Karoline Botten Gundersen Email and Phone Number
Karoline Botten Gundersen work email
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Karoline Botten Gundersen personal email
I am a highly experienced professional with over 30 years of experience in the pharmaceutical industry. I have worked in several areas Manufacturing and Product Development, Quality, Supply Chain, Business Excellence and now IT. Throughout my career, I have consistently delivered high-quality results, working on complex projects for local and global organizations.My approach is characterized by strong organizational skills, good planning, and commitment to quality. I have a continuous learning mindset and strategic thinking, which I use to help organizations improve processes and operations. I am an effective communicator and collaborator, with a proven track record of building strong relationships with stakeholders at all levels of an organization.As project manager, I have successfully led cross-functional teams, and as a people manager, I have created a positive and respectful workplace culture.I am a certified Agile Change Agent (equivalent to LEAN Six Sigma Green Belt), and am certified in ITIL4. I am an extroverted, positive, and enthusiastic individual who values respect and is highly motivated by goal setting and taking responsibility.I am dedicated to ongoing learning and professional development to continuously improve in my role and contribute to the organization's success
Nextpharma
View- Website:
- nextpharma.com
- Employees:
- 343
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Head Of Eu It Support And Service Management ExcellenceNextpharma Jul 2024 - PresentNorwayMember of Global IT Leadership Team (ITLT)Lead IT support teams across all non-German sites, driving the continuous improvement of IT Service Management processes.Responsible for managing IT support staff currently in five locations: Asker (Norway), Ploermel and Limay (France), Edinburgh (UK), and Tampere (Finland).Spearhead efforts to enhance service delivery and operational efficiency, ensuring alignment with global standards and business objectives.Collaborate with cross-functional teams to optimize support processes, ensuring seamless operations across multiple regions.Advise and support in IT quality management processes, including SOPs and GMP documentation.
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Manager Of Global It Service ManagementNextpharma Oct 2023 - Jun 2024NorwayA Global role where I lead our efforts to develop and enhance the IT Service Management framework across NextPharma. Collaborating closely with IT Site Leads and various IT functions, my role focuses on integrating ITIL principles to refine our service delivery. Key responsibilities include:Process Optimization: Continuously improving ITSM processes like Incident, Problem, and Change Management, enhancing response efficiency and service quality.Standardization of Practices: Utilizing Jira Service Desk to standardize ITSM practices across all locations, ensuring consistency and coherence.Communication and Training: Elevating internal IT communications and training within NextPharma to foster a well-informed workforce.Cybersecurity Advocacy: Monitoring and promoting our global cybersecurity awareness program to safeguard corporate assets and data.Oversee global IT policy and SOP landscape to ensure compliance with regulatory requirements.
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It Site Lead (Interim)Nextpharma Apr 2023 - Jun 2024Asker Kommune, Viken, NorgeMember of Site Leadership Team (SLT)As an Interim IT Site Lead at NextPharma Asker site, I am responsible for establishing and integrating the local IT department into the company's global IT organization. This involves developing processes and policies aligned with the organization's IT standards and goals, while ensuring that IT solutions meet the expectations of the SLT and Global IT. My focus is on creating a robust and efficient IT function that supports the Site in daily operations and development.
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It Divestment Local Project LeadTakeda Oct 2022 - Apr 2023Asker Kommune, Viken, NorgeMember of Site Leadership Team (SLT)Led the local IT department through the divestment of the site to NextPharma. Local Project Lead for the overall IT workstream in the divestment and responsible for sub workstream End User Transfer. Role as Business owner for the SAP carveout (Clone & Trim). -
Head Of Site Business ExcellenceTakeda Aug 2019 - Apr 2023Asker, Akershus, NorgeMember of Site Leadership Team (SLT).Program lead for the strategic transformation programs AGILE 4.0Program lead for automation and digitalization in direction Industry 4.0 at Asker manufacturing site.Project Lead implementation of new OT network.Stretegic planning and deployment.Site Digital SPOC
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Site Communication PartnerTakeda Mar 2017 - Apr 2023Norway
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Agile Change LeadTakeda Mar 2017 - Aug 2019Asker, NorwayMember of Site Leadership Team (SLT). Change Lead for Takeda Global LEAN Transformation program AGILE at the Asker site. Details under "Projects".Site Communication Partner (Global Manufacturing Supply Global Quality)Focus: Change management, Strategy, Innovation, Digitalization and Automation.
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Agile Change Agent And Project Management SupportTakeda Dec 2016 - Feb 2017Takeda Asker, NorwayTakeda Global LEAN Transformation program. Project management Support and Change Agent for Management Infrastructure in preparation phase for Agile program in Takeda Asker.
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Agile Change Agent And Pull Forward Resource In Takeda Singen, GermanyTakeda Pharmaceuticals In Europe And Canada Jul 2016 - Nov 2016Singen, Baden-Württemberg, GermanyTakeda Global LEAN Transformation program. The role support the local AGILE program in Takeda Singen, Germany. Change Agent for a specific improvement project within Quality . The Pull Forward role is trained and educated to deploy local AGILE program in home site. Key technologies for the site are Sterile, Liquids and Semi-Solids. The main Products are Panto iv., Riopan and Omnaris The AGILE program works within three dimensions: Operating System, Management Infrastructure and Mindset & Behaviour.
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Quality Advisor / Sap Qa, Quality Systems & Quality ComplianceTakeda Jul 2015 - Jul 2016Asker, NorwayThe role support quality assurance and validation (CSV) of SAP and GxP Computerized Systems at the Asker plant. Is quality advisor in projects for new installation or upgrade of GxP computerized system e.g. SAP, WMS, EMS, Automated guided vehicle (AGV), Serialization.Validation Lead and Project Management.Maintenance and continuous improvement of the Quality Management Systems including implementation of global company and regulatory requirements. Process responsible for CAPA. Leader of Validation Steering Committee at the factory.
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Quality Advisor / Sap Qa, Quality Assurance Dept.Takeda Nycomed As Jun 2012 - Jun 2015Norway, AskerQuality assurance and validation of SAP and GxP Computerized Systems at the Asker plant. Quality advisor in projects for new installation or upgrade of GxP computerized system e.g. SAP, WMS, EMS, Automated guided vehicle (AGV), Serialization.Validation Lead and Project Management.Maintenance and continuous improvement of the Quality Management Systems including implementation of global company and regulatory requirements. Process Responsible for CAPA in EQMS.
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Director Product Development (Contract Manufacturing Business)Inpac As Feb 2011 - Mar 2012Contract ManufacturingMember of Site Leadership Team at Inpac AS.Contributor new business and bid support.Project manager development projects (pharmaceuticals and life science products) and tech transfer for contract manufacturing.Product- and process development, scale-up and validation (IQ, OQ, PQ,PV).Documentation for Marketing Authorization.Cleaning validation.Continuous improvement - GMP, work processes
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Senior Project ManagerActavis Lier (Inpac As) Feb 2010 - Feb 2011Quality improvement project. Development and implementation of work process and documentation system for creation and approval of manufacturing recipies (Production Master).Development and implementation of work process for issuance of batch documents.Training of operators in filling out batch manufacturing records (BMR).Improvement of several procedures (SOPs) in Production.Process validation tasks. -
Adviser Product DevelopmentActavis Lier (Inpac As) Dec 2007 - Feb 2010Project manager and/or discipline leader for development and implementation of new or changed pharmaceutical products and medical devicesAdvisor to employees and customers related to products and processes.Changes in raw materials, optimization of formulations and manufacturing processes.Planning, implementation and reporting of manufacturing trials in pilot and production.Tech transfer of manufacturing process for new products and manufacturing processes including process validation and cleaning validation.Preparation of regulatory documentation for Marketing Authorization for new and changed products.Preparation of PQR (Product Quality Review), manufacturing part.Professional adviser in deviation handling, change control and risk assessmentProfessional resource with responsibility for training in production.Document review and approvalBid support new product development and/or manufacturing assignments.
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Adviser Supply ChainNycomed Pharma 2006 - 2007Documentation system for Batch Manufacturing Records (SAP & Adobe output)Project Manager; Review of validation status computerized systems (production equipment, analytical systems and production supply systems.)Project member implementation of Engeneering Change Management (ECO) PP module in SAP. Project member implementation of new intranet solution Nycomed Norway.In-plant training
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Adviser Production TechnologyNycomed Pharma 2000 - 2006Documentation system for Batch Manufacturing Records (SAP & Adobe output)Key user SAP R/3 PP moduleProject member Internal Documentation System plant AskerProject ManagementProcess validationGMP improvementsIn-plant training
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Adviser Production SupportNycomed Pharma Jan 1998 - Dec 1999Various positions as project member:Production Masters for BMR's (SAP & Adobe output)Coordinator for operator training.GMP improvementsIn-plant training
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Local Support - Document MaintenanceNycomed Pharma Sep 1995 - Dec 1997Development and maintenance of internal document system. (Internal spesifications and methods for raw materials, bulk and finish product.)GMP-training.
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Quality Control SupportNycomed Pharma Oct 1994 - Aug 1995Support to QC department in plant Asker and plant Oslo.Quality control of pharmaceuticals and nutraceuticals (raw materials, bulk, finish product and packaging materials).Internal document system for chemicals used in the laboratory.
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Project Member QaNycomed Pharma Jan 1993 - May 1993Establishment of production masters in new material management system (SAP).
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Trainee ProductionNycomed Pharma Aug 1990 - Jul 1991Pharmaceutical manufacturing; Granulation, Tabletting, Coating (sugar) and powder mixtures.
Karoline Botten Gundersen Skills
Karoline Botten Gundersen Education Details
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Norwegian University Of Science And Technology (Ntnu)Digitalization And Digital Transformation (7.5 Ects) -
The National Institute Of Technology, NorwayKvalitetsleder Teknologisk Institutt
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The National Institute Of Technology, NorwayKv8 - Revision (Equivalent 5 Ectc)
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The National Institute Of Technology, NorwayK01-Introduction To Quality Management (Equivalent 5 Ectc)
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The National Institute Of Technology, NorwayKv4-Lean Six Sigma With Statistic (Equivalent 5 Ectc)
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The National Institute Of Technology, NorwayKo2 – Building Quality Management Systems (Equivalent 5 Ectc)
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The National Institute Of Technology, NorwayK03 - Improvement Processes (Equivalent 5 Ectc)
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Bjørknes Høyskole (Bjørknes College)University Foundation Course In Medicine (60 Ects )
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Part Of B.Sc.: Chemistry Courses, Biochemistry, Statistics, Mathematics And German (133 Ects) -
Drammen GymnasNaturfaglinje
Frequently Asked Questions about Karoline Botten Gundersen
What company does Karoline Botten Gundersen work for?
Karoline Botten Gundersen works for Nextpharma
What is Karoline Botten Gundersen's role at the current company?
Karoline Botten Gundersen's current role is Strategic Leader | Head of EU IT Support and Service Management Excellence at NextPharma.
What is Karoline Botten Gundersen's email address?
Karoline Botten Gundersen's email address is ka****@****sen.com
What schools did Karoline Botten Gundersen attend?
Karoline Botten Gundersen attended Norwegian University Of Science And Technology (Ntnu), The National Institute Of Technology, Norway, The National Institute Of Technology, Norway, The National Institute Of Technology, Norway, The National Institute Of Technology, Norway, The National Institute Of Technology, Norway, The National Institute Of Technology, Norway, Bjørknes Høyskole (Bjørknes College), University Of Oslo (Uio), Drammen Gymnas.
What skills is Karoline Botten Gundersen known for?
Karoline Botten Gundersen has skills like Gmp, Document Review, Quality Assurance, Quality Auditing, Compliance Audits, Project Management, Product Development, Technology Transfer, Process Validation, Cleaning Validation, Production, Contract Manufacturing.
Who are Karoline Botten Gundersen's colleagues?
Karoline Botten Gundersen's colleagues are Jannick Meinecke, Melani Ignatova, Zahra Dawood, Elina Podesta, Sercan Demir, Merab Tsiklauri, Nicole Müller.
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