Area of responsibilities:- Quality oversight of CMO process unit - External audit of CMOs- Quality oversight of production and activities at the CMO- Maintain and develop specialized knowledge within the field of responsibility- Ensure timely review and QA-approval of CMO documents i.e. Change Controls, Deviations and Validation documents- Participate in process improvement activities across BN and CMOs- Participate as QA-responsible person in improvement and technical transfer projects- Participate in process improvement activities across BN and CMOs

Area of responsibilities:- Lead Auditor for Medical Device Industry (ISO13485)- Project management- Develop and audit the quality systems as part of the transformation of the quality system setup. - Participate and support the implementation of the quality standards. - Government of improvement tools (CAPA´s and Quality planning) - Overall QMS IT system operation- Responsibility for the Corporate QMS- Quality systems - Continuous improvement of QMS- Site support and development - Risk Management - Corporate audits, notified body audits and customer audits all around the world

Area of responsibilities:- Optimization of Quality Management system - Qualification and validation of equipment and process- Quality assurance for Utilities (PW, Steam, WFI)- Data integrity- Participation in audit and inspection as QA and SME- Processing of change records- Optimization of quality management system- Validation of computerized system - Risk management and Risk analysis- Deviation handling and CAPA - Training of new employee (GMP, ISO13485 and deviation handling) - QA representative of projects related to the new production line- Poweruser and trainer for internal IT systems

Area of responsibilities:- Surveillance of GMP/GDP regulations- SuperUser and trainer in various QA IT systems- Support of global and local QA IT systems- Test of new module for deviation in QMS- Implementation of KPI for different QMS process- Improvement projects and implementation of various systems- Support and advice on GMP/GDP related matters to internal stakeholders- Development and review of SOPs covering the QA activities- Participation in internal audits and inspections from authorities- Management, control and archive of GMP documentation

Area of Responsibilities:- Continuous Improvements of Quality processes- Operational support - Cleaning validation- Quality assurance for Utilities (PW, Steam, WFI)- Qualification of producation and lab equipment- Computerized system validation- Data Integrity- Change control - SCADA trending- Deviation and CAPA- Periodic review of equipment- Risk assessment

Area of Responsibilities:- Handling of of deviations (cleaning and process)- Cleaning monitoring - Trend reports- QA presence in production- Cleaning validation- Change request

Dispensing prescription and offering expert advice to customers