Experience

Scott/Tiger A/S - now Miracle 42 A/S

• Denmark
• IT Services and IT Consulting
• 1 - 100 Employee

• Senior Consultant

  • Apr 2010 - Present

  Working as a compliance consultant (e.g. as validation manager or compliance manager) at LEO Pharma and Novo Nordisk since 2010 on various activities related to validation of GxP computerized systems. Typical types of tasks:* Author of validation plans/reports, risk assessments, data migration plans/reports, test plans/reports, system retirement plans/reports, periodic review reports and SOPs.* General compliance guidance to the project team and suppliers and review of deliverables from project team members and suppliers.* Qualification of IT infrastructure and production line equipment.

• Compliance Manager

  • Apr 2010 - Present



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Specialist

  • 1999 - Apr 2010

  Started as the only QA-person in Lundbeck IT and build up the IT QA function by recruiting and training new employees. Key person responsible for designing, building, implementing and maintaining the IT Quality Management System at Lundbeck.Validation manager regarding applicationsQualification manager regarding IT infrastructureQuality control (Q-approvals) of SOP’s and documentationAuthor of corporate SOP’s and IT SOP’s.Responsible for the strategy for IT quality management and the IT QA function.Internal audits and supplier audits.IT coordinator regarding inspections by the authoritiesIT Security



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Team Leader, Project Manager, System Analyst

  • 1994 - 1998

  IT System Development (all phases of the development life cycle)IT system maintenanceIT project Management.Primary area was data warehouse solutions IT System Development (all phases of the development life cycle)IT system maintenanceIT project Management.Primary area was data warehouse solutions



Ambrasoft

• System Analyst

  • 1992 - 1994

  IT System Development (all phases of the development life cycle)IT system maintenanceConsultancy. IT System Development (all phases of the development life cycle)IT system maintenanceConsultancy.



IBM

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• System Analyst and Project Manager

  • 1986 - 1992

  IT System Development (all phases of the development life cycle)IT system maintenanceIT project ManagementConsultancy. IT System Development (all phases of the development life cycle)IT system maintenanceIT project ManagementConsultancy.