Experience

Nanovi A/S

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Sep 2020 - Present

  Supplier Quality General QMS Transfer of manufacture Eudamed Supplier Quality General QMS Transfer of manufacture Eudamed


TVRmedia
• Poland
• Book and Periodical Publishing
• 1 - 100 Employee
• Consultant

  • 2019 - Present


Cook Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Project Leader

  • 2018 - 2019

  Plan and execute projects Facilitate problem solving Plan and execute projects Facilitate problem solving



Agilent Technologies

• Biotechnology Research
• 700 & Above Employee

• Supplier Quality Specialist

  • 2016 - 2018

  Agilent sells kits and laboratory instruments for diagnostics of cancer Tasks: • Process owner of the supplier complaint system SCAR • Supplier monitoring • Manage quality project • Handle Capa Achievement: Manged implementation of acceptance test of instrument which was part of a CAPA that I overtook in a delayed state. The achievement was recognized and voiced at the Monthly QA meeting headed by the QA director. Agilent sells kits and laboratory instruments for diagnostics of cancer Tasks: • Process owner of the supplier complaint system SCAR • Supplier monitoring • Manage quality project • Handle Capa Achievement: Manged implementation of acceptance test of instrument which was part of a CAPA that I overtook in a delayed state. The achievement was recognized and voiced at the Monthly QA meeting headed by the QA director.



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Engineer

  • 2011 - 2016

  • Technical responsible for contract manufacturing of metal parts • Plan and execute projects • Participate in development projects • Implement changes improvement at suppliers • Testing validation Computer& equipment Achievements: 1) Develop and implement a process fo r scanning products in China. 2) Manage project product modification for Egyptian market. • Technical responsible for contract manufacturing of metal parts • Plan and execute projects • Participate in development projects • Implement changes improvement at suppliers • Testing validation Computer& equipment Achievements: 1) Develop and implement a process fo r scanning products in China. 2) Manage project product modification for Egyptian market.



NNE Pharmaplan

• Consultant Quality Engineer

  • 2004 - 2011

  • Prepare tender • Plan and execute projects • Prepare validation/ test documents For computer, software, Equipment • Requirement management • QA responsible for new document handling system at NovoNordisk • Validation of clinical trial system at Lundbeck • Part 11 gap analysis Achievement: Advise on how to upgrade process control systems to be approved For producing products for clinical trials and execute the project. The budget was 900 000DKK. Project finished within the timeline and budget. The process control system was subsequently approved in an audit and the plant could be used for producing products for clinical trials. Show less



Coloplast

• Denmark
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Engineer

  • 2000 - 2004

  • Increase quality of validation in woundcare division • Responsible for divisional validation master plans • Plan and execute projects • Facilitate risk assessment • Provide validation support to validation of packaging lines, computer and analytical instruments. Achievements: Prepared and implemented an instruction risk management. Prepare and implement design of experiments Prepare and implement procedure on change control • Increase quality of validation in woundcare division • Responsible for divisional validation master plans • Plan and execute projects • Facilitate risk assessment • Provide validation support to validation of packaging lines, computer and analytical instruments. Achievements: Prepared and implemented an instruction risk management. Prepare and implement design of experiments Prepare and implement procedure on change control



Ferring Pharmaceuticals

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Engineer

  • 1996 - 2000

  • QA responsible for a packaging lines, utilities and cleanroom • Manage validation of refurbished cleanroom in aseptic area • Review and approve validations • Review and approve SOPs • QA responsible for a packaging lines, utilities and cleanroom • Manage validation of refurbished cleanroom in aseptic area • Review and approve validations • Review and approve SOPs