We are looking for a QA Batch Review Specialist (m/f/d) for Lonza AG (100%). This is a temporary position until the end of 2022.
Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there's no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, they let their people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work Lonza wants to be part of.
Review of the Executed Batch Records (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.
Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager.
Support the initiation of deviations and investigations for Batch Record review related observations.
Collect and evaluate on a regular basis KPI data.
Write and revise SOPs in his/her area of expertise.
Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field.
Previous experience in GMP regulated pharmaceutical / API industry is an advantage.
Ability to identify non-compliance and gaps from quality standards.
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
English: very good command; German is advantage