Roman Halbeisen

Quality assurance and validation support of projects, e.g. aseptic bio technology product transfer.

Supervising of internal and external employer. Responsible for the concepts, planning and control of validation and qualification, incl. risk management. Coordination of projects and studies. Support of audits.

Preparation of validation concepts, master files, risk assessments, SOPs, qualification- und validation documents. Supervising of project teams. Assessment of change requests, deviation and CAPAs. Support of audits.

Coordination of the product and technology transfer from the development site to the commercial manufacturing site. Preparation of the GMP-documentation (CR, master file, risk assessment, master batch record, SOPs, process- and cleaning validation).

Supervising of the laboratory team and management of the in process control tests. Training of new operators. Support for external contract manufacturer. Maintenance of the laboratory test devices. Statistical control of process data. Support for development and launch products, validation, deviation and complaints from consumer.

Synthesizing of natural biological active substances.

Development of synthesis method for the commercial production.