personalprofil hs 2013 e v01€¦ · drosselstrasse 47 ch-4059 basel tel 079 320 35 42 fax 086 079...

Drosselstrasse 47 CH-4059 Basel Tel 079 320 35 42 Fax 086 079 320 35 42 [email protected]

steiner infortech Informatik Technologie

10.02.2014 Seite 1 von 13 Personalprofil_HS_2013_E_v01.docx

Harald Steiner

E-Mail: [email protected] Mobile: +41 79 320 35 42 Office: +41 79 320 35 42

EDUCATION

1981 • Aarg. Kantonsschule Aarau, Matura Typ C

1985 • Studies in mathematics at the ETH Zürich

PROFESSIONAL EDUCATION

• IT-Project Management

• Quality Management for Pharmaceutical IT

• Test Management and Software Quality Management

• Development of Database- and Web Applications

• Computer System Validation

LANGUAGE SKILLS

• German (first language)

• English (excellent skills, oral and written)

• Italian (oral and written)

• French (oral and written)




MAJOR KNOWLEDGE AREAS

Project Management

IT Project Management, Project Consulting and Coaching

Business Analysis Requirements-Management Business Process Engineering: Feasibility Studies, Analysis, Requirements Management, Automation, Selection of Systems and Suppliers, Introduction, Rollout

Definition of Educational Processes, Procurement Processes, Facility Management Processes, Document Management

Life Science Processes: Adverse Event Management, Clinical Supply Management, Quality Control, Quality Assurance

Quality Management

Testmanagement – Organize and Execute User Tests Quality Management of IT Solutions and Services, Test Management

Computer System Validation (CSV), Qualification in Pharmaceuticals

Service Management

IT Service- and Process Management: Introduction and Enforcement of Change Management, Incident and Problem Management, Configuration Management, Release Management

IT Infrastructure Management according to ITIL

Design and Development

Conception and Development of Database Applications and Distributed Applications

PROFESSIONAL EXPERIENCE

Project-Management

Management of Projects for introduction of new Systems, IT- and Business Process optimization, Migration, Computer-System-Validation

Business Process Engineering

Definition of requirements for technical solutions Creation of data models and functional models Support of the selection of IT-Systems and -Services Process-Design and Evaluation of automated solutions

Quality Management

Design and creation of test plans and test protocols, scripts Definition of Software Quality Processes Organization and Execution of Integration tests, Performance tests, User Acceptance Tests Audits of internal IT organizations and suppliers

Computer System Validation

Analysis of CSV Requirements, Planning and execution of CSV Projects Creation and executions of validation plans and protocols Creation of Standard Operating Procedures (SOP) Introduction of Management Processes according to defined SOPs Qualification of Laboratory Equipment

IT Service- and Process Management

Definition and Introduction of IT Infrastructure Processes Life Cycle Management of Applications: Introduction, Change Management, Problem Management, Configuration Management Application Training, eLearning, Virtual Training




IT Development Data Migration Development of Database applications (Oracle, MS Access) Development of Web applications

METHODS AND TOOLS USED

Business Process Engineering

Analysis and creativity techniques: Brainstorming, Mind Map, Use Cases RACI, Swimlanes, Change Management, SWOT Analysis ARIS, Business Process Management Notation (BPMN) Requirements Management with Use Cases, User Requirements Specification, Functional/Non-Functional Requirements

Quality Management Computer System Validation

Regulations by FDA/EMEA, GxP (Life Science) and SOX Method: V-Model (CSV) Guidelines: ISO 9000 / 13485, GAMP4 Risk analysis and –management Testdirector, Testmanagement (In house Development)

Project-Management

Microsoft Project Network chart technology, effort estimations with multiplicator method Project management Guideline: vdf/Jenny HERMES, SDLC

IT Service- and Process Management

ITIL Rational Clearquest, Bugzilla, JIRA, Trackwise Remedy

IT System Development

Waterfall / V-Model Oracle, Microsoft Office (Access,MSSQL), IBM Websphere Development and Tests following the V-Model

Operating Systems, Databases

OS: WindowsXP, UNIX (Solaris, HPUX, Linux, OSX), IBM Mainframe, Unisys A-Serie, VAX/VMS DB: ORACLE (Forms, SQL*Plus), MS Access/SQL Server

INDUSTRY SECTORS

Financial Industry: UBS AG Pharma: Novartis, Roche, Schering Plough, MSD/Merck, Legacy Insurance: Gebäudeversicherung BL Transport: Schweiz. Bundesbahnen, Österreichische Bundesbahnen Energy Supplier, Utilities: EWZ, atel, AEW, RWW, cities Government: Bundesverwaltung EJPD




PROJECT EXPERIENCE: Overview

Service Project/Subject Branch/Client Year Project Management Shop-Floor-Network and SCADA Intro/Upg. Pharma, Merck 2013 Project manager (I.a. ZEMIS, DOPO) Government, EJPD 2010-12 Insourcing project ITI goes Shared Service Finance, UBS 2009 Replace learning management system Finance, UBS 2007-08 Qualification IT infrastructure Pharma, Schering-Plough 2006 Implementation web-app „Compliance“ Finance, UBS 2001 Data migration Insurance, BL Gebäudevers. 1998 Global drug safety system Pharma, Novartis 1998 Validation LIMS Pharma, Roche 1998 Energy network documentation system Government, several 1994-95 Infrastructure doc.system Railways Transport, SBB/ÖBB 1993 Develop energy network-doc.system several 1991-93 Quality Management, Tests, CSV Test manager compliance system Finance, UBS 2012-2013 Create/maintain CSV documentation Pharma, Merck/MSD 2006-13 GAP analysis GMP documentation Pharma, Gemü 2010 Validation laboratory equipment/process Pharma, Novartis 2008/09 Audit IT supplier/data center Pharma, Eclinso 2008-10 Qualification of IT Infrastructure Pharma, Werthestein/MSD 2006 Validation clin. supply chain software Pharma, Werthestein/MSD 2006 Test- and releasemanager learning platform Finance, UBS 2004-05 Clinical safety software implementation Pharma, ASP Pharma 2004 Test manager procurement platform Finance, UBS 2002-03 Reports/statistics for FDA authorization Pharma, Novartis 1998 Clinical safety DB maintenance Pharma, Novartis 1997-98 Business Consulting, Business Process Engineering Product configuration clinical safety DB Pharma, Novartis 2011-12 SLA, DR, BCP contracts and procedures Pharma, Essex/MSD 2009-10 User requirements ERP Pharma, Legacy 2008 Replace learning management system Finance, UBS 2007-08 Outsourcing learning services Finance, UBS 2006 Evaluation global learning platform Finance, UBS 2005 Clinical safety software implementation Pharma, ASP Pharma 2004 Implementation procurement platform Finance, UBS 2002-03 Implementation web-app „Compliance“ Finance, UBS 2001 Consulting business technology center Finance, UBS 2000-04 Change-/release management IT US Finance, UBS 1999 Support clinical development Pharma, Novartis 1998 Data migration Versicherung, BL Gebäudevers. 1998 Develop/maintain adverse event DB Pharma, Novartis 1997-98 Global drug safety system Pharma, Novartis 1998 IT Consulting, IT Service- und Process Management Enhancement drug safety system Pharma, Novartis 1996 Energy network documentation system Energie, Genf 1994-05 User requirements infrastructure DB Transport, SBB/ÖBB 1993 Energy network documentation system Energie, CAD RZ 1991-93 Software Development Develop „Catalogue Management“ DB Finance, UBS 2006 Develop ORACLE, SQL Pharma, Novartis, MSD 1996-2011 Develop in Pascal, Fortran, Cobol, C, Basic ABB, UNISYS, UBS, Fides, … 1981-1994




PROJECTS AND EXPERIENCE: Project Management

Subject Shop-Floor-Network Setup and Qualification Year / Duration

2013

My role Project Manager Project Description / Responsibility Service Build a shop floor network to support manufacturing of new drug substance. Deploy and qualify network, support FDA inspection readiness activities

Project Manager

Subject Project Manager ZEMIS Year / Duration

2010/ 2012

My role Project Manager Project Description / Responsibility Service ZEMIS is one of the main systems of the Swiss federal justice department. It is co-developed by internal IT and external supplier and run internally. As a project manager I was responsible for the planning and coordination of internal development and operations teams and the management of the releases and sub-projects like ZEMIS BÜG for the internal IT and external supplier.

Project Manager

Subject Insourcing Project ITI goes Shared Service Year / Duration

Q3 2009

My role Project Manager Project Description / Responsibility Service Insourcing of external service for training event management. business process definition, organization and technical environment definition, migration to existing learning platform

Project Manager

Subject Replace Learning Management System My role Project Manager

Year / Duration

2007/ 2008

Project Description / Responsibility Service Project StepUP: Reconstruction and upgrade of a Learning Management Systems of a financial service provider. Management of project stream „Business Processes and Organization“. Definition and implementation of business processes

Project Management Business Process Eng.

Subject GxP Qualification IT Infrastructure My role Project Manager , CSV Specialist

Year / Duration

2006

Project Description / Responsibility Service Qualification of IT Infrastructure of a Data Centers within international Pharma-Division. Create validation plan, risk analysis, execution of qualification protocols for servers, Network and Data Center. Standardizations of Desktop Clients Environment. Create and train SOPs

Project Management CSV




PROJECTS AND EXPERIENCE: Project Management

Subject Web-Application „Compliance Test“ My role Project Manager, IT System Analyst

Year / Duration

2001

Project Description / Responsibility Service Project Management Project „Compliance Test“: Introduction of a Web-based solution for employees. Computer based assessment for employees in compliance of financial institution

Project Management Analysis, Concept

Subject Data Migration My role Project Manager, IT System Analyst

Year / Duration

1998

Project Description / Responsibility Service Data Migration of old, host-based insurance application into a new system. Project management, functional specifications, approval of data migration

Project Manager IT Analysis and concept

Subject Global Drug Safety System My role Project Manager, Business Analyst

Year / Duration

1998

Project Description / Responsibility Service Project GDSS (Novartis): Introduction of global Drug Safety Systems. Team leader „Data migration SAERS – GDSS“. Specification Data Migration


Subject Energy Network Documentation System My role Project Manager, IT System Analyst

Year / Duration

1994-1995

Project Description / Responsibility Service Development of Systems "LIDS" for project "SIG", "Services Industrielles de Genève". Definition of requirements and development. Sales support for local sales organization at Lausanne: Project Manager, Requirements Specification


Subject User Requirements and Design of Infrastructure Documentation System for Railway Company

My role Business Analyst, Project Manager

Year / Duration

1993

Project Description / Responsibility Service Austrian Railways, Vienna: project "BVWA": Definition of requirements and vendor selection for "Bestandsverwaltung der Anlagen". Project management for the modules for buildings, bridges and underplanting and interfaces to accounting: Requirements management, creation of functional- and data model

Business Process Management Project Manager

Subject Development of Energy Network Documentation System

My role Project Manager, IT System Analyst

Year / Duration

1991-1993

Project Description / Responsibility Service CAD Rechenzentrum, Basel: Software Development and Project Management. CAD RZ develops and distributes a in house geographical information system (GIS). Project management for introduction of the systems for clients, leader of the support teams, requirements definition for customization and customer specific development

Project Manager IT Analysis and Concept




PROJECT EXPERIENCE: Quality and Test-Management, Computer System Validation

Subject MK-3475 manufacturing Year / Duration

2013

My role CSV Specialist Project Description / Responsibility Service Support CSV activities for MK-3475 manufacturing, preparation of FDA inspection of manufacturing plant

CSV

Subject Test Manager for Compliance and Recertification-Module

My role Test Manager

Year / Duration

2013

Project Description / Responsibility Service Global testmanager for upgrade and extension of a worldwide learning management system with functions for automated audience building, invitation, monitoring (reminding, chasing). Coordination and organization of test resources and testers in UK, Asia, USA, Australia and Switzerland

Subject Maintenance/ Improvement of CSV Documentation

My role CSV Specialist

Year / Duration

2006 – 2012

Project Description / Responsibility Service Maintenance and completion of Computer System Validations-Documentation for a data center of a pharmaceutical company. Consulting for validation of GxP Infrastructure for SAP environment. Create SOPs for Change Management, Training Records Management, Problem Management, Patch Management, Configuration Management. Creation of Business-Continuity- and Disaster- Recovery-Plan. Enforce and Monitor SOPs

CSV

Subject GAP Analyse for CSV Medical Device Manufacturer

Year / Duration

2010

My role CSV Specialist Project Description / Responsibility Service GAP Analysis according to GAMP 5 for the validation of the computer systems and applications of a medical device manufacturer

CSV Consulting

Subject Qualification/Validation of Laboratory and Production Equipment

My role Consultant

Year / Duration

2008/ 2010

Project Description / Responsibility Service Preparation of FDA Inspection: assessment and cleanup of qualification documents and procedures. Planning and qualification of laboratory- and production equipment

Validation and Qualification

Subject Audit My role Auditor

Year / Duration

2008/ 2010

Project Description / Responsibility Service Audit of third party service supplier for a software and service provider to the pharmaceutical industry to support the clinical development

Auditing





Subject Collect User Requirements for ERP My role Business Analyst, CSV Specialist

Year / Duration

2008

Project Description / Responsibility Service Creation of the user requirements document for the selection of a new ERP of a manufacturer of pharmaceutical products. Definition of the requirements for production planning, procurement, quality assurance and control, maintenance and general system requirements

Validation Business Process Eng.

Subject GxP Qualification IT Infrastructure My role Project Manager , CSV Specialist

Year / Duration

2006

Project Description / Responsibility Service Qualification of IT Infrastructure of a Data Centers within international Pharma-Division. Create validation plan, risk analysis, execution of qualification protocols for servers, Network and Data Center. Standardizations of Desktop Clients Environment. Create and train SOPs

CSV

Subject Validation Application Software CSTS My role CSV Specialist

Year / Duration

2006

Project Description / Responsibility Service „CSTS“ Introduction of application for Clinical Supplies Tracking and „Clinpro“: Definition of validation activities, create test protocol, execution of tests, create validation summary

CSV

Subject Enhance Learning Platform My role Business Analyst, Testmanager, Releasemanager

Year / Duration

2004-2005

Project Description / Responsibility Service Design and introduction of new modules for mass enrollments, catalog management, assessments Quality Assurance/Test Manager for the learning platform STEP with a course management and a content management system Release Management

Business Process Management

Subject Support Clinical Safety Application Service Provider My role Business Consultant

Year / Duration

2004

Project Description / Responsibility Service Consulting and support of marketing and sales activities for software systems AERS Feasibility studies for Tracking System Creation of sales documentation


Subject Introduction of Procurement Platform My role Testmanager, Change Management

Year / Duration

2002-2003

Project Description / Responsibility Service Quality Assurance/Test Manager for the introduction of the procurement platform MyShop/SAP


Subject Support Clinical Development My role CSV Specialist, IT Specialist

Year / Duration

1998

Project Description / Responsibility Service





Development of reports and statistics for the approval for new pharmaceuticals Creation of validation documentation for „Global Drug Safety System“ ARGUS: Test protocols for data migration

CSV

Subject Enhancement and Maintenance of Adverse Event DB

My role Business Analyst, IT System Analyst, CSV Specialist

Year / Duration

1997-1998


Global System Administrator for the system SAERS at Novartis Clinical Safety: Database with side effects for pharmaceuticals. • Requirements Management, Specification of enhancements • Change Management • Release Management • Computer System Validation

Business Process Management CSV




PROJECT-EXPERIENCE: Business Analysis, IT Service and Process Management, Development

Subject Clinical Safety Expert Year / Duration

2011/ 2012

My role Business Consultant Project Description / Responsibility Service Configuration of application database with information of clinical safety, products, organization and regulatory documentation

Business Process Eng., Configuration

Subject Data Center Operations Year / Duration

2009 – 2010

My role IT Consultant Project Description / Responsibility Service Definition of service level agreements, disaster recovery concept and plans, definition of procedures for maintenance, problem management, change management and monitoring

Service Management, Disaster Recovery

Subject Collect User Requirements for ERP My role Business Analyst, CSV Specialist

Year / Duration

2008

Project Description / Responsibility Service Creation of the user requirements document for the selection of a new ERP of a manufacturer of pharmaceutical products. Definition of the requirements for production planning, procurement, quality assurance and control, maintenance and general system requirements

Validation Business Process Eng.

Subject Replace Learning Management System My role Business Analyst, Project Manager

Year / Duration

2007/ 2008

Project Description / Responsibility Service Project StepUP: Reconstruction and upgrade of a Learning Management Systems of a financial service provider. Management of project stream „Business Processes and Organization“. Definition and implementation of business processes

Project Management Business Process Eng.

Subject Outsourcing Learning Services My role Business Analyst

Year / Duration

2006

Project Description / Responsibility Service Project IRCL: Building a worldwide service-center and the technical Infrastructure for training of employees of financial institution: proposal for implementation of requirements, business process design, organization, change management

Business Process Eng.

Subject Development „Catalog Management“ My role Software Engineer

Year / Duration

2006

Project Description / Responsibility Service Project KatalogDatabase: Design and Realization of a system to automate the creation of training catalogs

System Development





Subject Selection of global learning platform My role Business Analyst

Year / Duration

2005

Project Description / Responsibility Service Selection of unique, global learning platform: Requirements Management, Evaluation and assessment of proposals and solutions for a global training system. Create RFP and SWOT Analysis for offered solutions


Subject Enhance Learning Platform My role Business Analyst, Testmanager, Releasemanager

Year / Duration

2004-2005

Project Description / Responsibility Service Design and introduction of new modules for mass enrollments, catalog management, assessments Quality Assurance/Test Manager for the learning platform STEP with a course management and a content management system Release Management


Subject Support Clinical Safety Application Service Provider My role Business Consultant

Year / Duration

2004

Project Description / Responsibility Service Consulting and support of marketing and sales activities for software systems AERS Feasibility studies for Tracking System Creation of sales documentation


Subject Introduction of Procurement Platform My role Testmanager, Change Management

Year / Duration

2002-2003

Project Description / Responsibility Service Quality Assurance/Test Manager for the introduction of the procurement platform MyShop/SAP


Subject Web-Application „Compliance Test“ My role Project Manager, IT System Analyst

Year / Duration

2001

Project Description / Responsibility Service Project Management Project „Compliance Test“: Introduction of a Web-based solution for employees. Computer based assessment for employees in compliance of financial institution

Project Management Analysis, Concept

Subject Consulting Business Technology Center My role IT System Analyst Business Analyst

Year / Duration

2000-2004

Project Description / Responsibility Service Introduction of a unique Change Managements, Problem-Management and Release-Management for all applications of a division of financial institution Representing the division’s requirements in infrastructure and standardization projects Representation of user requirements versus IT service provider Consulting for project UFIM (Facility Management project)

Business Process Management IT Consulting





Subject Change- and Release Management for IT User Support unit

My role IT System Analyst

Year / Duration

1999

Project Description / Responsibility Service Coordination of introduction and rollout of client desktop applications and standardization of application portfolio. Coordination and management of introduction and distribution for all applications of one division of financial institution. Maintain application portfolio. Release Management.


Subject Support Clinical Development My role CSV Specialist, IT Specialist

Year / Duration

1998

Project Description / Responsibility Service Development of reports and statistics for the approval for new pharmaceuticals Creation of validation documentation for „Global Drug Safety System“ ARGUS: Test protocols for data migration

CSV

Subject Data Migration My role Project Manager, IT System Analyst

Year / Duration

1998

Project Description / Responsibility Service Data Migration of old, host-based insurance application into a new system. Project management, functional specifications, approval of data migration


Subject Enhancement and Maintenance of Adverse Event DB

My role Business Analyst, IT System Analyst, CSV Specialist

Year / Duration

1997-1998


Global System Administrator for the system SAERS at Novartis Clinical Safety: Database with side effects for pharmaceuticals. • Requirements Management, Specification of enhancements • Change Management • Release Management • Computer System Validation

Business Process Management CSV

Subject Global Drug Safety System My role Project Manager, Business Analyst

Year / Duration

1998

Project Description / Responsibility Service Project GDSS (Novartis): Introduction of global Drug Safety Systems. Team leader „Data migration SAERS – GDSS“. Specification Data Migration






Subject Development Drug Safety System My role IT System Analyst

Year / Duration

1996

Project Description / Responsibility Service Development of Drug Safety Monitoring System SAERS and OSCAR: team leader development, functional specification of enhancements

Team Leader IT Analyse und Konzept

Subject Energy Network Documentation System My role Project Manager, IT System Analyst

Year / Duration

1994-1995

Project Description / Responsibility Service Development of Systems "LIDS" for project "SIG", "Services Industrielles de Genève". Definition of requirements and development. Sales support for local sales organization at Lausanne: Project Manager, Requirements Specification


Subject User Requirements and Design of Infrastructure Documentation System for Railway Company

My role Business Analyst, Project Manager

Year / Duration

1993

Project Description / Responsibility Service Austrian Railways, Vienna: project "BVWA": Definition of requirements and vendor selection for "Bestandsverwaltung der Anlagen". Project management for the modules for buildings, bridges and underplanting and interfaces to accounting: Requirements management, creation of functional- and data model

Business Process Management Project Manager

Subject Development of Energy Network Documentation System

My role Project Manager, IT System Analyst

Year / Duration

1991-1993

Project Description / Responsibility Service CAD Rechenzentrum, Basel: Software Development and Project Management. CAD RZ develops and distributes a in house geographical information system (GIS). Project management for introduction of the systems for clients, leader of the support teams, requirements definition for customization and customer specific development

Project Manager IT Analysis and Concept

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