Magdalena Zeberg
Senior QA Manager at Vironova AB- Claim this Profile
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Bio
Experience
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Vironova AB
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Sweden
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Biotechnology Research
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1 - 100 Employee
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Senior QA Manager
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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
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Arta Plast AB
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Sweden
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Plastics Manufacturing
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1 - 100 Employee
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Projektledare & KAM - Medical Devices
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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
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Q-linea
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Sweden
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Medical Device
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100 - 200 Employee
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Valideringsledare (uppdrag genom Complyit)
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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
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Complyit AB
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Sweden
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Consultant
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Oct 2013 - Aug 2019
Quality Assurance, Project Management, Validation & Qualification, Process Development Quality Assurance, Project Management, Validation & Qualification, Process Development
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TSS
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Sweden
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Transportation, Logistics, Supply Chain and Storage
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1 - 100 Employee
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Quality Manager (assignment through ComplyiT)
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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
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AstraZeneca
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Manager (assignment through ComplyiT)
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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
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Nobel Biocare
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Switzerland
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Medical Equipment Manufacturing
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700 & Above Employee
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Process Develpment Engineer (consultant assignment through ComplyiT)
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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
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Validation Leader (consultant assignment through ComplyiT)
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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
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Process Development Engineer
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Jul 2013 - Oct 2013
Process DevelopmentProcess VerificationProcess Validation, IQ/OQ- dental prosthetics, ceramic products
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Technical Project Manager
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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
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Boule Diagnostics AB
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Sweden
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Medical Device
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1 - 100 Employee
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Project Manager
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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
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Development engineer
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Mar 2005 - Aug 2007
New product Development of medical devicesR&D activitiesFeasibility studiesInjection mouldsBlood status diagnostics
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SATS
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Norway
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Wellness and Fitness Services
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700 & Above Employee
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Group training instructor
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Nov 2008 - Apr 2011
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Education
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Linköping University
Master of Science, Engineering biology -
The Institute of Technology at Linköping University
Master of Science in Engineering Biology, Teknisk Biologi