Experience

Vironova AB

• Sweden
• Biotechnology Research
• 1 - 100 Employee

• Senior QA Manager

  • Jun 2021 - Present

  • QA representative in projects and validations / qualifications• QA review of documents, validation activities and investigations • QMS improvement and efficiency• GxP and quality trainings• Audits and inspections• Organisational support within area of my expertise • QA representative in projects and validations / qualifications• QA review of documents, validation activities and investigations • QMS improvement and efficiency• GxP and quality trainings• Audits and inspections• Organisational support within area of my expertise



Arta Plast AB

• Sweden
• Plastics Manufacturing
• 1 - 100 Employee

• Projektledare & KAM - Medical Devices

  • Sep 2019 - Jun 2021

  - Project manager - coordinate resources, design review, risk analysis, material selection, calculations, fulfillment of user requirements and ISO 13485- Key Account Manager/technical sales support - customer contact for offers and ongoing projects/ production- Product owner - development, changes, CAPA and other quality issues throughout the product life cycle- Process validation - plan, perform and report process validation of injection molding process /automated assembly of injection molded products



Q-linea

• Sweden
• Medical Device
• 100 - 200 Employee

• Valideringsledare (uppdrag genom Complyit)

  • May 2019 - Aug 2019

  Process Validation of in vitro diagnostic Medical devices, consumablesQMS developmentISO 13485 Medical devices Quality ManagementIVDR/MDR new Regulations Process Validation of in vitro diagnostic Medical devices, consumablesQMS developmentISO 13485 Medical devices Quality ManagementIVDR/MDR new Regulations



Complyit AB

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant

  • Oct 2013 - Aug 2019

  Quality Assurance, Project Management, Validation & Qualification, Process Development Quality Assurance, Project Management, Validation & Qualification, Process Development



TSS

• Sweden
• Transportation, Logistics, Supply Chain and Storage
• 1 - 100 Employee

• Quality Manager (assignment through ComplyiT)

  • Apr 2017 - Mar 2018

  Quality Management within: - Agile Software Development- Computerized system & software validation- Device Manufacturing- ISO 9001:2015 quality management system - GAMP Approach to compliant GxP system- Audits Quality Management within: - Agile Software Development- Computerized system & software validation- Device Manufacturing- ISO 9001:2015 quality management system - GAMP Approach to compliant GxP system- Audits



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager (assignment through ComplyiT)

  • Mar 2015 - Apr 2017

  Project manager for Capital investment projects including: - budget, time and resource planning - User requirements specifications- Risk analysis- external supplier contacts - Comissioning Lead- GMP classified equipment- SHE / environmental classified equipment Project manager for Capital investment projects including: - budget, time and resource planning - User requirements specifications- Risk analysis- external supplier contacts - Comissioning Lead- GMP classified equipment- SHE / environmental classified equipment



Nobel Biocare

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• Process Develpment Engineer (consultant assignment through ComplyiT)

  • Aug 2014 - Mar 2015

  - Process Development- Line Extension of new products in existing lines- Process Verification- User requirement specifications- Installation verification- Computerized system & software validation

• Validation Leader (consultant assignment through ComplyiT)

  • Oct 2013 - Nov 2014

  Computerized system Validation lead:- Inorporation of production management system into SAP, including electronic records and electronic signatures- validation of software applications- GAMP5- risk based approach- change control and release control- responsible for developing validation plan, test protocols and reports- execution of tests- dental implants and dental prosthetics manufacturing sites

• Process Development Engineer

  • Jul 2013 - Oct 2013

  Process DevelopmentProcess VerificationProcess Validation, IQ/OQ- dental prosthetics, ceramic products

• Technical Project Manager

  • May 2012 - Jun 2013

  Responsible for planning, executing and controlling Product Development project work from feasibility phase until hand over to launch manager. Responsible for compiling a complete Technical file according to regulations for product launch on the European, US and worldwide market.- dental prosthetics and restorative products



Boule Diagnostics AB

• Sweden
• Medical Device
• 1 - 100 Employee

• Project Manager

  • Aug 2007 - May 2012

  Product Development projects in Medical Devices- feasibility, planning, development and production transfer- verification & validation- point of Care product- injection mould product- hematology instruments- blood status diagnostics

• Development engineer

  • Mar 2005 - Aug 2007

  New product Development of medical devicesR&D activitiesFeasibility studiesInjection mouldsBlood status diagnostics



SATS

• Norway
• Wellness and Fitness Services
• 700 & Above Employee

• Group training instructor

  • Nov 2008 - Apr 2011