ARTO
- Creation and ongoing maintenance of the plant technical requirements as system owner for the fulfilment of operational and legal requirements, together with the radiation protection and occupational safety department, as well as with quality assurance on the part of GMP requirements
- Taking the necessary measures and precautions to ensure trouble-free operation, involving the technical maintenance teams
- Analysis of the causes of technical faults, if necessary in cooperation with external service providers, with the technical teams and across departments, as well as implementation of immediate solutions and preventive strategies
- Enabling minimal downtime when carrying out repairs and maintenance work in coordination with production
- Planning of extensions or modifications to existing systems, including acceptance and qualification
- Contribution of expertise to new construction projects, especially in the formulation of requirements and design testing regarding maintainability and robustness of the systems, taking into account clean room classes and radioactive environments
- Provision of the necessary technical and GMP-relevant documents
- Establishing and ensuring the professional documentation of maintenance and repair work as evidence for technical measures, for commercial issues and for internal and external audits
- Creating and implementing changes for all GMP-relevant measures, as well as corrective and preventive actions, creating and processing deviations, conducting investigations
- Assisting customers and authorities with audits and inspections
