Consulting Profile Gymnasium Wr. Neustadt, Austria. Food- and Biotechnology

Transcription

1 Consulting Profile Name: Dipl. Ing. Herbert Schwarz Address: Rudolf Pöchgasse 12/10, A Vienna Tel.: Family: Birth: Nationality: Married, 1 child in Neunkirchen (NÖ) Austria EDUCATION School: Primary School Krumbach, Austria Gymnasium Wr. Neustadt, Austria Study: Univ. of Agriculture, Vienna, Austria Food- and Biotechnology Certificates: Quality Manager DGQ/EOQ Project Manager PRINCE2 Foundation SKILL SET / EXPERIENCE Applications: LIMS /ELN - Labor Information- Management Systems Electronic Laboratory Notebook Labware LIMS, SQL*LIMS, QDIS/QM, SAP/QM, Collier, Maqsima LIMS, Labora, Lab SP, Lab X IT Quality Systems: Environmental Monitoring ELPROLOG CAQ=QSYS, SPC MES - Manufacturing Execution Systems Interfaces to ERP Systems SAP MM, PP, PP-PI Data Warehouses (SAP-BI, Oracle) Page 1 of 13 Version date: 16 Dec-2014

2 Consulting Profile Basis technologies: Data bases: Oracle, SQL, PL/SQL, SQL*Developer Report generators: Oracle Reports, Centura Report Builder, Crystal Reports Programming languages: Oracle Forms, LIMS Basic, Team object manager Operating systems: Windows, Sun Solaris, and Citrix MS Office 2013 Professional (Word, Excel, Power point, Access, Outlook, etc.), MS Project, SharePoint, Jira Management skills: Project management Quality management (ISO9000, GxP) Process management Software Life Cycle Management Validation, GAMP, 21 CFR part 11 Branches: Pharmaceutical - / Life Science Industry, Process Industry (Food- Chemistry) Soft skills: Business English Leadership skills Team building and developing Alignment with the stakeholders Project communication, active listening Business and technical writing skills Social competence Page 2 of 13 Version date: 16 Dec-2014

3 Consulting Profile 03/ /2015 Pfizer, Austria - (LIMS Project Management Roll Out -Global LIMS for Quality Control Roles and responsibilities: - Site Project Manager Technology and Methods: - Project Planning and follow up progress against plan - Build up and managing local project team - Master Data Management - Issue and Risk Management - Validation Lead - Training Lead - Train the local SMEs - Alignment with SAP Rollout project - Alignment with Global LIMS team in USA - Stake Holder relationship management MS Project, Labware LIMS Version 6, Oracle 11, Citrix Pfizer glims project methodology Windows 2003, XP, ALM (hpqc) Crystal Reports, LIMS Basic 02/ /2015 Hilron /Trumpf Medical Business Analysis - SAP/QM Process Mapping Roles and responsibilities: - Analysis legacy SAP System - Process Mapping Quality Processes against new version of SAP/QM - Business Blue print creation - Status reporting Technology and Methods: Deloitte Process Mapping Tool, Pool4Tool SAP/QM Page 3 of 13 Version date: 16 Dec-2014

4 05/ /2014 Johnson & Johnson - DePuy Syntes AG Project Management Validation IT Quality and MES Systems Roles and responsibilities: - IT Project Management - Project Planning (Time, Resources Costs, Quality) - Leading and coordination of 4 multi discipline project teams (Deloitte Program Management, Resources Customer) - Issue and Risk Management - Manage the vendor / agree and follow up on deliverables - Coordinate with Infrastructure team - Change Control and Release Management - Stake Holder Relationship Management - Progress reporting/ align with PMO /Project Controlling - Implementation and prospective Validation Environmental Monitoring System ELPROLOG - Retrospective Validation MES FDMFORCAM - Retrospective Validation Service Management DB - Retirement Audit Management System Technology and Methods: FDMFORCAM, ELPROLOG, SQL*Server, MYSQL PHP, TCP/IP, Clean Room Monitoring SDLC, JnJ GRQP Computer Validation Policy Windows 2012, Windows 7 / IE 7 MS Project 09/2013 today Fresenius-Kabi AG Validation global Complaint- Management System Roles and responsibilities: - Validation- Coordination - Time and Resource Planning and Management - Coordination international Project team (External Consulting house with Programmers and Tester, global Organization of final customer) - Issue Management - Risk Management - Change Control and Release management - Stake Holder relationship management

5 - Status Reporting Technology and Methods: Individual Software based on SharePoint, SQL*Server, Fresenius Kabi Computer Validation Methodology Windows 2012, Windows 7 / IE 7 SAOP Solution Manager 10/2013 today Budenheim Chemische Fabrik LabWare LIMS Implementation of Enhancements Roles and responsibilities: - Project management - Data transformation of instrument raw data (Parsing Scripts) Modelling of data for Data integration Instrument Interfacing > LIMS > SAP/QM - Resource Planning and Management Technology and Methods: LabWare Lims V6, Labsstation, SQL*Server 2012 LIMSCON Project Methodology Windows 2012/ 7 /8.1 Chromaeleon, Special Analysis (Horiba, BET, etc.) SAP/QM Master Inspection Lot Plans 01/ /2013 Johnson & Johnson AG, Diagnostics Beerse (Belgium) Labware LIMS Implementation in R&D) Roles and responsibilities - Technical Project manager /Project Coordinator IT - Project Planning (Time, Resources Costs, Quality) - Team lead and Coordinator international Project team (Consultants, Programmer and Tester from 5 States USA, 4 countries EU) - Head Test Team and Validation Coordination - Coordinate with Infrastructure team - Task Management - Issue and Risk Management - Change Management and Release management - Stake Holder relationship management /Business alignment - Status and Progress Reporting - Manage the vendor - Agree with vendor on deliverables (Statement of Works)

6 Technology and Methods: Labware Lims Version 6, Oracle 11, Citrix Johnson & Johnson Project Methodology Windows 2009, XP/Windows 7 Crystal Reports, LIMS Basic hp Quality Center, Share point, MS Project, Doc Space 08/ /2013 Omega Pharma Manufacturing GmbH, Germany Migration LIMS > SAP/QM Roles and responsibilities: - Project management - Data Extraction and Transformation Master Data LIMS > SAP/QM - Data Evaluation and Trend reporting historical Data with SAP Crystal Reports - Preparation of the Data for Archiving in Data Warehouse - Data extraction /archiving historical Dynamic data - System Life Cycle Documentation and Validation - Risk Management - System Management - Change Control and Release management Technology and Methods: Beckmann LIMS, Oracle 7, Open VMS LIMSCON Project methodology Windows 2003, XP ERP Systems AS/400 (JDE, BPCS) Cloning and Images creation of Process PCs SAP/QM Master Inspection Lot Plans 04/ /2012 Glaxo Smith Kline GmbH, Germany- Project Management Implementation MES Balance system in Bulk Manufacturing Roles and responsibilities: - Project management - System architect - Programming LIMS > WINCIS Interface - System integration - System Life Cycle Documentation and Validation - Risk Management

7 - System Management - Change Control and Release management Technology and Methods Beckmann LIMS, Oracle 7, Open VMX GSK project methodology Windows 2003, XP Cloning and Imaging Process PCs WINCIS (Bizerba) 10/ /2012 Glaxo Smith Kline GmbH, Germany (Archiving and Migration ERP / LIMS/ Chromatography system, Project Management, VMWare Implementation) Roles and responsibilities: - Work stream lead Virtualization and Arching Chromatography systems - Local Coordinator - Team member ERP Systems JDE, BPCS - System migration planning and Documentation - System Life Cycle Documentation and Validation - Risk Management - System Management - Change Control and Release management - Stake Holder relationship management Technology and Methods: Beckmann LIMS, Oracle 7, Open VMX GSK project methodology Windows 2003, XP ERP Systems AS/400 (JDE, BPCS) WINCIS (Bizerba) 02/ /2011 Roche AG, Basel (LIMS Project Management Sample logistic LIMS Clinical) Roles and responsibilities: - Senior Project Manager IT - Agree with vendor on deliverables (Statement of Works) - Manage the internal development and test team - Manage the budget and the follow up on costs

8 - Work closely with the Business PM to align on goals - Issue and Risk management - Coordinate with Infrastructure team - Change Management - System management - Change Control and Release management - Stake Holder relationship management Technology and Methods: Labware LIMS Version 6, Oracle 11, Citrix Roche project methodology Windows 2003, XP Crystal Reports, LIMS Basic 09/ /2010 Merz Pharmaceuticals, Frankfurt (LIMS System analysis and System selection for R&D) Roles and responsibilities: - User requirements definition - Supplier selection - Moderation of Supplier workshops - Project calculation and planning - Business case creation Methods: Own developed method 07/ /2010 Roche AG, Basel (LIMS Change Management for Labware LIMS) Roles and responsibilities: - Implementation Labware LIMS for Biological Analytics (DNA, RNA Analysis) - Adaption of Reports (Centura/Gupta Reports) - Design and programming of enhancements with LIMS Basic - Automatization of sample logging Technology and methods: Labware Lims Version 6, SQL*Server 2005, Citrix XEN App Server and Citrix Web Clients, Windows 2003, XP Crystal Reports, LIMS Basic)

9 04/ /2010 Philip Morris Research GmbH, Köln (LabwareLIMS for R&D) Roles and responsibilities: - Implementation Labware LIMS for Affymetics (RNA Analysis) Adaption of Reports (Centura/Gupta Reports) - Design and programming of Enhancements with LIMS Basic Technology and methods: Windows 2003, XP Basic) LabwareLIMS Version 6, SQL*Server 2005, Citrix XEN App Server and Citrix Web Clients, Crystal Reports, LIMS 07/ /2010 Bayer Business Services GmbH, Berlin (LIMS Support for Bayer Healthcare AG) Roles and responsibilities: - Support QDIS/QM (Waters AG) - Implementation Change Control System - Adaption of Reports (Centura/Gupta Reports) - Incident Management - Release change- and Infrastructure change (Citrix environment) - Licence management Technology and methods: QDIS/QM, Oracle 10g, Citrix XEN App Server and Citrix Web Clients, Windows 2003, XP Centura Reports, Team Object Manager (Unify) 09/ /2010 Orinada AG (LIMS Data Warehouse for archiving of legacy data for Swiss Pharmaceutical company ) Roles and responsibilities - Concept, Consulting and Analysis of Requirements - Coordination of Development Resources. - Review of Data extracts from QDIS/QM (Waters AG) - Review of Source Codes for Data extracts to SAP-BI

10 - Conducting Tests Technology and methods: QDIS/QM, SAP-BI, SQL*Developer, Oracle 09/ /2009 Implementation of R&D LIMS (Laboratory Information System ) at Gruenenthal AG, Aachen (Central Analytics) Roles and responsibilities: - Process Analysis and Configuration Labware LIMS - Instrument management - Deviations and Exception Management - Life Cycle Documents ( Functional Specs, Design Specs) - Design and programming of Enhancements with LIMS Basic Technology and methods: Labware LIMS, Oracle 10g, Citrix, Windows 32bit GAMP IV, 21 CFR part11, MS Project, SQL Developer, LIMS Basic

11 09/ /2008 Implementation of R&D LIMS (Laboratory Information System ) at Merck Serono k.g a.a, Munich (DMPK Institute) Roles and responsibilities: - Project coordinator LIMS in Clinical & Preclinical DMPK/ADME institute - Implementation SQL*LIMS - Process analysis and process reengineering - Configuration management - System validation co-coordinator - Life Cycle Documents (User Requirements, Functional Specs, Design Specs, Risk analysis, Testing plans, etc.) - Design and programming of interfaces to MS/ HPLC, Eliza - Programming of Oracle - PL/SQL Scripts enhancements of SQL*LIMS database Technology and methods: SQL*LIMS, Limslink, Oracle 8i, Citrix, Windows 32bit GAMP IV, 21 CFR part11, MS Project, SQL Developer, Java Developer 03/ /2005 Boehringer Ingelheim Austria, Vienna (Pharma / Biopharmaceutical) Roles and responsibilities: - Project manager LIMS - Implementation LIMS (QDIS/QM Waters) - Process analysis and process reengineering - Configuration management - Head of LIMS group - Responsible for validation - Life Cycle Documents (User Requirements, Functional Specs, Design Specs, Risk analysis, testing plans, etc.) - Design of interfaces to ERP (System 21, SAP/QM) and MES Technology and methods: QDIS/QM, Oracle 9i, Citrix, Windows NT, GAMP IV, 21 CFR part11, MS project

12 08/ /2002 Baxter AG, Vienna (Pharma/ Biopharmaceuticals) Roles and responsibilities: - Manager Quality Systems. - Implementation SQL*LIMS - Head of LIMS group - Support of legacy Quality Systems - Global system selection of QM software - System configuration management Technology and methods: SQL*LIMS, Oracle 8i, Citrix, Sun Solaris, Windows NT 01/99-09/99 Coca-Cola Central Europe Division, Vienna, Austria / Beverages) Roles and responsibilities: - Quality Improvement Engineer. - Supplier Audits - Planning Electronic Quality Document Management System - Supporting CCB on Quality Improvement Process Technology and methods: The Coca Cola Quality System, Lotus Notes 11/ /2000 Project engineer procurement Akras Flavours AG Roles and responsibilities: - Project engineer procurement - Selection of an ERP System - Global procurement projects 07/96-12/98 Consultant at Mettler / OrgaTreu Consulting Roles and responsibilities - Consulting of LIMS / CAQ /CAM. - Project management - Design of software modules

13 - Training of clients - Customizing of software Technology and methods: LIMS / CAM: Oracle 7, Delphi, SAP R/3 (Module MM, QM, PP, PP/PI) 10/ /1996 Quality manager at WIBERG (Food industry Roles and responsibilities - Head of Quality Assurance - Implementation of LIMS - Head of laboratory (GC, HPLC, chemistry, microbiology - Corrective and preventive actions. - Certification acc. ISO Audits and assessments Technology and methods: AS/400, QS module LIMS (Labora),MS Access