Interim management in the areas of
- Management
- Quality management
- Head of production
- Business development
- Marketing & sales
Qualification/validation
- Qualification of premises
- Qualification of laboratory devices and production equipment
- Validation of processes in the areas of production/cleaning/laboratories
- Computer validation e.g. enterprise ressource planning systems (ERP) and process control systems
- Implementation of measures to ensure compliance with the requirements for data integrity
- Support in implementing the requirements for IT security according to ISO 27001/ BSI-Standards
Pharmaceutical Quality System (PQS)
- Preparing Product Quality Reviews (PQRs)
- Conducting of mock audits or preparation and follow-up of audits
- Preparing & accompanying of authority inspections
- Supplier management, supplier qualification, auditing and preparing technical agreements
- Deviation management incl. root cause analysis
- Change processes/change management and CAPAs
- Conducting gap analyses
Accompanying of technology and product transfers
- Project management
- Process validation
- Selection of alternative manufacturers
Document management
- Establishing, maintaining and further developing QM systems
- Preparing and revising GMP documents such as Site Master Files, SOPs or manufacturing instructions
- Introduction of document management systems
Training
- Establishing training systems
- Conducting staff training courses