Fachlicher Schwerpunkt dieses Freiberuflers

Quality & Compliance/ CSV/ Auditor and Business Analysis/ Requirement Engineering for Pharma & Medical Device

verfügbar ab
06.01.2020
verfügbar zu
50 %
davon vor Ort
40 %
PLZ-Gebiet, Land

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D9

Österreich

Schweiz

Einsatzort unbestimmt

Städte
Frankfurt
50 km
Berlin
20 km
Hamburg-Mitte
20 km
Basel
10 km
Zürich
10 km

Position

Kommentar

Digital Health Tech Compliance & Quality Management, IT Audit & IT Security Management, Business Analysis/ Requirements Engineering Specialist for Software Development of Medical Device Software and Computerized Systems with Coaching Change and Communication Management background and strong experience in global IT and Business Transformation Programs.

  • More than 18 years’ experience in global corporate positions and multi-cultural and multi-disciplinary projects and programs with extensive know-how and working experience in the regulated Life Science and Health Sector
  • Experience in managing near-shore and / or off-shore teams across multiple locations
  • Excellent writer, presenter, moderator and facilitator for global projects with large audience
  • Customer focused, motivation to exceed expectations and go the extra mile
  • Consulting Services:
    • o Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD/MDR)
    • o Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems (13485,
    • o Quality Risk Management (FMEA, ISO 14971)
    • o Software Validation and Verification (IEC 623304/82304, GAMP 5/ CSV)
    • o Information Security Management ISO 27001 (TÜV SÜD Training as Compliance Officer TÜV SÜD, Certification in 09.2019, Lead Auditor Certification planned for 02.2020)
    • o Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366)
    • o Business Process Modeling & Transformation, BPMN 2.0
    • o Digital and Mobile Solutions Development, Digital Health, Agile/Scrum, Design Thinking
    • o Change and Communication Management, Systemic Organizational Development
    • o Systemic Business Coaching (St. Galler Management Modell)

Projekte

01/2019 - 06/2019

6 Monate

R&D Laboratory Relocation BioSimiliar

Rolle
Quality & Compliance Manager/ Auditor for CSV
Kunde
Fresenius Kabi SwissBioSim
Einsatzort
Eysin
Projektinhalte
  • Quality Assurance for Computer System Validation of Laboratory Relocation and Integration of Global IT Systems for Document Management (eCTD, eTMF, CTM, eLN)
  • Auditing of Supplier of It Systems
  • Requirement Analysis and Engineering for URS
Kenntnisse

Computer System Validation

Software Lifecycle

Data Quality

Auditor

Data-Migration

Software Quality Assurance

agiles Projektmanagement

Requirement Analyse

Conception

Bio-Technologie

Produkte

Documentum D2

Good Laboratory Practice

Labware

01/2018 - 03/2019

1 Jahr 3 Monate

Medical Device Software/ System Development, Validation + Verification Framework for Digital Health Apps

Rolle
Quality Assurance CSV and Medical Device Software Validation
Kunde
Fresenius Digital Labs GmbH
Einsatzort
Berlin
Projektinhalte

Service Delivery and direct report to Managing Director Digital Lab for Software Development of Medical Device Software and Computerized Systems

Fresenius Kabi Digital Labs GmbH, Berlin

  • Conception and Realization of Software Development Framework for Digital and Mobile Solutions based on Scrum Metholodgy combining regulated Life Cycle Documentation of Medical Device Software Validation and Verification and Computer System Validation
  • Validation Strategy and Management for Digital Health Medical Apps
  • Validation Concept and Management for Software Validation of JIRA Confluence for usage as validated Project and Documentation Software within Digital Lab
  • Quality Management support to implement Quality Management System ISO 134585 and ISO 9001 into Digital Labs (QMS Handbook, Procedures, Internal Audits)
  • Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD)
  • Quality Risk Management (FMEA)
  • Software Validation and Verification (IEC 62304/82304, GAMP 5), Usability Testing
  • Training and Coaching in regards to Computer System Validation and Regulatory Compliance
  • Stakeholder Management within Fresenius Quality Community
Kenntnisse

Scrum

ISO13485

IEC 62304

Software Quality Assurance

Audit

ISO 27001

Produkte

Atlassian Confluence

Atlassian JIRA Agile

Usability Testing

Computer System Validation

Application Lifecycle Management

FMEA

01/2018 - 06/2018

6 Monate

Building a Global CSV Competence Center

Rolle
IT Quality and Compliance Strategy Consultant, Senior Business A
Einsatzort
worldwide
Projektinhalte
  • Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including im-plementation of CSV Knowledge Management and Quality Assurance Unit worlwide
  • Conception and Process Design of One Global IT Architecture Landscape for a validated Global Application Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
  • CSV/ Validation of ARIS BPM Tool to manage all business process/ system changes and validation doc-umentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
  • Conception and Realization of CSV Framework and QMS for the new Digital Lab of Frensenius (Digital Healthcare and Mobile and Medical Devices), implementing Confluence as validated Project and Documentation Software
  • CSV/ Validation of new implementation of Service Now Discovery
  • CSV/ Validation of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs in regrads to Data Integrity and ERES regulations
Kenntnisse

Computer System Validation

Business Process Analysis

Business Process Modeling Notation

Software Quality Assurance

GxP-Compliance

Application Lifecycle Management

RequirementEngineering

Knowledge Management

Change Management

Qualitäts Management

ISO 9001

GAMP

Produkte

ARIS Plattform

Atlassian Confluence

Documentum D2

SAP ERP

SAP SolMan

01/2016 - 12/2017

2 Jahre

Strategy Consultant Computer System Validation

Rolle
Global Quality Management, Global Quality and System Compliance
Kunde
Fresenius Kabi
Einsatzort
Bad Homburg, Germany
Projektinhalte
  • Giving Strategy and Advice to establish a Corporate Framework for Project Governance of Computer System Validation (risk-based approach GAMP5)
  • Ensure the Corporate Framework and corresponding Global Operating Procedures are  fully integrated into Fresenius Kabi Global IT Strategy
  • Ensure that computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their life-cycle
  • Support the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) as well as IT project related documents in line with Fresenius quality and regulatory requirements in the respective IT function.
  • Liaise effectively with Quality and IT personnel across Fresenius Kabi as well as other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems are in place, maintained and opportunities for continuous improvement identified and implemented
  • Support the development and delivery of training relevant for Quality, IT and business functions in the area of computerized systems compliance

Global IT Programs: eDMS, SAP, MES, TRACKWISE, Complaint Handling Tool

Kenntnisse

GxP-Compliance

Audit

Application Lifecycle Management

Qualitätsicherung

Knowledge Management

Complaint Management

Computer System Validation

Business Reporting

Produkte

Documentum D2

Werum IT Solutions

10/2015 - 12/2015

3 Monate

IT Quality and Compliance Manager with focus on IT Transition, Information Governance and Risk Management

Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Ensuring that the transition projects and applications are managed in compliance with IGM requirements, 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, developing document management and archiving concept for all audit relevant documents
  • Verify that all project-related tests are conducted according to the project quality plan and in compliance 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 and quality risk and provide quality guidance on GxP regulatory 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

12/2014 - 10/2015

11 Monate

Senior IT Business Analyst with focus on Manufacturing and Logistics, IT Service Management

Rolle
Interim Management at Local IT, Manufacturing and Logistics
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Managing Service Delivery Management: incident, service request and change management processes for IT applications of the integrated IT warehousing, material flow and distribution system environment in PharmOps Switzerland (MES, 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 
  • Development of MS SharePoint Site for Document Management and Knowledge Base for Key Users, delivered Workshops, Trainings and Onboarding Strategy

05/2015 - 09/2015

5 Monate

Senior IT Business Analyst with focus on Requirements Engineering and Test Management

Rolle
Document Management Software Project, Artwork Operations
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Global Implementation of Documentum D2 for Document Management of Regulatory Artworks
  • Identify and create Business User Requirements within Workshops with Key Users to design the expected IT Solution
  • 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 of 800 users worldwide 

05/2014 - 12/2014

8 Monate

Business Transformation and Transition Project, Supply Chain Excellence, MRP II Class A

Rolle
Project Manager with focus on Change and Communication Managemen
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
  • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis, Gap Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Stakeholder Management
  • Change Management, Change Communication 
  • Training Development, Training Coordination 
  • Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyderabad/India in Pharma External Supply Organization
  • Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to establish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, audited by Oliver Wright Company
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports,  risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis, Gap Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Stakeholder Management
  • Change Management, Change Communication 
  • Training Development, Training Coordination 

Achievements:  

  • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 

  • Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing) 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders 

10/2013 - 04/2014

7 Monate

Change Control Project with Oracle Agile integration, Global Technical Operations, Supply Chain

Rolle
Project Quality Manager Computer System Validation, Document Man
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Implementation of an integrated system based on Oracle Agile PLM to change control and support product information management of regulatory relevant information for Pharma 
  • Preparation of key Computerized System Validation documents, such as Validation Plan and Validation Report, conducting Quality Risk Assessment
  • Coordination of the preparation of documents by adequate stakeholders 
  • Management of the review, approval and implementation process of project deliverables 
  • Definition of the Tollgate Report, tracking of Tollgate deliverables 

Achievements:  

  • Delivered Validation Strategy 
  • Delivered compliant system, no incidents 
  • Improved Project Documentation Management by implementing new concept for document archiving and approval process including Training for all writers and users 

05/2013 - 10/2013

6 Monate

SAP Data Migration Project, Supply Chain Management

Rolle
IT Business Analyst, SAP Data Migration Manager
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Integration of API Drug Substance and SRM Strategic Raw Material business in one single SAP plant for Multimarket business and Switzerland in Pharma Supply Chain 
  • Development of the data migration methodology & implementation plan 
  • Development of best practice, processes and standards for effectively carrying out data migration activities 
  • Analysis, cleansing, harmonization and migration of data 
  • Coordination of testing activities 
  • Change Management, Change Communication 
  • Training Development, Training Coordination 

Achievements:  

  • Delivered Migration and Cutover Strategy 
  • Assessed and delivered clean and proper Data for data migration activities 

12/2012 - 04/2013

5 Monate

Business Transformation Project with SAP SCM integration, Supply Chain Management

Rolle
Project Manager Change and Communication Management, Business Pr
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Establishment of Master Data Organization in External Supply Chain Management 
  • Establishment of Supply Data Manager job role 
  • Integration of MDM Team to ESO Organization 
  • Business and IT Process Analysis and Optimization 
  • Improvement of Standard Organization Procedures including process flows 
  • Training Development, Training Coordination  
  • Change Management, Change Communication 

Achievements:  

  • Drive the organizational Change in Master Data Organization and make sure the functional solution fits to the global and local structures 
  • Delivered Change and Communication Strategy including Stakeholder Management 
  • Delivered Workshops and Trainings for users and stakeholders 

09/2012 - 11/2012

3 Monate

SAP – New Plant Implementation Project, Supply Chain Management

Rolle
Project Manager Supply Master Data Management, Business Process
Kunde
Novartis AG
Einsatzort
Basel, Switzerland
Projektinhalte
  • Implementation of a new SAP plant to concentrate all business operations for multimarket and European external supply activities in Pharma External Supply Organization 
  • Leading the Workstream for Master Data Management
  • Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports, risk plan including targets, milestones, resources, cost, expenses
  • Business Process Analysis and Optimization 
  • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance 
  • Change Management, Change Communication 
  • Training Management, Training Coordination 

Achievements:  

  • Developed of Master Data Maintenance Strategy for Material, Vendor and Quality Master Data 
  • Delivered Concept for Master Data Governance 

08/2007 - 08/2012

5 Jahre 1 Monat

Various Projects & Clients

Rolle
Corporate Communication Manager, Public Relations Officer
Kunde
Agency for Corporate Communication and Strategy, Corporate Branding, Public and Social Media Relations, Digital Marketing and Design
Einsatzort
Cologne, Germany
Projektinhalte
  • Consulting for Strategy, Conception, Campaigning, Branding, Public Relations, Online & Social Media Relations, Digital Marketing, Corporate and Web Design 
  • Social Media Management, Content Management, Journalism, Editorials 
  • Event Management, Incentives 
  • Art & Culture Management, Bookings and Promotion 

Achievements:  

  • Developed Communication and Marketing strategies, that foster innovation in the digital space by adding cross-domain, cross-functional expertise on technology and business trends 
  • Reference Project: Developing and implement “VERSA” as digital avatar for VERSATEL to enforce Customer Relationship and Online Reputation Management on twitter, Facebook and diverse online forums (First Online Avatar in Germany) 

02/2012 - 07/2012

6 Monate

Various Projects

Rolle
PMO Lead
Kunde
Deutsche Telekom AG
Einsatzort
Bonn, Germany
Projektinhalte
  • PMO/Project Management Officer to Program Manager Product Design & Innovations, Telekom Innovation Labs, Virtualized Infrastructure & Global Cloud IT, User Experience Design 
  • Project Management for Design Transformation and Global Talent Management, Change Management, Change Communication, Concepts & Text, Design Thinking, Agile/Scrum 

Achievements:  

  • Improve Talent Management Strategy to hire worldwide the most talented Designers for Deutsche Telekom Product Design 

05/2010 - 05/2011

1 Jahr 1 Monat

Various TV Projects

Rolle
Chief Editor/ TV-Journalism & TV-Production
Kunde
RTL Television
Einsatzort
Cologne, Germany
Projektinhalte
  • TV Editorial, TV Production, Television reports, features, magazines, RTL Punkt 12, RTL exklusiv, VOX prominent  

Achievements:  

  • Developed TV-Production concept and editorial for TV-Features with ViPs like Topmodel Franziska Knuppe, Fashion Designer Talbot & Runhof and Guido Maria Kretschmar 

01/2007 - 07/2007

7 Monate

Various Projects

Rolle
Project Manager – Online and Digital Marketing
Kunde
Virtual Nights Media Ltd
Einsatzort
Essen, Germany
Projektinhalte
  • Online Editorials, Internet/Intranet Content Management (TYPO 3, JOOMLA), CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

Achievements 

  • Developed Sponsoring and Communication Concept for Love Parade Dortmund and other international Events and Festivals 
  • Developed new Micro-Website for Customer Services in TYPO 3 

06/2006 - 12/2006

7 Monate

Various Projects

Kunde
Movie Art Marketing
Einsatzort
Dortmund, Germany
Projektinhalte
  • Project Management, Event Management, Incentives, Sponsoring, Product Placement in TV and Cinema movie productions, Online Editorials, Internet/Intranet Content Management, CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding 

Achievements:  

  • Increase the sells for Sponsoring and Customer Events over a 35 % during my procedure 
  • Delivered Marketing Strategy for Charity Golf Event of Deutsche Post and Kamps 

Projekthistorie

Operations/Permanent Positions, 2002 – 2006 

 

Junior Project Manager – Marketing and Events 

Various Corporate Communication & Branding, Public Relations Projects 

Evonik AG, Düsseldorf, Germany 

  • Personal Assistant to Head of Corporate Communications and Head of Public Relations, Junior Project Manager for global Projects in Corporate Communications & Branding, Public Relations 

 

Management Assistant 

Quality Management, Ecology 

Deloitte Touche Tohmatsu, Düsseldorf, Germany 

  • Personal Assistant to Head of Extra Financial Issues, Quality Management, Ecology, Emission Trading, Corporate Social Responsibility, Public Relations, Internet/Intranet Content Management, international Event- and Fair planning and organization 

 

Management Assistant 

Ecology, Energy Management 

RWE, Essen, Germany 

  • Personal Assistant to Head of Ecology, Energy Management, Ecology, Emission Trading, Corporate Social Responsibility, Quality Management, Power Plant Development 

 

 

Project Assistant 

Finance & Controlling 

RWE, Essen, Germany 

  • Project Assistant to Vice President Finance & Controlling, Development of Financial Reporting, Medium-term Financial Planning, Interim Assistant 

 

Management Assistant 

Logistics 

VTE Lehnkering AG, Düsseldorf, Germany 

  • Personal Assistant to Vice President Logistics, Interim Assistant 

 

 

Management Assistant 

Customer Service Management

VW/Audi Autohaus, Hülpert, Dortmund, Germany 

  • Personal Assistant to Head of Customer Service Management 

Kompetenzen

Produkte / Standards / Erfahrungen
Application Lifecycle Management
ARIS Plattform
Atlassian Confluence
Atlassian JIRA Agile
Bio-Technologie
Business Process Analysis
Change Management
Complaint Management
Documentum D2
Good Laboratory Practice
ISO 27001
Knowledge Management
Labware
RequirementEngineering
SAP ERP
SAP SolMan
Werum IT Solutions

Primary Expertise

  • Information Governance/ Quality Risk Management
  • CSV Computer System Validation
  • Supply Chain Management Processes
  • MRP II Class A/ Oliver Wright Company
  • Manufacturing and Logistic IT Systems
  • Novartis ICE Project Management (LEAN, Six Sigma)
  • Novartis IT and ERP Project Management (PMI)
  • 21CFR Part 11 and Annex 11
  • GLP, GCP, cGMP, GAMP5
  • ISO IDMP, eCTD
  • ITIL V3 Foundation

Related Experience

  • Project and Quality Management
  • Business and IT Transformation
  • ITIL Service Transition
  • Business Process Modelling and Engineering
  • Change and Communication Management/ Training and Coaching
  • Document and Content Management
  • Master Data Governance, Data and Migration Management
  • Good Documentation and Writing Skills (CSV/ GxP Requirements, SOPs, Handbooks, Manuals etc.)
  •  Project and Quality Management
  • Business and IT Transformation
  • ITIL Service Transition
  • Business Process Modelling and Engineering
  • Change and Communication Management/ Training and Coaching
  • Document and Content Management
  • Master Data Governance, Data and Migration Management
  • Good Documentation and Writing Skills (CSV/ GxP Requirements, SOPs, Handbooks, Manuals etc.)

Industry Standards and Methods

  • ISO (ISO-9000 and 14971),  GAMP5

Regulations

  • ICH, FDA, WHO, EMA
  • Annex/Part 11, predicate GLP, GCP, GMP rules
  • ISO IDMP, eCTD

Office Applications

  • MS Office (Excel, Word, PowerPoint, SharePoint, Visio, Project), Outlook, SharePoint
  • Mac iWork, Mac Mail
  • IBM Lotus Notes

 

 


Sprachkenntnisse
English
business fluent
German
native

Managementerfahrung in Unternehmen
Auditor
Computer System Validation
GxP-Compliance
Qualitätsicherung
Software Lifecycle
Software Quality Assurance

Interim Management and Leadership

  • Quality and Compliance Manager
  • Change and Transformation Manager
  • IT Project Manager, Business Analyst/ Engineer

Hardware

Business Software, Hardware, Firmware

  • ITSM IT Service Management – BMC Remedy ITSM Suite, SAP NetWeaver
  • ERP – SAP SCM, MM-PUR, WM, PP, Procurement (Material Management) incl. all objects: BOM, PR, SL, Contract and Purchase Order, Order Fulfillment (Sales Order Management), Vendor Master Data (including SIM Tool authorization), Quality Master Data, R/3 HR, ESS
  • SAP Hana Cloud (Application for Digital Home & Healthcare)
  • MES Manufacturing Execution Systems (ATLAS, PAS-X, PMX), MMC Material Movement Controller
  • CMS Content Management – Vignette, Microsoft Office SharePoint Server (ECM), MODx, TYPO3, Wordpress, HTML
  • Document Management - Documentum D2, Veeva, Microsoft SharePoint
  • CRM Customer Relationship Management – Mamis (Deloitte), vtiger, Daylite, salesforce
  • Project Management - Microsoft Project, Biquanda (ehem. OpenTime), Open Workbench, Sciforma, Project Scheduler, GRANEDA Dynamic, GANTT project, MindManager
  • Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
  • BPM Business Process Modelling – ARIS
  • JD Edwards One World

Programmiersprachen
Business Process Modeling Notation

Aufgabenbereiche
Audit
Business Reporting
Digital Health Software
IEC 62304
ISO13485
Scrum
Usability Testing

Design / Entwicklung / Konstruktion
agiles Projektmanagement
Conception
Data Quality
Data-Migration
FMEA
Requirement Analyse

Ausbildungshistorie

Donau Univerity Krems, Master of Science: Infromation Technology in Healthcare (2019 - 2021)

SRH Hochschule Heidelberg, Bachelor of Science - BS, Clinical Psychology · (2018 - 2021)

Johner Institute, Medical Device Software Development (IEC 62304, FDA), Computer Software Engineering · (2018 - 2018')

Johner Institute, Human Factors/ Usability Engineering (IEC 62366, IEC 60601, ISO 14971, FDA), Computer Software Engineering · (2018 - 2018)

Johner Institute, Risk Management for Medical Devices (ISO 14971), Biomedical/Medical Engineering · (2018 - 2018)

Schweizerische Gesellschaft für Organisation und Management SGO, Resilience Engineering/ Human Factors & Human-Machine Interaction (ISO 31000), Industrial and Organizational Psychology · (2018 - 2018)

  • eREGULATORY AND INTELLIGENCE/ ISO IDMP, Drug Information Association DIA, Philadelphia/US (06/2015)
  • SYSTEMIC BUSINESS COACHING/ St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar (02/2014)
  • CERT. PROJECT QUALITY MANAGER, IT-Project Management & Computer System Validation in pharmaceutical industries, Novartis (11/2013)
  • SAP DATA MIGRATION MANAGER (Novartis Project Role to implement API Business) (2013)
  • SUPPLY DATA MANAGER SAP SCM/ Supply Chain Data Management in pharmaceutical industries, Novartis (02/2013)
  • OPERATIONAL SOURCING MANAGER SAP SCM/ Contract & Price Management in pharmaceutical industries, Novartis (06/2014)
  • CERT. SYSTEMIC CONSULTANT/ AGENT FOR CHANGE MANAGEMENT & ORGANIZATIONAL DEVELOPMENT Alwart institute, Hamburg (02/2013)
  • JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT, German Institute for Publicity & Journalism, Hagen (09/2008)
  • MANAGEMENT ASSISTANT BUSINESS ADMINISTRATION Apprenticeship, Volkswagen/Audi, Dortmund (06/2002)
  • DIPLOMA IN BUSINESS ADMINISTRATION, Commercial High School, Unna (06/1999)

 

Certificates in Pharma

  • Novartis ICE/ IQP Project Management (LEAN, Six Sigma Methodology)
  • Novartis IGM IT & ERP Project Management (PMI)
  • Novartis CSV Computer System Validation
  • Working Across Cultures: India (Novartis)