1. MARTIN JONAS
Switzerland: United Kingdom: Tel & E-mail:
Hauptstrasse 2
4322 Mumpf
Switzerland
19 The Croft
Ulgham, UK
NE61 3BB
Mobile +41 79 957 50 97
Email: mwjonas@aol.com
Synopsis: Hands-on PHARMA Quality Management skills and experience -14 years
− Global GxP Cloud Infrastructure Virtualisation Programme roll-out (50 sub-projects over 3 years
incorporating vBlock, Nutanix, Network-attached Storage, Backup, Physical to Virtual Application
Transformation and Migration)
− Cloud Service Operations Quality Management (incorporating Service Setup, device- and system
qualification)
− SAP ARMM (150 SAP systems; infrastructure transformed and migrated over 2 years)
− SAP ERP Applications setup- and upgrade validation
− LIMS (Lab-vantage) validation
− HVAC Validation
− Automated packaging printing validation
− Stabilization Chamber validation
− Engineering Maintenance system validation
− Setup and validation of UPS and generator back-up power supply
− Business Continuity Planning and maintenance across all aspects of a PHARMA manufacturing
site
− Establishment of site HSE Governance
− Finance 12 years: Management-, Project- and Financial Accounting (in the role of Finance Manager)
− Languages: Excellent English, Afrikaans; understand and speak basic German and Dutch
Experience:
Back-to-back consulting engagement as Senior Quality Manager at Novartis, Basel
October 2010 to present:
Programme Quality Manager, Infrastructure Transformation on Global GxP Cloud
− Designed and implemented Global Industrialised qualification of GxP vBlock deployment on GxP
Cloud
− Design and implementation Global Industrialised Application Migration from physical to virtual
infrastructure on Windows and Linux
− Design and implementation of Global Industrialised LOC consolidation and migration
Global Operations Quality Manager, Virtual Hosting Service (GxP CLOUD)
January 2013 to July 2014
− Setup, Maturation, Maintenance of GxP Cloud for GxP, SOX, Information Security, Data Privacy
− Maturation of REMEDY Change Management
− Maturation of REMEDY Configuration Management
− Automation of Virtual Server
− Leveraging of supplier deliverables for qualification
Project Quality Manager, Setup and launch of Virtual Hosting Service on VCE vBlock, Basel
October2012 to December 2012
− Qualification of vBlock
− Qualification of Virtual Servers
− Pilot Migration of Applications to vBlock
− Setup of governance for Virtual Hosting Service
Programme Quality Manager on months SAP ARMM Upgrade Programme at Novartis, Basel
October 2010 to September 2012:
− Programme Quality Manager on SAP ARMM (Accelerated Risk Mitigation and Migration)
− Migration of 46 SAP global landscapes, 235 tollgates (project check points in ICE)
− Industrialised process
− Developed Change Control for Integration Management of Engineering, Basis design and build,
Industrialised Implementation, Cutover
− Data Centre readiness (structural facility)

2. − Infrastructure readiness
Project at GSK Montrose - Validation of the implementation of SAP R/3 v 4.7 (MERPS2) for API
− Delivered an excellent validation package on time
− Took initiative to create personal awareness with regard to each project team member’s responsibility,
especially regarding the adherence to task delivery dates.
− Rationalised CSV practice by adopting existing procedures rather than creating new project
procedures in parallel (Change Control, Incident Management, Document Management)
− In reviewing documentation I made a considerable contribution towards correct language, logic and
referencing practice
Extended contract at GSK Montrose:
− QMS GAP analysis for validation in facilities
− GAP analysis on CSV and recommendations for enhancement of CSV procedures
Previous: SANDOZ, South Africa:
− Developed Validation Protocols/Plans, , managed CSV for all the following projects:
− SAP R3 ERP validation – approximately 30 staff involved on site as well as in Kundl, Austria
− Building Management Control Systems & HVAC validation
− Stability Chambers Climatic Control validation
− BPCS validation (prior to SAP)
− Migration from BPCS to SAP
− LabVantage LIMS validation
− Bespoke Interface LIMS and ERP systems
− Bespoke Production Tracking Label system
− Bespoke Electricity Distribution system
− Bespoke Packaging Design System to serve Uhlman Blisterpack lines
− MP3 Engineering Maintenance Management system
− Network Infrastructure for 500 users
− Represented Novartis South Africa for CSV in audits from MHRA, Denmark, The Sudan, Brazil, South
Africa, and the World Health Organisation
− Developed SOP structure for Health, Safety & Environment and Developed, Implemented and
Managed Business Continuity Programme across all aspects and disciplines of the business
Work History
Oct 2010 to present: Consulting Multinational, Switzerland
Permanent position: Senior Lead Consultant in CSV
Jan 2008 to Oct 2010: Sabbatical to write on Change Control
Took time off to develop an innovative approach in book form on change control in the pharmaceutical
industry.
Filling in time between contracts as multi-skilled self employed builder
Oct 2006 – December 2007 GlaxoSmithKline Plc, Montrose, Scotland, UK
(A multinational manufacturer of pharmaceutical product – API Plant)
Computer Validation Specialist and Co-ordinator on SAP (MERPS) Installation Project
− Reporting to the Operations Quality Manager and Global Validation Manager, responsibilities included
overseeing Computer Validation Process
− Creation of Governance documentation
− Creation and direction of Infrastructure documentation
− Reviewing of all CSV documentation for the project
− Overseeing: Data Migration, Configuration Management, Testing
− Ensuring compliance with CFR Part 11, GAMP, EU Annex 11 standards, authoring of final Validation
Report.
1999 – 2005 Novartis South Africa (Pty) Ltd
(A multinational manufacturer of pharmaceutical products.)
2004 – 2005 IT Quality Manager, Novartis South Africa (Pty) Ltd, Spartan, Johannesburg, South
Africa
− Reporting to the Director: Finance, IT and Logistics - responsibilities included overseeing
infrastructure qualification, information security, and business continuity programme, maintenance to
CFR Part 11, GAMP, EU Annex 11 standards.
− Restructured and implemented Occupational Heath and Safety Act policies and procedures.

3. Major Achievements:
− Delivered a better IT interface for the other international segments of the company and helped meet
international GMP (Good Manufacturing Practice) regulatory requirements for pharmaceutical
manufacturing by redesigning and qualifying infrastructure
− Validation of SAP ERP implementation
− Comprehensive validation of HVAC and Building Management System.
− Developed a training management programme to align training with job requirements including
curriculum, controls, and measurement.
− Provided the process to meet HSE regulatory and legal requirements by developing an SOP structure
for site security and also for Health, Safety and Environment.
1999 – 2003 Contract Technical Writer and Coordinator for Computer System Validation /
Business Continuity Programme Coordinator, Novartis South Africa (Pty) Ltd, Spartan,
Johannesburg, South Africa
Personal Qualities and Achievements:
Leadership
− Have managed large teams successfully.
− Aware of the need for clear communication
− Able to convince, train, and drive clients toward on-time performance in terms of time, volume, and
quality by establishment and agreement of a base for project planning and measurement.
Accounting
− Managed accounts and administration
− International management reporting.
− Group Accounts Consolidation
Business Analysis
− Conversion of manual systems to computerised- and automated systems of accounts, designing
shipping control procedures, stock control systems, job costing systems, and security control with
overall accounting systems.
Communication
− Able to present a situation clearly with concise and effective technical writing that would encompass
client requirements, system specifications, testing specifications, and validation reports.
− Able to help others to solve problems to the benefit of the individual and the company as a whole.
− Can liaise confidently with top executives as well as all other employees.
Personal
− Able to operate alone or as a team worker and leader with a strong, self-disciplined approach.
− Understands the "bigger picture" through a holistic approach
− Understands the need for profitability and long-term organisation growth.
− Understands focus on the topic in hand.
Previous Roles
1999 – Contract Accountant, Speedroll Industrial (Pty) Ltd, Krugersdorp, Johannesburg, South Africa
1997 – 1999 Contract Accountant, Rennies Travel, Johannesburg, South Africa
1993 – 1996 Owner/Manager, Stefanie’s Pharmacy, Brakpan Johannesburg
1985 – 1993 Owner/Building Contractor, W Jonas Building Contractor, Potchefstroom, South Africa
1983 – 1985 Financial Advisor, National Productivity Institute, Pretoria, South Africa
1980 – 1983 Financial Manager, Cullinan Engineering, Olifantsfontein, South Africa
1977 – 1980 Financial Accountant, Esteé Lauder South Africa (Pty) Ltd, Johannesburg, South Africa
1973 – 1976 Management Accountant, WJ Engineering (Pty) Ltd, Potchefstroom, South Africa
1972 – 1973 Systems Auditor, Gold Fields Mining & Development Ltd, Johannesburg, South Africa
Education & Qualifications:
− Honours Degree in Business Administration, Potchefstroom University, South Africa, 1977
− B Comm in Financial Accounting, Management and Cost Accounting, Business
Administration, Potchefstroom University, South Africa, 1973
− University Entrance Certificate, Potchefstroom Boys High School, South Africa, 1967
− Other external courses attended include Lead Auditor's course ISO 2001, Contracts for
Service Level Agreements, Novartis Leadership Development Programme