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Director and principal
Consultant
______________________________________________________________________
I have
presented to conferences in many countries under the auspices of
ISPE and PQG on topics including Validation of Pharmaceutical
Artwork Origination, Laboratory Instrumentation, Good Validation
Practice, and ERP systems.
Skill set
Expert in
Validation of computer systems and interfaces in Pharmaceutical
companies with over 10 years high level consulting experience
over full lifecycles.
Project,
Programme Management and Control of Validation activities
GAMP 4/5
consultant and active member of ISPE (International Society of
Pharmaceutical Engineering).
European
Pharmaceutical GDP (Good Distribution Practice) directive
compliance experienced in implementation of Multi Market
Satellite Distribution Processes.
Pharmaceutical
GxP trainer.
US FDA 21CFR part
11 compliance assessor for electronic records and signatures.
Business process
engineering and process development.
Procedure
development and authorship.
Trained and
experienced auditor. Has functioned as lead assessor and managed
audit processes.
Wide experience
of Quality and Validation Management and methods including TQM,
Six Sigma, Systems Security, continuous improvement, audit, BPR,
etc.
Mentoring,
training and establishment of QA/validation culture.
SAP process
development and configuration support and knowledge transfer.
Oracle, JD
Edwards and BPCS ERP systems validation management.
SAP ERP certified
consultant in MM.
Validation of
laboratory instrumentation, artwork origination processes and
printing systems.
Test management
including Test Script development, methods, management, review,
approval, incident control and reporting.
Support to sites
for go-live and post implementation review.
Hardware
compliance and certification to European CE regulations.
Extensive
experience in 8 full project lifecycles, and partial involvement
in several others.
MS Office
proficient, MS Windows 95/98/ME/XP technical expertise and PC
construction.
Network and
server design and configuration
Chartered
Engineer (C.Eng), Member of IEE (MIEE), Member of CQI (MCQI)
formerly IQA, Member of ISPE
Secretary of
Phamaceutical Quality Group (PQG) within the CQI (Chartered
Quality Institute)
March 2007 –
Date
Full lifecycle
project and compliance management of development and deployment
of systems to upgrade JDE IT and Business systems continuity and
disaster recovery. This project employed specialist mirroring
and server management software (iTERA).
Project and
compliance management of software development project to deliver
automated invoice systems for Export Finance functions of
[snip].
Test Management
to ensure technical and regulatory compliance.
October 2006
– March 2007
Validation
Management of [snip] Supply and Distribution ERP system
involving compliance audit, review and improvement of governance
documentation for Export Finance Trading Partner Operations.
Consultancy on business process improvement and support methods
development. Validation support to change control processes and
the refinement of support processes.
Compliance
support to new project inception phases including resource
estimation, compliance determination, proposal of deliverables
and assistance to project management in the presentation of
projects for budgetary approval.
April 2005 –
October 2006
Validation
Manager for distribution systems for [snip] outsourced satellite
distribution centres in Europe and Middle East and systems
development to support GxP order processing throughout the
lifecycle of a major capital project. Managed validation
resources and developed lean techniques to ensure optimal
business benefits and compliance. Supported transition and post
implementation validation activities. Involved travel to site to
manage validation activities and intensive test operations.
Project Manager
for evaluation and pre-validation assessment activities with
Intercytex for proposed ERP system including package selection
and requirements analysis phases.
Apr 2004 –
April 2005
Pharmaceutical
compliance review (audit) of six major middleware projects for
[snip]. Validation Management of major middleware and
infrastructure project for [snip] including transition to
outsourced suppliers of significant supply chain business
processes. Validation Management of Statistical Tool for
laboratory application worldwide.
Validation
Management and Quality Systems development for outsourced
Pharmaceutical Artwork Origination suppliers [snip] and InTouch
Group. This included assignments in the US and UK.
Mar 2003 –
Apr 2004
Validation Management activities for global SAP HRIS project in
Amersham plc. Successfully managed all validation activities
leading to roll out to Amersham sites in Sweden, UK, Ireland,
France, Germany, Italy, Spain and Portugal. This included USA,
Canada, Japan and China. Delivered in depth technical analysis
of the system to identify all GxP relevant components and risk
analysis for Electronic Records and signatures to US FDA 21 CFR
Part 11.
Negotiated, tendered for and carried out an in depth analysis of
computer systems and methods in use at [snip], Birmingham.
Delivered a detailed proposal for the development of systems and
methods for [snip] to enhance their capability in Pharmaceutical
Artwork Origination and packaging design. Presented to [snip] at
International Chief Executive level to advise on strategy for
systems capability to meet pharmaceutical industry requirements.
Jan 2002 –
Mar 2003
Validation
Management of global SAP HR and training/competency system for
[snip]. Validation planning, test management, GxP assessment and
ERES assessment of core design and individual site
customisations. High level consultancy to Amersham PLC on
procedures and methods. Placed and managed Testing Manager.
[snip]
Near Infrared laboratory instrumentation validation management
for global roll out. Supplier audit (Perkin Elmer) and
resolution of issues especially around 21CFR part 11 compliance.
Regulatory
compliance management for [snip] knowledge management system.
Validation management and compliance assessment for a number of
small projects and systems. This included automated inspection
(artwork imaging) systems and computerised packaging systems.
[snip] SAP supply
chain European implementation to European GDP (Good Distribution
Practice) directive based in Verona, Italy. Validation
management of core design and European roll-out. GxP assessment
and ERES assessment of design for European regulatory framework.
Delivered factory
wide systems compliance audit and validation training for
Polpharma, Poland.
Jan 2001 – Dec
2001
[snip]
High level
consultancy on Electronic Records and Signatures compliance and
inspection readiness for corporate projects. Development of
methods for support transition and the maintenance of validation
status.
Validation
management, review and reporting for [snip] global LIMS (HP
ChemLMS) project. Review of inspection readiness of LIMS project
involving cross-phase and multi site review of project
deliverables.
Validation
Management of a number of critical application developments
involving Verona Italy and UK operations. Critical applications
for laboratory Near Infra Red operations and interfaces and
printing automated inspection equipment. These projects were
high profile and had to solve issues arising from inspections by
the authorities and product recall situations. Liason with
suppliers to ensure the software products were designed to
conform to the regulations.
Jan 2000 – Dec
2000
[snip]
ERP
Programme
· Validation
support of Business Process definition and documentation,
knowledge transfer and mentoring for blueprint and requirements
specification phase.
·
Validation support for prototyping and configuration phases.
·
Participation in leadership of project scope determination and
conceptual design for SAP R/3 Global ERP Programme.
·
Responsible for Validation planning and project planning for the
Global ERP Programme. Establishment of project methodology.
Leadership and main task of creating and agreeing Project Plan.
·
Responsible for development of Gap analysis, AS-IS and TO-BE
modelling and pre-design system to satisfy both [snip] and ASAP
methodology requirements.
·
Management of the [snip] ERP Validation Department in the
interim period between the end of MRP implementation and the
commencement of a full ERP implementation. Responsible for
department resource, budget and tasks. Creation of departmental
Work Breakdown and Work Packages.
·
Creation of procedures and QMS trainer.
[snip] early 1998 –
end 1999
Principal
Consultant – external contracts
SAP R/3
Implementation for [snip] MRPII Programme.
·
18
Months SAP MM and validation senior consultant with key role in
demanding and urgent programme. Project driven by critical
regulatory and business deadlines.
·
Project and technical critical issues management and resolution.
·
Project validation planning and development of procedures and
methods.
·
Leadership of major project phase of system testing involving
100 end to end business scenario tests involving about 250
persons and carried out successfully to severe time constraints.
Oversight of the development of MM related testing activities.
Responsible for business process development (BPR) and
integration methods design.
·
Leadership of successful cut-over verification activities at
[snip] Singapore facility prior to product release in order to
prove safe SAP system operation (PQ).
Other Consulting
activities
·
Project Management of validation activities for Sample Manager
LIMS validation at Eli Lilly, Speke Operations. Definition of
project from Validation Master Plan, Test Plan, Protocols and
Test Scripts. Technical consultancy in the strategy and method
to be adopted for validation.
·
Significant contribution to NAPP Pharmaceuticals Oracle/GEMMS
implementation in terms of audit of FDS (Functional Design) and
development of challenge test and millennium compliance test
validation plans and methodologies. Also the review of test
results and the production of test reports.
·
Project management of validation tasks for [snip] (IAS) BPCS
implementation for 6 months prior to cancellation of the project
due to issues outside of MIS control. Assisted in the
development of validation strategy and methodology. Leadership
of and participation in a team writing and executing test
scripts to demonstrate compliance with relevant statutory
requirements (GMP). Significant involvement with subcontract
provider of software to develop and qualify a vital subsystem.
[snip] (Time Computers) 1996 - end 1997
Quality
Manager
·
Overall group Quality Management responsibility for computer
manufacture, sales, helpdesks, service and technical. Emphasis
on the engineering and development of internal business
processes. Function as group wide internal consultant and change
catalyst.
·
Management, selection and development of all quality related
staff (approx 30).
·
Established and developed ISO9001 Quality System. Reformed
entire Quality System, re-engineered business processes and
gained ISO 9000 registration for newly formed subsidiary VMT
Limited in 6 months.
·
Initiated effective supplier QA monitoring. Managed internal
audits.
·
Set
up EMC (Electro-Magnetic Compatability) compliance test
facility. Recruited staff, established methods and developed
compliance engineering.
·
Managed the millennium compliance programme.
·
Responsible for the resolution of technical problems with
suppliers and across internal teams such as marketing, design
and manufacture.
[snip] (Subsidiary of Boots
plc) 1994 - 1996
Quality
Manager
·
The
management of continuous improvement of [snip] branded
electronics, tools, security products and automotive replacement
parts.
·
Development of in-house technical standards and specifications
for the development and assessment of Own Branded merchandise.
·
Management of technical assessment and compliance of products to
EC legislations for EMC, Low Voltage Safety, Machinery and
Chemicals, necessitating a working knowledge of all relevant
standards.
·
Control of retail printing, labelling and instructions for
regulated merchandise.
[snip] - SCADA manufacturer (GE – USA) 1989 - 1994
General
Manager
·
Promoted with responsibility for all company operations
including manufacturing, purchasing, stock, shipping, production
test, production engineering, administration. The company
maintained contracts with major international blue chip
companies and utilities.
·
Project Managed Implementation of MRP/ERP systems and surface
mount electronics assembly. Particular detailed involvement with
MRP/ERP system configuration and roll out.
Quality
Assurance Manager
1984
- 1989
·
First quality appointee in start-up company, AFE Displays
·
Took the company from having no quality system to achieving
ISO9001 with a commendation for high levels of motivation for
quality
·
Built quality department and developed other strategic roles
including procurement and design quality of electronics hardware
and software
·
Developed QA methods including software design methodologies and
validation, reliability stress screening, supplier quality
assurance, Zero defects, TQM, and a focus on customer
satisfaction
·
High profile customer facing role in the liaison with major
export accounts to manage quality planning and improvement.
[snip]
1980 - 1984
Quality
Engineer
Education
4 A Levels, 9 O
Levels Plympton Grammar School
Degree in
Electronic Engineering Liverpool University
Professional Qualifications
BS5750 (ISO9000) Lead Assessor Portsmouth Management Centre
Software Quality Assurance Systems
Dunchurch Management Centre
IQA Quality Management Course
Coventry Technical college
AFE Technologies senior management development programme
Boots Retail Management development programme
Advanced Presentation Techniques
Granville Technology Training
Train the
Trainer
Granville Technology Training
BPCS
training
SSA Training Centre, Frimley
SAP MM Academy 3.x, 4.x SAP
Academy, London
Member of IQA, Member of IEE, Chartered Engineer.
Personal
Details
Leisure Interests:
Date of Birth
15.06.58 Travel and Portrait
Photography
Married with 1
son Distance running
competitions
British, Excellent
health
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