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(Uppdaterat 1+ år sedan)IT Quality & Compliance manager
København, Danmark
Modersmål Danish, English, Mellan Svenska
- Test management, Lead auditor
- 15+ års pharma erfaring
- 15+ års erfaring med IT Quality & Compliance
Kompetenser (22)
STRATEGIC SOURCING
RFP
CHANGE CONTROL
CONTRACTS
LIFE SCIENCE
QUALITY ASSURANCE
IT SOURCING
GMP
VENDOR SELECTION
TCO
CAPA
AUDIT
SOPS
SUPPLIER MANAGEMENT
B2B
Procurement
GxP
CONTRACT MANAGEMENT
Change Management
BUSINESS CASE
IT Project Management
ORGANIZATIONAL CHANGE
Sammanfattning
In my life science career (18+ years of experience), I have worked for both some of the world's biggest
life science companies and held positions at small biotech companies. I have worked at various levels:
With general management as a manager, as a generalist and as a specialist. I have worked with IT
Project Management, IT Sourcing, IT Quality Assurance and IT Compliance. The common denominator
for all my positions is that I have worked with, and around, IT in the life science industry.
I assist clients as a consultant in activities such as:
Project management
IT Sourcing Negotiation Contracts Supplier management
IT Quality Assurance IT Compliance IT Audits
-PRINCE2 Foundation certified
-EU GDPR Foundation certified
-B2B negotiator certified
-ITIL Foundation certified
-ISEB Foundation certified
-ISO 9000:2008 Auditor/Lead Auditor certified
I engage with a professional and confident attitude. I possess strong communication, facilitation and
commercial skills and believe that stakeholder management is key to success in any project.
Resume in brief
Jesper Birk Østergaard
Mobile: +45 2551 8721
https://www.linkedin.com/in/jesperoestergaard/
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Professionell bakgrund
Consultant - Compliance Manager - Tracklead
LEO Pharma
2019-01 - Pågående
Project: Serilization project - Upgrade of LEO Pharma level 1-3
serialisation solution (production line software). Involved in the analysis
phase with validation & test strategy and related V-model/(waterfall model implementations) activities for Serilization level 3-1 systems.
Includes handling IT suppliers (Antares Vision) compliance activities.
Includes change controls, deviations, training, SOP & WI's.
serialisation solution (production line software). Involved in the analysis
phase with validation & test strategy and related V-model/(waterfall model implementations) activities for Serilization level 3-1 systems.
Includes handling IT suppliers (Antares Vision) compliance activities.
Includes change controls, deviations, training, SOP & WI's.
Consultant - Test & Compliance Manager - Tracklead
LEO Pharma
2019-01 - 2019-03
Project: Responsible for inspection of LEO SAP Serialisation system by
DKMA (Danish Medicines Agency). Plan and prepare for inspections.
Ensure resources and system documentation are in place. Participation in opening and closing meetings. Lead discussion with DKMA inspectors.
DKMA (Danish Medicines Agency). Plan and prepare for inspections.
Ensure resources and system documentation are in place. Participation in opening and closing meetings. Lead discussion with DKMA inspectors.
Consultant - Test & Compliance Manager - Tracklead
LEO Pharma
2017-07 - 2019-03
Project: Serilization project - Integration SAP ATTP with 10+ CMOs, EU
HUB (EMVS) and cloud broker (SAP ICH). Validation strategy, plan & reporting and related V-model/(waterfall model implementations)
activities for Serilization level 3, 4 & 5 systems (production line sw, SAP ATTP & PO and CMO & cloud broker integration). Includes GAMP
category 3, 4 & 5 software. Includes handling IT outsourcing partners
compliance activities. Includes change controls, deviations, training, SOP
& WI's.
Tracklead reponsible for compliance activities and deliverables, and a team of 3-5 ressources that includes compliance & test managers,
configuration manager and document manager.
GLOSSIII (the project) delivered 4 releases (4 full V- models/implementations) from August 2018 to January 2019
Ju
HUB (EMVS) and cloud broker (SAP ICH). Validation strategy, plan & reporting and related V-model/(waterfall model implementations)
activities for Serilization level 3, 4 & 5 systems (production line sw, SAP ATTP & PO and CMO & cloud broker integration). Includes GAMP
category 3, 4 & 5 software. Includes handling IT outsourcing partners
compliance activities. Includes change controls, deviations, training, SOP
& WI's.
Tracklead reponsible for compliance activities and deliverables, and a team of 3-5 ressources that includes compliance & test managers,
configuration manager and document manager.
GLOSSIII (the project) delivered 4 releases (4 full V- models/implementations) from August 2018 to January 2019
Ju
Senior Manager
BASE life
2016-06 - 2018-01
Employed as a consultant. Besides being allocated to projects and
invoicing at clients, I assisted the company in growing in relation to strategy, sales and processes.
invoicing at clients, I assisted the company in growing in relation to strategy, sales and processes.
Consultant - Project Manager
Novo Nordisk
2017-09 - 2018-01
Project: Transition project - change of global WAN supplier for client from one supplier to another including handling of service integrator.
Scope and stakeholders involves customer HQ and all affiliates. Scope also includes a detailed migration analysis based on the client's
connectivity strategy, introducing less MPLS and more internet to cater
for future cloud requirements and to optimize cost. Reporting to Stc and head of Infrastructure
Scope and stakeholders involves customer HQ and all affiliates. Scope also includes a detailed migration analysis based on the client's
connectivity strategy, introducing less MPLS and more internet to cater
for future cloud requirements and to optimize cost. Reporting to Stc and head of Infrastructure
Consultant - Project Manager
Zealand Pharma
2017-07 - 2018-01
Project: IT Project Management and IT Compliance for implementation
of new EDMS, including acting on behalf of client towards supplier and
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
authoring validation master plan, data migration plan and risk
assessment
of new EDMS, including acting on behalf of client towards supplier and
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
authoring validation master plan, data migration plan and risk
assessment
Consultant - Quality Assurance for IT
Zealand Pharma
2017-01 - 2018-01
Project: Design, development and implementation of new IT QMS,
including authoring of procedures for IT lifecycle, system impact
assessment and IT audits
including authoring of procedures for IT lifecycle, system impact
assessment and IT audits
Consultant - Lead auditor
Zealand Pharma
2017-11 - 2017-12
Project: Lead auditor for audit of Global IT supplier (US based) for client.
Audit was conducted onsite and based on ISO9001:2015 and GAMP5,
including planning, execution and reporting of findings
Audit was conducted onsite and based on ISO9001:2015 and GAMP5,
including planning, execution and reporting of findings
Consultant - Sourcing Project Manager / Negotiator
Novo Nordisk
2017-04 - 2017-09
Project: Sourcing of global WAN supplier through clients sourcing model,
including RFP process and negotiations
including RFP process and negotiations
Consultant
Novo Nordisk
2017-05 - 2017-08
Project Manager
Project: Customer has entered into a new 5-year agreement with their IT
infrastructure outsourcing supplier. Project management of transition from old agreement to new agreement covering all infrastructure
services and reporting to Stc and head of Infrastructure
Project: Customer has entered into a new 5-year agreement with their IT
infrastructure outsourcing supplier. Project management of transition from old agreement to new agreement covering all infrastructure
services and reporting to Stc and head of Infrastructure
Consultant
Novo Nordisk
2016-11 - 2017-08
Sourcing Project Manager / Negotiator
Project: Sourcing project management, contracting and negotiation for
replacement of identity access management (UserAR2 replacement project)
Project: Sourcing project management, contracting and negotiation for
replacement of identity access management (UserAR2 replacement project)
Consultant Project manager supervising consultants
Zymphogen
2017-06 - 2017-06
Project: Design, development and implementation of new IT QMS and handling audit findings
Consultant
Novo Nordisk
2016-06 - 2017-05
Sourcing
Project Manager
Project: Sourcing advisory, review and assistance to the QBIQ (EDMS)
project during the RFP phase, including strategy for market approach and supplier communication, authoring cover letter, ensuring coherence
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk of RFP documents, alignment of NN contract templates and preparation
of negotiation strategy.
Project Manager
Project: Sourcing advisory, review and assistance to the QBIQ (EDMS)
project during the RFP phase, including strategy for market approach and supplier communication, authoring cover letter, ensuring coherence
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk of RFP documents, alignment of NN contract templates and preparation
of negotiation strategy.
Consultant Project manager supervising consultant
Ascendis Pharma
2016-11 - 2016-12
Project: Postal audit of EDMS supplier
Consultant - Quality Assurance for API / Equipment
Alvotech
2016-06 - 2016-12
Project: Alvotech is building a new Biosimilars API and filling facility on
Iceland. Act as internal QA for Alvotech for API equipment for up- and downstream processes. Review and approval of qualification
deliverables on VPP, URS, SAT, IQ, OQ & PQ. Assist with updating internal
QMS.
Iceland. Act as internal QA for Alvotech for API equipment for up- and downstream processes. Review and approval of qualification
deliverables on VPP, URS, SAT, IQ, OQ & PQ. Assist with updating internal
QMS.
Consultant
Ascendis Pharma
2016-06 - 2016-10
Project: Sourcing of new EDMS system. Review and advisory to sourcing
strategy, cover letters and questionnaires.
strategy, cover letters and questionnaires.
Consultant
Novo Nordisk
2016-06 - 2016-06
Project: Development TCO calculator template for client. Create a Total
Cost of Ownership spreadsheet template that contain all possible cost
associated with either an on premise or SaaS solution.
Cost of Ownership spreadsheet template that contain all possible cost
associated with either an on premise or SaaS solution.
Sourcing Project Manager / Negotiator
LEO Pharma, Global Sourcing
2014-11 - 2016-06
Project: Analysis on EDMS Upgrade/Replacement and vendor selection to select supplier for new EDMS. Comprehensive analysis on cross
organizational requirements to a new corporate EDMS solution covering
eTMF, QMS and Research. Selection of supplier through a thorough 7-
step sourcing model, including RFP process and negotiations
Nov 2014- Jun 2016
Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection of new global
Travel agency for LEO Pharma.
Vendor selection through a thorough 7-step sourcing model, including
RFP process and negotiations
Nov 2014 - Jun 2016 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Transition project - Implementing a new travel agency, including
setting up new procedures between supplier and LEO and flows in SAP
organizational requirements to a new corporate EDMS solution covering
eTMF, QMS and Research. Selection of supplier through a thorough 7-
step sourcing model, including RFP process and negotiations
Nov 2014- Jun 2016
Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection of new global
Travel agency for LEO Pharma.
Vendor selection through a thorough 7-step sourcing model, including
RFP process and negotiations
Nov 2014 - Jun 2016 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Transition project - Implementing a new travel agency, including
setting up new procedures between supplier and LEO and flows in SAP
Project Manager / Change Manager
LEO Pharma, Global Sourcing
2014-11 - 2016-06
Project: Transition project - Implementing a new Telephony provider.
Development of transition strategy and implementing +1200 users from Telenor to Hi3G, including transition from ADSL to Mobile Broadband.
Strategy and architectural framework for 6 new supporting processes.
Project Management of resources from Netplan, Hi3G, Telenor, LEO, IBM and subcontractors. Organizational change management.
Development of transition strategy and implementing +1200 users from Telenor to Hi3G, including transition from ADSL to Mobile Broadband.
Strategy and architectural framework for 6 new supporting processes.
Project Management of resources from Netplan, Hi3G, Telenor, LEO, IBM and subcontractors. Organizational change management.
Business Implementation Manager / Project Manager / Change
LEO Pharma, Global Sourcing
2014-11 - 2016-06
Manager
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Project: Implementing new PTP (procure to pay) process in GLOBE (SAP).
Project management and Organizational change management of new
PTP (procure to pay) process. Project management of Sourcing, Finance,
SAP project and vendor resources. Planning and execution of ramp
down/up activities, test, hyper care & support.
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Project: Implementing new PTP (procure to pay) process in GLOBE (SAP).
Project management and Organizational change management of new
PTP (procure to pay) process. Project management of Sourcing, Finance,
SAP project and vendor resources. Planning and execution of ramp
down/up activities, test, hyper care & support.
Head of department
LEO Pharma, Global Sourcing
2014-11 - 2016-06
IT, Telecom & Travel sourcing
Responsible for strategic sourcing, negotiation and supplier management on all projects managed by the department. Establish and execute
category plans to mature methodology, process and toolbox.
Outsourcing of business processes and restructuring department to 6
employees including Category Managers and Sourcing Specialists.
Participated in Steering Committees. Daily coaching and support to employees. Stakeholder management of internal customers.
Responsible for strategic sourcing, negotiation and supplier management on all projects managed by the department. Establish and execute
category plans to mature methodology, process and toolbox.
Outsourcing of business processes and restructuring department to 6
employees including Category Managers and Sourcing Specialists.
Participated in Steering Committees. Daily coaching and support to employees. Stakeholder management of internal customers.
Senior Procurement Manager, IT & Telecom
LEO Pharma, Global Sourcing
2012-03 - 2014-11
Responsible for category management, sourcing, negotiation, supplier
management and contract management of all aspects within IT & Telecom, including Software Services, Consultants, Hardware,
Infrastructure, WAN, Outsourcing, Support and Maintenance, Licenses,
Software as a Service, etc. Develop the IT sourcing function into a high
performing category with category strategies and close stakeholder
relations. Develop and implement sourcing processes and clear roles and responsibilities between internal stakeholders.
management and contract management of all aspects within IT & Telecom, including Software Services, Consultants, Hardware,
Infrastructure, WAN, Outsourcing, Support and Maintenance, Licenses,
Software as a Service, etc. Develop the IT sourcing function into a high
performing category with category strategies and close stakeholder
relations. Develop and implement sourcing processes and clear roles and responsibilities between internal stakeholders.
Manager
LEO Pharma, Global Sourcing
2012-03 - 2014-11
Project: Contract Lifecycle Management System - Business case.
Comprehensive analysis on cross organizational requirements to a new
corporate CLM system with the purpose getting business case approval before entering into the sourcing (concept) phase.
Comprehensive analysis on cross organizational requirements to a new
corporate CLM system with the purpose getting business case approval before entering into the sourcing (concept) phase.
Sourcing Project Manager / Negotiator
LEO Pharma, Global Sourcing
2012-03 - 2014-11
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Project: Payroll implementation project - dispute settlement on fixed
price project extension. Agreement on pricing, terms and utilization of supplier resources.
Mar 2012- Nov 2014
Employed at LEO Pharma,
Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select software and implementation partner for a Clinical Data Review System
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select software and implementation partner for a Training Material Development System
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select new provider for fixed
net telephony, mobile telphony and mobile broadband for all Danish
sites and employees
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: GLOBE ERP (SAP) implementation extension. Comprehensive
project and TCO analysis. Negotiation strategy to settle on extension of very large fixed price project. Agreement on pricing, terms and utilization of supplier resources.
Mar 2012- Nov
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Project: Payroll implementation project - dispute settlement on fixed
price project extension. Agreement on pricing, terms and utilization of supplier resources.
Mar 2012- Nov 2014
Employed at LEO Pharma,
Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select software and implementation partner for a Clinical Data Review System
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select software and implementation partner for a Training Material Development System
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: Vendor selection through a thorough 7-step sourcing model,
including RFP process and negotiations to select new provider for fixed
net telephony, mobile telphony and mobile broadband for all Danish
sites and employees
Mar 2012 - Nov 2014 Employed at LEO Pharma, Global Sourcing
Role: Sourcing Project Manager / Negotiator
Project: GLOBE ERP (SAP) implementation extension. Comprehensive
project and TCO analysis. Negotiation strategy to settle on extension of very large fixed price project. Agreement on pricing, terms and utilization of supplier resources.
Mar 2012- Nov
Sourcing Project Manager / Negotiator
LEO Pharma, Global Sourcing
2014-01 - 2014-01
Project: Out of support - Documentum installation. GxP and business
critical systems run on old versions of Documentum. Comprehensive
analysis on cross organisational requirements. Settlement with supplier on a commercial best effort agreement.
critical systems run on old versions of Documentum. Comprehensive
analysis on cross organisational requirements. Settlement with supplier on a commercial best effort agreement.
Auditor
LEO Pharma, Global QA
2009-05 - 2012-03
Projects: Audits of supplier - Siemens / ATOS - Aris Global. Audit of potential suppliers based upon ISO 9000:2008, including establishing
methodology, process and toolbox.
methodology, process and toolbox.
Project Manager / Change Manager
LEO Pharma, Global QA
2009-05 - 2012-03
Project: New IT Quality Management System (QMS). Project
management and organizational change management on implementing
new LEO IT QMS based on GAMP5, including strategy, design,
development and implementation of +20 processes (policies, guidelines and SOPs). Project Management of resources from LEO and vendors.
May 2009- Mar 2012
Employed at LEO Pharma, Global QA
Role: Project Manager
Projects: Responsible for inspections of IT GxP systems by MHRA, DKMA and FDA. Plan and prepare for inspections. Ensure that relevant system
owners and system documentation are in place, including system
inventory. Participation in opening and closing meetings. Lead discussion with auditors.
management and organizational change management on implementing
new LEO IT QMS based on GAMP5, including strategy, design,
development and implementation of +20 processes (policies, guidelines and SOPs). Project Management of resources from LEO and vendors.
May 2009- Mar 2012
Employed at LEO Pharma, Global QA
Role: Project Manager
Projects: Responsible for inspections of IT GxP systems by MHRA, DKMA and FDA. Plan and prepare for inspections. Ensure that relevant system
owners and system documentation are in place, including system
inventory. Participation in opening and closing meetings. Lead discussion with auditors.
QA IT Specialist
LEO Pharma, Global QA
2009-05 - 2012-03
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Responsible as QA on GxP IT system implementations and for IT system
operation departments, primarily within the business areas of IT,
Pharmacovigilance, Regulatory Affairs Support, Quality Assurance & Clinical Data Management. Tasks included: Change Control and Deviation
handling, planning, execution and reporting on internal and external
audits, being responsible QA for IT on authority inspections, advisory on
development and implementation of validation and test strategies
May 2009 - Mar 2012 Employed at LEO Pharma, Global QA
Role: QA IT Specialist
Projects: Implementations or upgrades of very large GxP systems,
including: Adverse Event Management System, Regulatory Information
Management System, Regulatory and eSubmission Systems, Quality
Management System, CAPA system, Clinical Trial Management System & IT Infrastructure. Responsibilities included advisory, review and approval of validation and test strategies and plans, URS, FS, DS, IQ, OQ, PQ,
traceability matrices, CIL and validation reports, release for use.
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Responsible as QA on GxP IT system implementations and for IT system
operation departments, primarily within the business areas of IT,
Pharmacovigilance, Regulatory Affairs Support, Quality Assurance & Clinical Data Management. Tasks included: Change Control and Deviation
handling, planning, execution and reporting on internal and external
audits, being responsible QA for IT on authority inspections, advisory on
development and implementation of validation and test strategies
May 2009 - Mar 2012 Employed at LEO Pharma, Global QA
Role: QA IT Specialist
Projects: Implementations or upgrades of very large GxP systems,
including: Adverse Event Management System, Regulatory Information
Management System, Regulatory and eSubmission Systems, Quality
Management System, CAPA system, Clinical Trial Management System & IT Infrastructure. Responsibilities included advisory, review and approval of validation and test strategies and plans, URS, FS, DS, IQ, OQ, PQ,
traceability matrices, CIL and validation reports, release for use.
IT Compliance Specialist
Genmab A/S
2007-03 - 2009-04
Projects: Responsible for IT Compliance. Strategy design, development and implementation of IT Compliance plan. Advisory on development
and execution of validation and test strategies for colleagues in IT.
Mar 2007- Apr 2009
Employed at Genmab A/S, I
T
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Role: Project Manager
Project: Implementations or upgrades of GxP systems, including: Quality
Management System, Regulatory eSubmission System and Clinical Data
Management System
and execution of validation and test strategies for colleagues in IT.
Mar 2007- Apr 2009
Employed at Genmab A/S, I
T
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Role: Project Manager
Project: Implementations or upgrades of GxP systems, including: Quality
Management System, Regulatory eSubmission System and Clinical Data
Management System
Project manager
Genmab A/S
2007-03 - 2009-04
Project: Design, development and implementation of ITIL Change,
Release & Configuration Management processes
Release & Configuration Management processes
project management
Novo Nordisk
2006-01 - 2006-01
Project: Validation project for new Label printers in Clinical trial supplies.
General project management, coordination of resources and ensuring
communication to the business.
Role: Consultant-
Project Manager and commercial responsible
General project management, coordination of resources and ensuring
communication to the business.
Role: Consultant-
Project Manager and commercial responsible
Consultant
Arla Foods
2005-01 - 2005-01
Project Manager / Change Manager
Project: Roll out of new client platform to Arla. One of NNITs first
external clients contracted to implement a new client platform for their
users. General project management, developing guidelines and ensuring
communication
Project: Roll out of new client platform to Arla. One of NNITs first
external clients contracted to implement a new client platform for their
users. General project management, developing guidelines and ensuring
communication
Consultant - System Manager representative (maternity cover)
Novo Nordisk
2003-07 - 2004-07
Role: Consultant - System Manager representative (maternity cover)
Project: QBIQ system management. One-year assignment. Responsible for functional management of the Novo Nordisk GxP system for handling
quality documents.
Project: QBIQ system management. One-year assignment. Responsible for functional management of the Novo Nordisk GxP system for handling
quality documents.
Customer service
NNIT A/S
2001-06 - 2003-06
Client: Novo Nordisk & Novozymes
Role: IT Customer Consultant (end user support), including onsite and helpdesk support for HW & SW
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Role: IT Customer Consultant (end user support), including onsite and helpdesk support for HW & SW
aroundIT ApS
- CVR-nr.: 39236605
Tlf.: +45 2551 8721 - E-mail: jesper@aroundit.dk
Akademisk bakgrund
AP degree
2019-11 - 2008-01
Certifikat
Foundation Certificate
Certificate in Project Management
Certificate in Project
Foundation certified
CAPA
ISEB Foundation Certificate in software testing
Foundation Certificate in software testing
Certificate in software testing
MCP
Certified B2B negotiator (DILF)
ISPE Europe Annual Conference (Data integrity)
Data integrity and IT Infrastructure event w/Siôn Wyn (BASE life science)
Fra faglig specialist til personaleleder - (CfL)
(CfL)
Fra faglig specialist til personaleleder -
IT kontraktforhandling (Zangenberg)
(Zangenberg)
IT kontraktforhandling
Forhandlingsteknik - Module 3 (DILF)
Forhandlingsteknik
Module 2 (DILF)
(DILF)
Module 2
Gartner IT Financial, Procurement & Asset Management Summit (Gartner)
(Gartner)
Gartner IT Financial, Procurement & Asset Management Summit
Gartner Outsourcing & Strategic Partnerships Summit (Gartner)
(Gartner)
Gartner Outsourcing & Strategic Partnerships Summit
PIC/S intro (LEO Pharma)
EU GMP intro (LEO Pharma)
US FDA intro (LEO Pharma)
ITIL Foundation v.3 (SSF)
ISPE Training Course in Practical
application of GAMP 5 (ISPE)
(ISPE)
application of GAMP 5
ISPE GAMP Conference Brussels and seminar guided tour of GAMP GPG
ISO 9000:2008 Auditor/Lead Auditor
GXP seminar (Genmab)
IT Sikkerhed 1-3 (PwC)
Technical Fundamentals of Documentum (EMC)
ITIL Foundation v.2 (Dansk IT)
2004 IBM project management FA13D course (IBM)
2004 NNIT Academy, Pharma understanding (NNIT)
NNIT Academy, Quality (NNIT)
(NNIT)
NNIT Academy, Quality
2003 Project Management course (Teknologisk Institut)
2002 21 CFR Part (Novo Nordisk)
2002 GMP and Validation (Novo Nordisk)