- responsible for planning, coordination and implementation of changes according to GMP guidelines (Matrix-Lead)- responsible for creation and modification of master manufacturing documention- training and support of master manufacturing documentation for the production employees- continuous improvement and standardisation of the change process- presentation of the changes at audits- moderation of meetings- incorporating new colleagues

- conceptual design of validation projects- responsible for creating validation plans, reports and master documents written in German (plans) and English (reports and master documents)- training and support of validation activities for the production employees- preparation, analysis and presentation of validation data- processing of governmental inquiries regarding process validation

- processing of changes/deviations according to GMP guidelines- manufacturing preparation according to GMP guidelines- preparation of master manufacturing reports for release by quality department- analysis, preparation and presentation of process data- implementation of new products in cooperation with development- data comparison of FDA approved documents with the master manufacturing report in cooperation with regulatory affairs- implementation of researches and… Show more - processing of changes/deviations according to GMP guidelines- manufacturing preparation according to GMP guidelines- preparation of master manufacturing reports for release by quality department- analysis, preparation and presentation of process data- implementation of new products in cooperation with development- data comparison of FDA approved documents with the master manufacturing report in cooperation with regulatory affairs- implementation of researches and evaluations for preparation of QRM-report (Quality Risk Management) and risk analysis- integrating new colleagues Show less

second practical semester, area: GVC/E - Joint Innovation Lab - Organic Electronics (JIL)