Paul Smith

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Quality Leadership and Strategic Direction
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Paul is an enthusiastic change agent with a passion for achieving success through helping people fulfil their true potential. A natural networker, he integrates his cross-functional training, technical and leadership experience into his day to day work. Balancing people, business and strategic objectives are a core part of his team working and facilitation style. He has a skill for understanding and simplifying complex information and an ability to express it in presentations, publications, training and workshops so that others can learn and apply the information. This accelerates knowledge transfer / training, builds confidence, re-enforces change, speeds up decision making and supports competitor analysis and strategic focus.

Paul Smith’s Specialties:

★ Analytical Technology
★ Application of NLP
★ Change Management & Cultural Change
★ Coaching and Developing High Performance Teams
★ Designing & Facilitating Experienced based Workshops and Learning
★ Interpretation of Regulatory and Quality Guide Lines
★ Problem Solving and Decision Making
★ Sales Training & Customised Presentations
★ Strategic Management & Leadership
★ Quality and Compliance
★ Validation / Qualification – DQ / IQ / OQ / PQ

Paul Smith’s Experience

European Validation and Compliance Manager

PerkinElmer LAS

(Public Company; PKI; Biotechnology industry)

September 2006 — Present (3 years 3 months)

Developing and Implementing Compliance, Quality and Validation Services

Consultant to customers externally and internally, providing compliance, strategic direction, technical and management support while developing and promoting the services provided

• Designing and Integrating Quality and Validation Services
• Facilitating Dynamic Growth of Multi Million $ Brand
• Promotion and Development of OneSource Brand
• Regulatory Interpretation and Trend Monitoring
• Sales and Marketing Through Publications and Seminars
• Training and Coaching of Customers and Engineers
Consultant Lecturer

University of Greenwich

(Educational Institution; Higher Education industry)

February 2006 — June 2006 (5 months)

Technology Transfer Workshops With Teams of BSc Students

Took final year BSc students through significant learning and self-awareness in novel experience based workshops, putting back 17 years cross functional knowledge and experience

• Coaching, Facilitation and Belbin / NLP Team Profiling
• Kepner Tregoe – Problem Solving, Decision Making
• Knowledge Transfer, Teamwork, Project Management
• Project & Activity Driven Experience Based Learning
Owner and Director

Tera Solutions Ltd

(Pharmaceuticals industry)

December 2002 — December 2005 (3 years 1 month)

Consultant in Analytical Science, Quality Systems and Bespoke Training.

Set up and ran Consultancy Business, developing and exploring commercial opportunities with an entrepreneurial application of pharmaceutical experience

• Science, Management and Quality Consultancy
• Consultant Lecturer (PAT, Quality, Regulations)
• Customised Training and Coaching
• UK Business Manager for ISO 17025 Laboratory
Quality Operations Manager

GlaxoSmithKline

(Public Company; GSK; Pharmaceuticals industry)

April 2000 — August 2002 (2 years 5 months)

Laboratory Operations Manager for Pharmaceutical Manufacturing Site.

Lead a busy Quality Assurance Laboratory with +70 people through significant change, providing strategic leadership and technical direction, through downsizing and uncertainty

• 50 % Reduction in Test Times (through Lean Sigma)
• Involved in Analytical Harmonisation After GSK Merger
• Managed Department Equipment Budget
• Prepared and “Fronted” Laboratory Audits (FDA ... etc)
• Supported LIMS and CDS Corporate Upgrade Projects
• Targeted OOS Driven CAPA Improvements
Team Manager

GlaxoSmithKline

(Public Company; GSK; Pharmaceuticals industry)

November 1997 — April 2000 (2 years 6 months)

Managed Batch Quality and Quality Control Testing Teams and Projects.

Held Team Manager roles with progressive levels of technical, product and people responsibilities, working at the “sharp end” of a busy Quality Assurance Laboratory

• Coached and Mentored less experienced Managers
• Implemented JIT Batch Release
• Managed QC Analytical Testing Teams
• Ran 24 Hour Analytical Support Teams
• Responsible for QA Y2K Implementation Projects
• Wrote Quality Reports summarizing Production Trials
Technical & Project Support Manager

GlaxoSmithKline

(Public Company; GSK; Pharmaceuticals industry)

September 1989 — November 1997 (8 years 3 months)

Managed Projects and Teams in Matrix Environment.

Held technical and team leader roles, working in Quality Assurance and New Product Introduction to support API manufacturing, customer complaints and Technology Transfer

• Analytical Method Development, Validation and Transfer
• Chemometric Batch Quality Screening by NIR and FT-IR
• Lead Trainer in (FT-IR), Policy to Training Programs
• Presented Trace Cross-Contamination Strategy to FDA
• Production secondment for Bio-Process Commissioning
• Ran Site HPLC Department, Managing LIMS and Robots
• Set up New Analytical Laboratory, including Validation
Scientist

SmithKline Beecham

(Public Company; GSK; Pharmaceuticals industry)

December 1985 — September 1989 (3 years 10 months)

Provided Specialised Service to Support Drug Discovery

Working as part of a team confirming proof of structure for novel drug compounds and investigating drug/protein/lipid interactions, as well as quantitative FT-IR polymer analysis

• Applied FT-IR to Research Programs
• Completed MSc Thesis
• Recording & Interpreting FT-IR and FT-Raman Spectra
• Trained Scientists in Optimal use of Infrared

Paul Smith’s Education

PPD Learning Ltd

Neuro Linguistic Programming , NLP , 2006 — 2008

Activities and Societies:

Post Master Practitioner
• NLP Mastery in Executive Coaching - Julian Russell
• NLP and Naturally Great Decisions - Charles Faulkner
• NLP and Teamwork - Simon Horton
The Northern School of NLP

Neuro Linguistic Programming , NLP , 2001 — 2008

Activities and Societies:

Practitioner, Assistant & Master Practitioner
• Derek Jackson, Fran Burgess
• Robert Dilts, Steve Gilligan
• David Gordon, Judith DeLozier
• Denis Bridoux, David McWhirter
Birkbeck, U. of London

MSc , Analytical Chemistry , 1987 — 1989
University of Bradford

BSc , Chemistry , 1981 — 1985

Additional Information

Paul Smith’s Websites:

My Company

Paul Smith’s Groups:

Member of Society of Quality Assurance
Member of the Chartered Management Institute (MCMI)
Chartered Chemist (Chem MRSC - RSC)
Chartered Scientist (CSci - The Science Council)

Executive Suite
American Society for Quality
Chartered Management Institute Network
Business Intelligence Group
Learning, Education and Training Professionals Group
! Sales Best Practices
Laboratory Professionals
Lean Six Sigma
Pharmaceutical Discussion Group
International Coaching Network
eMarketing Association Network
NLP Coaching Group
FDA Regulated Industries Group
Knowledge Management Experts
Quality Experts
Computerized Systems Validation (1000+)
NLP (Neurolinguistic Programming)
Software Testing & Quality Assurance
Advanced Innovation Methods (AIM)
JibberJobber - Career Management
Biotech & Pharma Professionals Network
Organizational Change Practitioners
Customer Experience Management
Public Speaking Network
ValidationExperts
Customer Analytics Group
GSK Employees and Alumni Network
NLP Master Practitioner
Medical Device Professionals Network
Business Improvement, Change Management & Turnaround
Belbin Team Roles
Process Analytical Technology
CompliancEX
PerkinElmer Employees and Alumni
Accelerated learning
Creative Solutions
Innovation RainMakers(r)
Metacognition: "Learning to Learn"
Lean Enterprise United Kingdom
Lean Quality Systems
BELBIN Leadership Profile
Excel Spreadsheet Authors
FDA-RTF Solutions:483s,Warning Letters,CAPAs,Risk Assessment/Mgt,Audit,Remediation,QbD,Lean 6 Sigma
Pharm Tech Europe
Computer Validation CONTENT
Kaizen
Performance Testing
LInked:HR - HR Leadership
Linked:HR - Organization Development & Training
Organisational NLP
The Psychology of Creativity

Paul Smith’s Honors:

Targetted Publications to Support Business Growth:

1. “20th Anniversary Special Feature Qualification and Validation”

PTE, Advanstar Publications, December 2008

http://www.ptemag.com/pharmtecheurope/author/authorInfo.jsp?id=48253

2. “The Science of Compliance”

LC-GC The Column, Advanstar Publications August 2008

http://chromatographyonline.findanalytichem.com/lcgc/The-Science-of-Compliance/ArticleStandard/Article/detail/542454?ref=25

3. “Laboratory Compliance:Making The Grade”

Laboratory News, September 2008

http://www.labnews.co.uk/laboratory_article.php/3737/5/laboratory-compliance:-making-the-grade

4. “Trends in Analytical Instrument Qualification”

BioProcess International Vol. 5, No. 9: pp 30-38 (October 2007)

5. “Benefiting From Laboratory Equipment Validation Services”

SP2, August 2007

REPRINTS AVAILABLE ON REQUEST

Paul Smith’s Contact Settings

Interested In:

career opportunities
consulting offers
job inquiries
expertise requests
business deals
reference requests
getting back in touch

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Paul Smith’s Summary

Paul Smith’s Specialties:

Paul Smith’s Experience

European Validation and Compliance Manager

PerkinElmer LAS

Consultant Lecturer

University of Greenwich

Owner and Director

Tera Solutions Ltd

Quality Operations Manager

GlaxoSmithKline

Team Manager

GlaxoSmithKline

Technical & Project Support Manager

GlaxoSmithKline

Scientist

SmithKline Beecham

Paul Smith’s Education

PPD Learning Ltd

The Northern School of NLP

Birkbeck, U. of London

University of Bradford

Additional Information

Paul Smith’s Websites:

Paul Smith’s Groups:

Paul Smith’s Honors:

Paul Smith’s Contact Settings

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