QC IT Specialist Data Integrity DPS Growth Project 80-100% (m/f/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.
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Laboratory IT/OT/ Data integrity lead for a new sterile Drug product facility to support quality control and manufacturing related microbiology project activities.
Key responsibilities:
Ensuring timely implementation of adequate cGMP lab processes incl. rollout of a new LIMS system for the QC laboratory in frame of project ramp-up for commercial Drug Product testing.
Provide expertise for related laboratory business processes and contribute to global LIMS implementation project
Ensure compliance / data integrity status of laboratory systems and corresponding IT Infrastructure according to cGMP and current best practices and regulatory guidelines as well as respective SOP`s.
Authoring of cGMP documents e.g. procedures (SOPs) or source documents
Initiate, author and review quality records (Deviations, Change requests, Investigations etc.) as required
Participate as Subject Matter Expert in audits and inspections
Key requirements:
Academical degree or apprenticeship in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
Comprehensive working experience in pharmaceutical industries and cGMP controlled environment
Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon
Substantial experience on current compliance and data integrity standards corresponding to IT/OT systems used in laboratories
Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc. is a plus
Fluency in written and spoken English, German is an asset
Capability to work independently and in a dynamic & fast-pacing project environment
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.