviations/Investigations) for Batch Record review related observations
Collect and evaluate on a regular basis KPI data
Support continuous improvement activities
Write and revise SOPs in area of expertise if required
What we are looking for:
University Degree in Life Sciences e.g. Chemistry / Biotechnology or any other related field
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
Experience with TrackWise, SAP, Syncade and Microsoft suite of products is preferred
Experience collaborating closely with different functions and departments
Meticulous and systematic, team player, with strong focus on safety, quality and timelines
Fluency in English language (written and spoken)required and intermediate German language skills are 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.