Management of operational QA aspects within the daily collaboration with CMOs during CMC development and GMP manufacturing of early and late stage projects in close coordination with the QA and Supply Chain departments, including:
Review and authorization of batch records;
Change control procedures and deviations;
Validation plans and reports.
Preparation of product specification files;
Handling of temperature deviations during transport;
Preparation of batch release packages;
Support compilation of SOP environment from CMC perspective;
Support establishment of quality agreements with contract manufacturers.
Degree in natural sciences combined with relevant industry experience in a GMP/QA environment for biotechnological products;
Proven experience with operational QA procedures in the CMC field;
Sound knowledge of the pharmaceutical laws, regulatory guidelines and GMP requirements for late stage CMC development;
Deep understanding of pharmaceutical production and analytical testing of biotechnological products;
Excellent command of English and German both written and spoken;
Excellent communication and management skills;
Well organized and able to handle multi-tasking situations under time constraints.