A seasoned IT infrastructure quality assurance specialist who has excellent communication and organizational skills in all aspects of Pharmaceutical Regulatory Compliance and Quality Assurance, Document Management and Training.

Pfizer Global Research and Development (1992 to 2007)

Compliance Analyst (2001 to 2007)

• Document and Records Management
  • Prepared global strategy and operating plan and metadata schema for document and records management system
  • Led the global Document Control training and user support teams
  • Delivered Document Management training to IT colleagues in UK and Germany
  • Managed team of five Technical Authors to ensure the creation and review of all required SOPs, DQ, IQ, OQ and PQ documentation
  • Trained Regulatory Compliance staff in the review of IQ and OQ document sets
• Audit and Assessment
  • Developed an Audit and Assessment framework for use in the IT Infrastructure and in vendor audits
  • Used knowledge and experience of regulatory body inspections to ensure Infrastructure IT was ready for them, organising face-the-inspector training sessions
• Compliance Consultancy and Quality Assurance
  • Co-authored the IT Validation and Qualification framework for the IT Infrastructure
  • Coordinated QA support for many global IT Infrastructure projects
  • Provided Compliance Consultancy as regional point of contact for Germany
  • Provided Regulatory Compliance consultancy, support, detailed training and guidance to all technical teams in Sandwich and Germany
  • Provided 21 CFR 11 consultancy, advice and remediation support
• Compliance Training
  • Devised and managed an approach to Regulatory Compliance that would work within the IT infrastructure environment in an efficient and positive way. Implemented this approach across all teams, tailoring the approach to fit into the individual ways of working of each team
  • Created, rolled out and maintained the Regulatory Compliance training programme to all of Infrastructure IT at Sandwich, Amboise, and Fresnes. Promoted the approach across all Infrastructure IT sites globally

Production Integration Manager (2000 to 2001)

• Successfully championed use of Production Integration methodology, processes, tools and undertook presentations to a wide variety of audiences of varying backgrounds, seniority and global awareness
• Contributed to the further development of the Global Integration and Implementation Group and provided Production Integration Manager services to all business areas
• Reviewed existing processes within Application Infrastructure Group for resource management, implemented a standard policy for the Group, brokering consistent use of tools processes and classification of work activities

Implementation Co-ordinator – Application Infrastructure (1999 to 2000)

• Established the Smoother Implementation Initiative
• Developed the Smoother Implementation processes (Production Integration), methodology and tools
• Provided Implementation Co-ordinator services to all business areas and managed application retirement process
• Contributed to the establishment of the Global Integration and Implementation Group
• Assisted Y2K Project manager with tracking and QA requirements to ensure completion of all audits, assessments and testing

Application Support Co-ordinator – Clinical IT (1996 to 1999)

• Managed Clinical Support Plan Initiative
• Developed process for review of Support Plans and co-ordinated annual reviews
• Established Clinical IT virtual Support Desk
• Monitored and influenced Support Plans Technical Extensions Project
• Developed processes for the technical review of new clinical applications and for the decommissioning of redundant applications
• Encouraged effective global collaboration between support groups in the preparation of the support strategy for the Document Management and Production System
• Managed the support of the global Imaging Systems and Document Management systems

Team Leader, Business Support, Computing Department (1992 to 1996)

• Managed a team of four Business Support Analysts ensuring that the Research Division gained maximum value from the installed information technology and coordinated the user support service for 1,500 research scientists and staff
• Managed the external contracts for the provision of new desktop computer equipment and maintenance services
• Managed Projects to install PC applications servers for 1,500 PCs and install an image storage and electronic filing system using Excalibur EFS
• Contributed to the Large Document Production Project involved in the automation of the preparation and production of new drug applications throughout Pfizer in the UK and USA

BP Exploration (1978 to 1992)

• Technical Consultant, Information Technology (1991 to 1992)
• Head of Information Technology Customer Support (1989 to 1991)
• Information Systems Planner (1987 to 1989)
• Administration Supervisor, Contracts and Agreements (1984 to 1987)
• Senior Technical Assistant (Finance), Drilling Division (1978 to 1984)

Grampian Regional Council (1975 to 1978)

• Administration Officer

Family Business (1970 to 1975)

• Partner and General Manager

Inland Revenue (1967 to 1970)

• Tax Officer (Higher Grade)

Training

• Validating Laboratory Computerised Equipment & Systems Incorporating 21 CFR 11 Compliance (Life Sciences Division – IBC Global Conferences Ltd.)
• Exploiting the Benefits of Electronic Signatures (Henry Stewart Conference Studies)
• FDA Requirements for Electronic Records (Henry Stewart Conference Studies)
• Regulatory Compliance and Computer Systems (British Association of Research Quality Assurance)
• Selection Interviewing Skills (SHL)
• Negotiating and Influencing Skills (Pfizer Central Research)
• Advanced Service Level Agreement (Monadnock)
• PRINCE Project Management (Duhig Berry)

Membership of Professional Bodies

• Member of the International Society for Pharmaceutical Engineering (ISPE)
• Member of the Drug Information Association (DIA)
• Full professional member of the British Computer Society (MBCS)
• Chartered IT Professional (CITP)

Education and Qualifications

• BA (Open University), Degree completed in Computer Science (1980 - 1985)
• BSc (Aberdeen University), Mathematics, Chemistry, Geology (1965 - 1967)

Personal Details and Interests

• Married, excellent health, clean driving licence.

Interests

• Photography, music, computing / electronics, literature, gardening.