Education

• Electronics, University of Erlangen, Germany (Master)
• Computer science, subsidiary subject medicine, University of Erlangen, Germany (Master)

Positions

• Auditor
• Compliance manager
• Interims manager, program manager, multi project manager, coach (Project responsibility up to 80 members/50 Mio. EUR Budget)
• Risk manager
• Service manager

Focus

• Audit
• Compliance (COBIT, COSO, EUDRALEX, FAA, FDA, GxP, GAMP, Information Asset Protection, ISAE3402, Privacy, SAS70, Security, SOX, SSAE16)
• Quality & test management
• Service management ITIL (V1..V3)
• Business process engineering
• Strong business (Financial management) background

Languages

• English Business fluent
• French Common speech
• GermanMother language
• Italian Common speech
• Russian Beginner level

GxP Fields of experience:

• Audits
  • o FDA Audits (preparation for audits, audit supervision, primary contact)
  • o Internal audits (coaching during audit, audit leadership)
  • o TÜV & DEKRA Audits (preparation for audits, audit supervision, primary contact)
  • o Vendor assessments, audits (questionnaire, on-site), assessments
  • o Preparation of 510k PMA requests
• Calibration and Calibration management
• CAPA/Complaint & Deviation management
• IDMP
  • o GINAS
  • o HUB (connectivity to authorities)
  • o SPOR
  • o Master data management in general
• Labeling (Oracle Healthcare Suite, Proprietary)
• LIMS
• Medical devices
  • o CMF
  • o Power tools
  • o Spine
  • o Trauma
• Medical equipment
  • o Controlled negative pressure pumps
  • o ECG
  • o Hemodynamic monitoring
  • o MRT
  • o Ultra sonic systems
  • o Venous oxygen saturation measurement systems
• Microbiology
  • o Aseptic processing
  • o Clean room management
• Pharmaceutical
  • o Biotechnology
  • o Drugs
  • o Filling and finishing
  • o Labeling
  • o Liquids
  • o Logistics (warehousing, storage)
  • o Packaging
  • o Production
• Quality systems
  • o ISO 9001
  • o ISO 10006
  • o ISO 13485
  • o ISO 14675
  • o ISO 60601
  • o ISO 62133
  • o ISO 62304
  • o Proprietary ones
• Qualification, Validation, Verification
  • o 510k Qualification
  • o Biocompatibility qualification
  • o CE (with notified body) qualification
  • o Computerized systems (qualification, validation)
  • o Equipment (qualification, validation)
  • o Method (qualification, validation)
  • o Process (qualification, validation, verification)
• Serialization
  • o End to End
  • o EPCIS
  • o GS1
  • o HDA
  • o SAP OER
  • o Track and Trace
• Testing (FAT, SAT, preparation for tests, test execution)

Memberships

• ISACA (Information System Audit and Control Association, www.isace.org ), GxP working group
• ISPE (International Society of Pharmaceutical Engineers, www.ispe.org )
• PHSS (Pharmaceutical & Healthcare Science Society, www.phss.co.uk )

Highlights

• More than 30 years experience as an international project & program manager
• More than 25 years experience in the pharmaceutical and medical device industry
• More than 20 years experience with ITIL projects (V1..V3)
• More than 15 years experience with GAMP, GxP ISO13485, 21CFRxxxx, ISO6060x, 62304, 62133 in the medical and pharmaceutical area
• More than 10 years experience with SOX, COBIT, SAS70, SEC01/02/03, SSAE16, ISAE3402, COSO and other control frameworks

Regulations & Standards

• 21CFRxxxx (especially part 11, part 807, part 820, part 821)
• Agile (Scrum) development & project management
• Bio compatibility
• BSI Grundschutz
• CMDR (Canadian Medical Device Regulations)
• CMM (Capability Maturity Model), CMMI
• COBIT 4, 5 (Control Objectives for Information and Related Technology)
• COSO (Committee of Sponsoring Organizations of the Treadway Commission)
• DevOPS (Development & Operations Collaboration)
• DITA (Darwin Information Typing Architecture)
• DO 178 B/C, DO 254 (FAA Standards)
• EUDRALEX (especially volume 4, annex 11)
• FAA (Federal Aviation Administration, US)
• FDA (Food & Drug Administration, US)
• FMD
• GAMP3, GAMP4, GAMP5
• GS1
• HDA
• ICH-Q (International Conference on Harmonization of Quality)
• ISAE3402 (International Standards for Assurance Engagements)
• ISO
  • 900x
  • 10006
  • 13485
  • 14971
  • 20000
  • 21500
  • 22307
  • 27xxx
  • 60601
  • 62133
  • 62304
• IREB (International Requirements Engineering Board)
• ITIL (V1, V2, V3, V3 2011) (IT Infrastructure Library)
• OOA, OOD (Booch, CoadYourdan, Rumbaugh)
• PMI (Projekt Management Institut)/ GPM (Gesellschaft für Projekt Management)
• Prince 2
• RUP (Rational Unified Prozess)
• Sarbanes Oxley Act (SOX), SOX404
• SAS70 (Statement on Auditing Standards)
• SOC1, 2, 3 (Service Organization Controls)
• SSAE16 (International Standards for Assurance Engagements)
• UML (Unified Modeling Language) (incl. extensions)
• V-Modell

Projects

• Time period 08/2017 ? today
• Company/Branch Fresenius/ Pharmacy
• Project Serialization worldwide (End-to-End and Track and Trace)
• Role(s)
  • Project manager
  • Mentor & coach
  • Auditor for provider
  • Coach for provider
• Tools/Standards
  • GS1, HDA, SAP OER/SNMS, SAP PO, Tracelink, EPCIS, FMD
• Sub projects/Tasks
  • Supplier audits and management
  • Project management
  • Mentoring production sites
  • Mentoring Market units
  • Mentoring master data management
  • Preparation of lifecycle documents (VP, URS, RA, TM, FS, VR, ..)
  • Complaints management
  • Serialization process modeling
  • Validation of serialization systems incl. packaging lines
  • Mentoring of provider in quality and security management

• Time period 02/2017 ? 07/2017
• Company/Branch ING DiBa/Bank
• Project SOX & KCT Audit Preparation (CSA1, CSA2, external audit)
• Role(s)
  • Program manager
  • Mentor & coach
  • Quality consultant
• Tools/Standards
  • SOX404, SAS70, COSO, COBIT, Jira, MS Project, Service Now
• Sub projects/Tasks
  • Project/Program management
  • Resource management
  • Budget management
  • Mentoring in the security area (change mgmt., platform security, IT resilience, security monitoring, identity & access mgmt., ..)
  • Mentoring SOX & non-SOX Test script preparation
  • Mentoring Process House & ITIL Process Modeling
  • Mentoring Change Management Process
  • Mentoring in Data Integrity (ALCOA)
  • Mentoring in IAM
  • Mentoring Platform Security
  • Mentoring in Secure Code Review
  • Mentoring Security Incident Processing
  • Mentoring Security Monitoring
  • Mentoring License Monitoring and Management

• Time period 07/2016 ? 12/2016
• Company/Branch Boehringer/Pharmacy
• Project IDMP GINAS &RAMP
• Role(s)
  • System Lead GINAS
  • System Lead RAMP (information hub & bridge)
  • Quality consultant
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, ISO IDMP, EMA IDMP, FDA IDMP, SPOR, SRS, Insight, Informatica PowerCenter, Designer, Database, SAP PO & PI Messaging Interface
• Sub projects/Tasks
  • Project management
  • Stakeholder management
  • Validation management
  • Application consultant
  • Architecture review
  • Business process analysis and modeling
  • Mentoring master data management (consolidation, data exchange, referencing)
  • Product and service provider market analysis
  • Contract (with 3rd party service provider) review & negotiations
  • Product resp. service evaluation
  • Business continuity analysis for substance management and data starting and messaging system/application
  • Supplier assessments
  • Modeling specific Governance & Compliance and Support Processes

• Time period 10/2015 ? 11/2016
• Company/Branch Boehringer/Pharmacy
• Project BIgCal Worldwide Calibration Management

Role(s)

• Application validation manager (Beamex CMX)
• Quality consultant
• Application consultant
• Tools/Standards
• 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, Calibration standards
• Sub projects/Tasks
  • Application consultant
  • Complaints management
  • CAPA & Deviation management
  • Contract (with service provider) review & negotiations
  • Labeling of equipment
  • Validation management
  • Modeling Operations and Support Processes

• Time period 07/2016 ? 11/2016
• Company/Branch Novartis/Pharmacy
• Project MABS
• Role(s)
  • Automation Engineer Lead
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards, OSIsoft PI, SCADA, PCS7, PS7, LIMS

Sub projects/Tasks

• Quality Management
• Document Review
• Supplier Management
• Data processing from various LIMS
• Coaching business continuity planning and implementation for data historian system/application

• Time period 07/2016 ? today
• Company/Branch Boehringer/Chemicals
• Project Chemicals
• Role(s)
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards, OSIsoft PI, SCADA, PANDA
• Sub projects/Tasks
  • CAPA & Deviation management
  • Quality Management
  • Technical Coach

• Time period 04/2016 ? today
• Company/Branch Boehringer/Pharmacy
• Project Respimat
• Role(s)
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards, OSIsoft PI, SCADA
• Sub projects/Tasks
  • CAPA & Deviation management
  • Quality Management

• Time period 07/2015 ? 12/2016
• Company/Branch Boehringer/Pharmacy
• Project Quality & compliance projects GQS
• Role(s)
  • Application validation consultant (ARIS, Relics, IT Shop, PaRes, PlantAccess, SAP SolMan, SAP QM, StorageGateway, UC4)
  • Business CSV Engineer
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards
• Sub projects/Tasks
  • Assessment of compliance documents for various projects
  • CAPA & Deviation management
  • Major incident management
  • Mentoring SOP creation & review
  • Mentoring SURF remediation
  • Periodic review management
  • Quality Management

• Time period 03/2015 ? 12/2016
• Company/Branch Boehringer/Pharmacy
• Project Quality & compliance projects GQC
• Role(s)
  • Infrastructure CSV Engineer
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards, SAP QM
• Sub projects/Tasks
  • Assessment of compliance documents for various projects
  • FDA Audit preparation and mentoring
  • FDA readyness
  • CAPA & Deviation management
  • Labeling of pharmaceutical products, primary and secondary packages)
  • Mentoring SOP creation & review
  • Periodic review management
  • TÜV Audit preparation & mentoring (ISO 900x, 14971), acting as lead contact for audits
  • Quality Management
  • Preparation of a quality handbook according to (ISO 900x, 14675)
  • Mentoring Serialization, Packaging, Labeling and Transportation in Greece

• Time period 01/2015 ? 03/2015
• Company/Branch Lohmann & Rauscher/Medical devices
• Project Controlled negative pressure wound pumps CE application preparation
• Role(s)
  • CSV Engineer
  • Risk manager
  • Quality manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, ISO 14971, 60601, 62133, 62304
• Sub projects/Tasks
  • CAPA & Deviation management
  • Consulting in service management (ITIL)
  • Consulting & mentoring in requirements management and specification documents
  • Labeling of medical devices
  • Preparation of risk assessment according to 60601, 62133, 62304
  • Preparation of hierarchical risk assessment document layouts
  • Modeling Governance & Compliance and Quality Processes
  • Mentoring in quality management

• Time period 11/2014
• Company/Branch Terumo/Medical devices
• Project Internal audit
• Role(s)
  • Auditor
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, LIMS
• Sub projects/Tasks
  • Internal audit on site

• Time period 08/2014 ? 01/2015
• Company/Branch Boehringer/Pharmacy
• Project PIMS02, Respimat LPS
  • Role(s)
  • CSV Engineer
  • Equipment qualification consultant
  • Method compliance consultant
  • Process compliance consultant
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, proprietary tools & standards
• Sub projects/Tasks
  • Assessment of compliance documents for various projects
  • CAPA & Deviation management
  • Execution of provider audits
  • Preparation of guidelines for provider audits (questionnaire, strategy, on-site)
  • Review & release of process compliance documents (process design, process controls, qualification, validation, verification, critical quality attributes, critical process parameters, continuous improvement, gap analysis, mitigation plans, deviations,..)
  • Labeling of pharmaceutical products, (primary and secondary packages)
  • Mentoring equipment validation (filler, finisher)
  • Mentoring method validation
  • Mentoring agile development & project management
  • Quality Management

• Time period 07/2013 ? 12/2014
• Company/Branch Boehringer/Pharmacy
• Project Audit, quality & compliance projects GQC
• Role(s)
  • Auditor, audit consultant (internal, FDA, TÜV)
  • CSV Engineer
  • Quality Manager
• Tools/Standards
  • 21CFRxxxx, EUDRALEX, GxP, GAMP5, ICH-Q, SAP document management, TPI, HP Quality Center, proprietary tools & standards
• Sub projects/Tasks
  • Assessment of compliance documents for various projects
  • CAPA & Deviation management
  • FDA Audit preparation and mentoring
  • Preparation of guidelines for provider audits (questionnaire, strategy, on-site)
  • Review & release of process compliance documents (process design, process controls, qualification, validation, verification, critical quality attributes, critical process parameters, continuous improvement, gap analysis, mitigation plans, deviations,..)
  • Labeling of pharmaceutical products, (primary and secondary packages)
  • Mentoring SOP creation & review
  • Coaching the department for site wide business continuity analysis, planning, implementation and testing
  • Periodic review management
  • Quality Management

• Time period 03/2013 ? 08/2013
• Company/Branch JnJ DepuySynthes/Medical devices manufacturer
• Project Global remediation quality project 
• Role(s)
  • Auditor
  • CAPA Consultant
  • CSV Consultant
  • Equipment Validation & Verification Consultant
  • Method compliance consultant
  • Process compliance consultant
  • SOX compliance consultant
• Tools/Standards
  • Trackwise, ETQ, LIMS, HP Service Manager, HP Quality Center, Lotus Notes, ITIL, Oracle Healthcare Suite, SAP MM, PP
• Sub projects/Tasks
  • Preparation of legacy reviews
  • Preparation of compliance analysis documents (areas: GxP, privacy, security, information asset protection, records management, CFR21 part11, part 820, ..)
  • Preparation of an inventory of GxP relevant applications & systems
  • Preparation of all lifecycle relevant documents (USR, FS, DS, UAT, risk analysis, traceability matrix, ..)
  • Execution of supplier & provider audits
  • Labeling of medical devices and packages
  • Mentoring Serialization, Packaging, Labeling and Transportation in Salzburg/Austria
  • Mentoring SAP Validation
  • Design of data connection from LIMS to Oracle Healthcare Suite
  • Mentoring equipment validation (complex optical instruments, complex measurement instruments)
  • Mentoring method validation (cleaning, sterilization)
  • Coaching agile development & project management
  • Coaching business continuity and availability management
  • Requirements management
  • Risk management
  • Coaching process compliance
  • Mentoring SOP creation
  • Preparation of process compliance templates & documents (process design, process controls, qualification, validation, verification, critical quality attributes, critical process parameters, continuous improvement, gap analysis, mitigation plans, deviations,..)
  • Coaching CAPA Remediation
  • CAPA & Deviation management
  • Mentoring SOX Compliance
  • Coaching method compliance validation
  • Coaching 510k permit approval request preparation

• Time period 10/2012 ? 02/2013
• Company/Branch Hewlett Packard &Johnson&Johnson/service provider & MDD
• Project Audit Remediation
  • Role(s)
  • Auditor
  • Coach
  • Mentor
• Tools/Standards
  • MS Project, FMEA, GxP, GAMP5, 21 CFR 11, FDA, DITA, Enterprise Architecture Management Frameworks, TOGAF, Zachmann, HP Service Manager 7 & 9, ISAE3402, SSAE16, SOC3
  • Sub projects/Tasks
  • Project planning
  • Quality management review (gap analysis, document review)
  • SAP Application analysis & disaster recovery enabling
  • SAP Disaster recovery dress rehearsals, desktop exercise design & mentoring
  • SAP Change management process design and documentation, workshops configuration management
  • Risk management process design and documentation, risk assessment documentation, workshops, risk mitigation planning
  • Physical security management process design and documentation
  • Access management process design and documentation
  • Coaching business continuity planning and implementation for pay roll system
  • User & account management process design and documentation
  • database management process design and documentation
  • Enterprise Architecture Modeling
  • ITIL Process Modeling

• Time period 05/2012 ? 09/2012
• Company/Branch Novartis CH/Pharmacy
• Project Quality Management
• Role(s)
  • Coach & mentor
  • Internal auditor
  • Quality manager
  • Supplier & vendor auditor
• Tools/Standards
  • MS Project, ICE, IGM, GxP, GAMP3, GAMP5, 21 CFR 11, FDA, DITA, Enterprise Management Frameworks, TOGAF, Zachmann, Clarity, LotusNotes, ITIL V3/2011, HP Service Manager 7, Trackwise
  • Sub projects/Tasks
  • Project management
  • Quality management
  • Coaching and mentoring of the whole department in QM context
  • Control of the standard operating procedures and work instructions for the AQWA (tool for all compliance activities)
  • Service Desk (Lotus Notes bases proprietary solution) coaching
  • Supervision and management building a knowledge base related to known bugs, known issues and corresponding corrective actions and maintaining that knowledge base
  • Supervision and management of the preparation of scripts basing on that knowledge base and the corrective actions in the area of service management
  • Preparation of a documentation plan
  • Preparation of a document management concept
  • Preparation of templates for every document type (SLA, operations-handbook, quality management handbook, validation handbook, traceability matrix, process descriptions, test plans, test-case Specification, functional specification, design specification, risk assessment, risk register, ..)
  • Coaching and monitoring the writing of documents (incl. SOPs)
  • Label management
  • Running internal documentation audits (reviews, gap analysis, remediation)
  • Design of data connection from LIMS to Trachwise
  • Running vendor audits
  • Coaching CAPA management
  • Coaching complaint management
  • Coaching business continuity planning and implementation for Trackwise platform
  • Definition of change configuration and release management process
  • Coaching & mentoring of internal and external audits

• Time period 11/2011 - 05/2012
• Company/Branch Hewlett Packard/EON
• Project Inventory Management
• Role(s)
  • Project manager
  • Consultant
• Tools/Standards
  • MS Project, ITIL V3, HP OV Family, HP Service Manager, Nagios, Platespin, Tivoli, TPI, SOC3, SSAE16, TOGAF
  • Sub projects/tasks
  • International project management
  • Data gathering and data consolidation of asset data
  • Preparation of the data import into enterprise service library (ESL)
  • Enterprise Architecture Modeling
  • Coaching business continuity planning and implementation
  • Contract Management TPI
  • Configuration management
  • Preparation of relationships between storage asset CIs and CIs for server, applications, business units, services, SLAs

• Time period 07/2011 - 10/2011
• Company/Branch Nürnberger Versicherungsgruppe/Insurance
• Project Implementation of EU SEPA
• Role(s)
  • Coach for program management (multi project management)
• Tools/Standards
  • MS Project, SEPA, ITIL V3, Prince2, IPMA/GPM, SAP
• Sub projects/tasks
  • Coaching project planning (international)
  • Coaching resource management
  • Preparation and mentoring ongoing status reporting
  • Coaching risk management
  • Coaching Requirements Management
  • Coaching 3rd Party (subcontractor) management

• Time period 07/2011 - 09/2011
• Company/Branch TDS Fujitsu/Astellas/IT Service provider/Pharmacy
• Project Multi Project Management according GxP and SAS70 standards
• Role(s)
  • Multi project manager
• Tools/Standards
  • MS Project, ITIL V3, Prince2, GxP, SAS70, COBIT
  • Sub projects/tasks
  • International project management
  • Resource planning & management
  • Coordination of data center moves and consolidations regarding GxP compliance
  • Status reporting to top management
  • Risk management
  • Coaching business continuity planning and implementation
  • Coaching requirements management
  • Configuration management
  • Coordination and mentoring the build of scripts (work instructions, how-to, ..) related to incidents and corresponding preventive and corrective actions (CAPA)
  • CAPA & Deviation management
  • Periodic reviews of closed incidents to find areas with improvement potential for script enhancements
  • Computer system qualification & validation
  • Coaching CAPA Management (incl. deviations, gap analysis, ..)

• Time period 10/2010 - 01/2011
• Company/Branch Fujitsu/IT Service provider
• Project Outsourcing of all IT Services of Hypo RealEstate (Pfandbriefbank) to Fujitsu
• Role(s)
  • International overall project manager (program manager)
• Tools/Standards
  • ITIL V3, COBIT, ISO 20000, ISO 27000, CA Unicenter, SDM, ARS/BMC Remedy, OSM-Q, Spider, ETL, Oracle, TPI
• Sub projects/tasks
  • Project & program management
  • Claim management
  • Contract management
  • Coordination of data center moves and consolidations
  • Management of the sub-stream incident Mgmt.
  • Preparation of scripts (work instructions, standard operating procedures) related to incidents
  • Coordination of regular meetings regarding incident and problem management improvements
  • Heading the sub-stream problem management
  • Heading the sub-stream change management
  • Heading the sub-stream configuration management
  • Heading the sub-stream order management
  • Heading the sub-stream license management
  • Heading the sub-stream capacity management
  • Heading the sub-stream availability & business continuity management
  • Heading the sub-stream billing & provisioning
  • Heading the process-modeling for the whole project program

• Time period 10/2010 - 12/2010
• Company/Branch Celesio/Pharmacy
• Project Analysis of  Storage Management
• Role(s)
  • Project manager
  • Coach
• Tools/Standards
  • ITIL V3, COBIT, ISO 20000, ISO 27000, ARS/BMC Remedy, Prince2, TPI
• Sub projects/tasks
  • Project planning and management (international)
  • Resource-Management
  • Analysis & negotiation (business & technical oriented) of contracts for storage  management
  • Requirements engineering (analysis, consulting, documentation))
  • Enterprise Architecture Modeling
  • Mentoring Business Continuity planning and implementation
  • Claim Management
  • Contract-Management in general

• Time period 08/2010 - 09/2010
• Company/Branch DekaBank Luxembourg/Bank
• Project Security initiative according to BSI Gundschutz
• Role(s)
  • Auditor
  • Consultant
• Tools/Standards
  • BSI Grundschutz, COBIT, ISO 27000, ITIL
• Sub projects/tasks
  • Consulting the design of controls and certification documents
  • Mentoring the execution of the controls
  • Mentoring the planning and preparation of measures, execution of the measures and documenting the results 

• Time period 04/2010 - 07/2010
• Company/Branch Deutsche Bank/Bank
• Project Analysis and redesign of the operations processes/workflowsfor all areas
• Role(s)
  • Project manager
  • Coach
  • Process-Designer
• Tools/Standards
  • ITIL V3, MS Project, use case modeling, AdoIT, Adonis
  • Sub projects/tasks
  • International project management
  • Analysis of existing processes, harmonization of existing processes for all kind of infrastructure
  • Coordination and mentoring of the preparation of documents (scripts) related to incident and problems based on the analysis of past requests
  • Preparation of data center moves
  • Design of a centralized order management for operations processes
  • Design of fulfillment processes for maintenance,
    troubleshooting, build, migration, disaster recovery, business continuity management, patching and operations
  • Definition of KPI for every process block
  • Definition of process interfaces and reparation of interface documents
  • Coaching the operations heads
  • 3rd Party Service Provider connection via SLAs/OLAs

• Time period 11/2009 - 03/2010
• Company/Branch Sanofi-Aventis/Pharmacy
• Project Software engineering and project management workflow redesign in compliance with GxP
• Role(s)
  • Project manager
  • Process designer
  • Coach
• Tools/Standards
  • ITIL V3, MS Project, Atlassian Jira,Serena Tool Suite, Oracle, MS SQL Server, Web CMS (php Basis), Java Script, php, Zachmann Framework, TOGAF Framework, GxP,FDA, RIF (Requirements Interchange Format), RUP Use case modeling, SCRUM, Aruba, Agile SW development methods, story boards, ETL, MySQL, MS Project
• Sub projects/tasks
  • Analysis of the workflow model
  • Design of a new workflow/lifecycle for the whole software engineering process
  • Design of the change- and configuration management part process
  • Design of the release-management part process
  • Design of the requirements-engineering part process
  • Design of the project management process
  • Design software configuration-management
  • Mentoring the new lifecycle model in all teams
  • Design and mentoring of a new test strategy
  • Preparation of SLAs and OLAs
  • Coaching all members of the specification team
  • Coaching of the team heads
  • ITIL Trainings
  • Mentoring the whole team (25 members) in ITIL
  • Preparation of templates for the functional and design specifications
    Mentoring and coaching the resource management

 
More (older) project descriptions on request.

Products (used in projects)

• Apache
• AdoIT
• ADONIS
• Alphabet Enterprise Architecture Managment
• ARIS (Prof. Scheer)
• BMC Atrium, Patrol, Remedy
• CA Unicenter (Computer Associates)
• ClearCase, ClearQuest, ClearDTS
• ETQ
• HACMP (IBM)
• HP (Peregrine) Asset Center, Service Center, Service Manager
• Iteraplan
• JAVA
• J2EE
• Linux Cluster
• LiveLink
• LotusNotes
• MQ Series
• MS Project (Mircosoft)
• Networker (Legato)
• HP OpenView OperationCenter, NetworkNodeManager, Service Manager, Asset Center
• Oracle Agile
• Oracle DBMS (Oracle)
• Rational (complete product Suite)
• RUP
• SAP document management
• SoDa
• IBM Tivoli Storage Manager
• Oracle Sun Cluster (SUN Microsystems)
• TOGAF
• Trackwise
• TSM (IBM)
• V-Modell Editor, V-Modell Assistant
• Veritas Volume Manager (Veritas), Veritas File-System (Veritas)
• XML
• Zachmann