Roman Halbeisen
Inhaber, Owner / Consultant, Roman Halbeisen Consulting Service
Menzingen, Schweiz
Werdegang
Berufserfahrung von Roman Halbeisen
Bis heute 8 Jahre und 6 Monate, seit Jan. 2016
Owner / Consultant
Roman Halbeisen Consulting Service
Quality assurance and validation support of projects, e.g. aseptic bio technology product transfer.
2013 - 2015
Teamleader Validation
Legacy Pharmaceuticals Switzerland GmbH
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.
2008 - 2013
Validation Expert
Legacy Pharmaceuticals Switzerland GmbH
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.
2000 - 2008
Validation Specialist
Novartis Pharma AG
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).
1995 - 2000
Dep. Head Inprocess Control Laboratory
Novartis Pharma AG
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.
1994 - 1995
Chemielaborant
Ciba
Synthesizing of natural biological active substances.
Development of synthesis method for the commercial production.