- Leading the local QA team- Annual Product Reviews- Leading customer and health authority audits- Investigation lead for major deviations- QA contact for E2E supply chain

- QA responsible for Drug Product manufacturing and E2E Supply Chain- Investigation Lead for Major Deviations- Leading Health Authority and Customer Audits- Review of Product Quality Reviews

- Lead the Team for final product release- Lead the Team for Non-Conformance Investigations, CAPAs and Change Management

- Lead the SAP Implementation for Alcon Schaffhausen Site (SCM, QC, FIN, MFG)- Implementation of Manufacturing Execution System based on SAP - Single Point of contact and close cooperation with external consultants and global project team

- Managing external tech transfer into Drug Product manufacturing area (Clinical Phase 1 to commercial supply) and work in cross functional global teams- Evaluation of Request for Proposal (RfP) from external clients with regard to facility fit in Biopharma Fill&Finish Shanghai- Team Member in interdisciplinary transfer teams with international customers- Support production area/visual Inspection with respect to process optimization (quality, output, yield, compliance with international guidelines) and trouble shooting, incl. leading project teams for continuous process improvement- Development and implementation of new process technologies

- New Product Introduction- Support Qualification and Validation of DP filling process (media fill, microbial qualification of isolator, etc.)- Provide guidance during troubleshooting - Managing external tech transfer into DP manufacturing area (Clinical Phase 1 to commercial supply) and work in cross functional global teams- Sucessfully Ramped up GMP compliance DP sterile Filling Facility in regards of Aseptic Filling Process with Isolator technology and fully disposable, single use systems- Sucessfully Ramped up GMP compliance Visual Inspection (training, qualification of operators, inspection process, etc.)- Change Control Process- Continous improvement process in order to keep GMP compliance- Data Integrity SME- SME for root cause investigation and CAPA management

- Investigations- Technical Change Control- Support DP Transfer - Development studies- Filling systems- Supporting development projects- Supporting process validation- Implementation of new technologies, e.g. disposable filling assembly and peristaltic filling principle Cleanroom technology and monitoring with RABS- Well experienced in technical equipment, e.g. dry heat tunnel, vialwasher, time-pressure filler, lyophilizer, crimping machine as well as steam autoclaves, H2O2-air locks - Electronic Batch Record – MES (PAS-X)- Employee training and creation of SOPs- Design of Experiments (DoE)- Knowledge about GMP manufacturing for sterile products (cleaning, environmental behavior, mediafills and aseptic processing)

Examination of the contamination of surfaces and equipment by particles within aseptic production

- Term paper about efficiency of gas adsorption filter in semiconductor facilities regarding H2S, SO2 and DMSO- EU Projekt SPIRIT to prevent terroristic attacks on public infrastructure

filtration efficiency of ozone adsorption filter in air-handling systems