Qualitätsmanagement / QS / QA (IT)
Risikomanagement
IT-Governance
Transition Management
Transformation Management
Digitalisation Life Science & Healthcare/ Lean & Agile QMS-Regulatory Compliance
Profil-ID 52247293
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Basel |
asap |
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Freiberuflich |
Berufs-/Projekterfahrung
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10/2015 - 12/2015 Dauer 3 Monate |
Rolle IT Project Quality Manager, IT Transition |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben • Ensuring that the transition projects and applications are managed in compliance with IGM require-ments, e.g. Novartis project management methodology (“ICE”) • Validating all project and system life cycle documents in compliance with IGM/ICE and CSV to force the acceptance of transition • Verify that all project-related tests are conducted according to the project quality plan and in compli-ance with IGM requirements. • Perform quality reviews for audit readiness, identify and document all project observations, gaps and risk with associated mitigation strategies • Support the problem solving of project deviations/errors and provide quality guidance on GxP regula-tory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) • Schedule sessions with Project and Operations Team to drive mitigation actions on gaps and risks • Ensure Acceptance Meetings, Knowledge Transfer and Asset identification for project transition |
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Verwendete Technologie |
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05/2015 - 08/2015 Dauer 4 Monate |
Rolle IT Project Manager/ Business Technology Analyst |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben IT-Governance, Qualitätsmanagement / QS / QA (IT), Risikomanagement, Transition Management, Transformation Management |
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Verwendete Technologie Projektmanagement (IT) Testdesign (IT) Migration Testmanagement / Testkoordination (IT) Dokumentation (IT) Business Analyse |
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12/2014 - 07/2015 Dauer 8 Monate |
Rolle Senior IT Business Analyst Logistics & Manufacturing |
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Branche Life Sciences |
Einsatzort Stein |
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Aufgaben ArtBase is Documentum D2 based system which supports review, approval and retrieval of artworks for printed packaging materials for Novartis Pharma. The system is used by 800 users worldwide. The Business Analyst role includes the following major accountabilities: - Design of Test Cases (PQ Testing) ensuring coverage of user requirements - Authoring of Test Specifications - Coordinate Test Execution with Subject Matter Experts - Prepare and Conduct pre-go-live and post-go-live/hypercare sessions taylored for the different end user groups. |
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Verwendete Technologie Incident Management IT Service Management (ITSM) SAP PP Pharmazie SAP EWM Requirement Analyse Manufacturing execution system (MES) Business Analyse |
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10/2014 - 12/2014 Dauer 3 Monate |
Rolle Business Process Analyst MRP II Business Excellence |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben Projektmanagement (IT), Testmanagement / Testkoordination (IT), Testdesign (IT), Migration, Dokumentation (IT), Business Analyse |
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Verwendete Technologie SAP MM SAP MDG Prozessoptimierung Manufacturing resources planning (MRPII) Transformation Management Business Analyse Supply-Chain-Management (SCM) |
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05/2014 - 10/2014 Dauer 6 Monate |
Rolle Project Manager, Transformation Management, Offshoring India |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben • Managing incident, service request and change management processes for IT applications of the integrated IT warehousing, material flow and distribution system environment in PharmOps Switzerland (SAP WM (ERP), GISC Labeling and Material Movement Controller) • Support and demand management for the ‘SU Process and Logistics Services’ concerning application operations and projects (e.g. warehouse refurbishment, weighing & dispensing) • ‘Translating’ business and engineering requirements for IT suppliers to realize IT solutions via changes and projects |
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Verwendete Technologie SAP MDM Telekommunikation / Netzwerke (allg.) Prozess- / Workflow Schulung / Training (IT) IT-Beratung (allg.) Change Management Transformation Management Projektmanagement |
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10/2013 - 05/2014 Dauer 8 Monate |
Rolle Consultant Project Quality Manager |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben Incident Management, IT Service Management (ITSM), SAP EWM, SAP PP, Requirement Analyse, Manufacturing execution system (MES), Business Analyse, Pharmazie |
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Verwendete Technologie |
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05/2013 - 10/2013 Dauer 6 Monate |
Rolle Consultant SAP/ Data Migration & Supply Data Management |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben Business Process Analyst, Projekt zur Implementierung von SAP Master Data Governance in Pharma Supply Chain basierend auf MRP II Class A Business Excellence. |
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Verwendete Technologie |
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10/2012 - 05/2013 Dauer 8 Monate |
Rolle Consultant BPM/ Process & Change Management, Training |
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Branche Life Sciences |
Einsatzort Basel |
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Aufgaben SAP MDG, SAP MM, Prozessoptimierung, Manufacturing resources planning (MRPII), Transformation Management, Business Analyse, Supply-Chain-Management (SCM) |
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Verwendete Technologie Prozess- / Workflow Prozessoptimierung Change Management Transformation Management Business Analyse |
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02/2012 - 08/2012 Dauer 7 Monate |
Rolle PMO/Projektassistenz Business Transformation & Program Management |
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Branche Telekommunikation |
Einsatzort Bonn |
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Aufgaben Transition Management in an Offshoring Project, Change Management, Process Analysis & Development Transition of Master Data Management and Operational Sourcing from Basel/Switzerland to Hydera-bad/India in Pharma External Supply Organization • Business Process Analysis and Optimization, Gap Analysis • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance • Improvement of Standard Organization Procedures (SOP) including process flows • Change Management, Change Communication • Training Development, Training Coordination |
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Verwendete Technologie Change Management Transformation Management Projektmanagement |
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05/2010 - 05/2011 Dauer 13 Monate |
Rolle Redaktionsleitung, Freie TV-Redakteurin |
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Branche Medienbranche |
Einsatzort Köln |
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Aufgaben SAP MDM, Telekommunikation / Netzwerke (allg.), Schulung / Training (IT), Prozess- / Workflow, IT-Beratung (allg.), Change Management, Transformation Management, Projektmanagement |
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Verwendete Technologie |
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11/2009 - 02/2012 Dauer 28 Monate |
Rolle Freie Journalistin & Beraterin für PR/ Presse- und ßffentlichkeitsarbeit |
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Branche |
Einsatzort Köln |
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Aufgaben IT Project Quality Management, Change Control Excellence in Pharma, Computer System Validation CSV, GxP, GMP, Tollgate Review, Oracle Agile PLM, Project Librarian |
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Verwendete Technologie |
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01/2008 - 06/2008 Dauer 6 Monate |
Rolle Marketing- und Projekt Assistenz |
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Branche Medienbranche |
Einsatzort Essen |
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Aufgaben Keine Qualifikationen angegeben. |
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Verwendete Technologie |
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02/2006 - 01/2008 Dauer 24 Monate |
Rolle Assistenz der Geschäftsführung |
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Branche |
Einsatzort Düsseldorf |
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Aufgaben Co-ordination of activities between Data owners (Functional and Business), as well as development team and quality manager, to ensure documentation is delivered, approach is followed and quality of the data migration is achieved. provide the data migration strategy, and coordinate testing activities and ensure testing is delivered according to the standards of the project. |
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Verwendete Technologie |
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03/2005 - 02/2006 Dauer 12 Monate |
Rolle Assistenz des Abteilungsleiters |
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Branche Öl- und Gasindustrie |
Einsatzort Essen |
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Aufgaben Keine Qualifikationen angegeben. |
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Verwendete Technologie |
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03/2004 - 03/2005 Dauer 13 Monate |
Rolle Assistentin Leiter Corporate Communications |
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Branche Chemieindustrie |
Einsatzort Düsseldorf |
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Aufgaben BPM Business Process Management, Business Analysis, Change Management, Change Communication, Training, Workshops, Projektmanagement, SAP Data Management, SCM Supply Chain Management |
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Verwendete Technologie |
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09/2002 - 12/2003 Dauer 16 Monate |
Rolle Projektleiter Marketing, Konzepter |
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Branche |
Einsatzort Dortmund |
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Aufgaben Prozessoptimierung, Prozess- / Workflow, Change Management, Transformation Management, Business Analyse |
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Verwendete Technologie |
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Skills
Agile Entwicklung
Auditor
DIN ISO/IEC 27001
IT Sicherheit (allg.)
Medizintechnik
Pharmaindustrie
Projektleitung / Teamleitung (IT)
Qualitätsmanagement (allg.)
SAP (allg.)
Administration
Annex
Business Analyse
Change Management
CMS
Content Management
Controlling
CSV
Demand Management
Dokumentation (IT)
Exceed
Firmware
HP
HTML
Incident Management
Interim Management
IT Service Management (ITSM)
IT-Beratung (allg.)
IT-Governance
ITIL
Mac OS
Manufacturing execution system (MES)
Manufacturing resources planning (MRPII)
Marketing
Migration
MindManager
MMC
Oracle Agile PLM
Pharmazie
PMO
PowerPoint
Projektmanagement
Projektmanagement (IT)
Prozess- / Workflow
Prozessoptimierung
Qualitätsmanagement / QS / QA (IT)
Remedy
Reporting
Requirement Analyse
RIM
Risikomanagement
Salesforce
SAP EWM
SAP MDG
SAP MDM
SAP MM
SAP NetWeaver
SAP PP
SAP SCM
SAP WM
Schulung / Training (IT)
SCRUM
Server
Service Management
Six sigma
Sponsoring
Supply-Chain-Management (SCM)
Telekommunikation / Netzwerke (allg.)
Testdesign (IT)
Testmanagement / Testkoordination (IT)
Transformation Management
Transition Management
Typo3
User Experience
Windows
Wordpress
Sprachen
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Sprache Deutsch |
Einstufung Muttersprache |
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Sprache Englisch |
Einstufung Verhandlungssicher |
Ausbildung
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Abschlussjahr 2014 |
Ausbildung zum/zur Systemischer Business Coach (Uni of A. Sciences, DVCT) |
Ort University of ... |
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Abschlussjahr 2012 |
Ausbildung zum/zur Systemischer Change Berater & Organisationsentwickler |
Ort alwart institu... |
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Abschlussjahr 2010 |
Studiengang ebam Business Akademie für Medien, Kunst & Kultur |
Ort Köln |
Studienabschluss Music Business Manager |
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Abschlussjahr 2009 |
Studiengang Deutsches Institut für Publizistik |
Ort Hagen |
Studienabschluss Journalist für Pressestellen und Öffentlichkeitsarbeit |
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Abschlussjahr 2002 |
Ausbildung zum/zur Bürokauffrau |
Ort Hülpert & Co.... |
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Abschlussjahr 1999 |
Ausbildung zum/zur Abitur Wirtschaftswissenschaften |
Ort Unna |
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Zertifikate & Weiterbildungen
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Zertifikat/Weiterbildung PQM Project Quality Manager (GIS, GMP, CSV Pharma) |
Ausstellungsdatum November 2013 |
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Zertifikat/Weiterbildung SAP Supply Data Manager (Novartis Pharma) |
Ausstellungsdatum Juni 2013 |
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Zertifikat/Weiterbildung Projektmanagement |
Ausstellungsdatum September 2012 |
