QC Lab Systems Specialist
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.
Help establish DP analytical infrastructure and services for biologics, small molecule and peptide parenteral products for clinical and commercial products
Develop and write IQ/OQ and PQ documents, standard operations procedures (SOPs), validation plans/ reports and other qualification relevant documentation
Install, qualify and maintain instruments for DP Physico-Chemical QC in close alignment with current best practices and regulations
Review and approve laboratory systems related reports as required following applicable SOPs and all current documentation practices
Ensure compliance of laboratory systems according to cGMP, following applicable SOPs, current best practices and international guidelines as well as current documentation practices
Act as subject matter expert for laboratory system qualification within audits and inspections
Ensure proper maintenance of equipment, safety and health protection following lab and safety instructions and all cGMP regulations
A degree in e.g. Analytical Chemistry, Biochemistry, Pharmaceutical Sciences
Some experience in qualification and/ or validation on analytical instruments and associated applications in pharmaceutical industry
Applied knowledge of the regulatory requirements (21CFR Part 11, GAMP 5 etc.)
Good working knowledge in analytical techniques and equipment relevant for the analytics of proteins and parental dosage forms
Good interpretation and documentation of results and excellent understanding of GMP-compliant documentation
Excellent knowledge of written and spoken English
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.