Summary

I am a hard working, experienced person who specialises in compliance, especially computer system compliance within the Pharmaceutical industry. I have over seven years Pharmaceutical experience, more than five of these in IT. I am multi-skilled, responsible, and able to tackle complicated tasks with a great deal of autonomy.

I expect to gain my results for my Masters degree in Computing for Commerce and Industry through the Open University during 2006.

Vital Statistics

DOB: 25 July 1977

Married, 2 Children (4 year old and 2 year old girls)

Full Driving License

UK Passport Holder

Employment

2002-Present

The Analytical Sciences department of a top 10 Pharmaceutical Company

I am the computer specialist for the Analytical Sciences department at Alnwick. This job involves:

• Being the worldwide User Support leader for an Analytical Chromatgoraphy Data System across 6 sites and four countries. I am also the administrator for my local site. This involves deployment and validation of the software, all documentation, user training and co-ordinating support for other sites. I also interact closely with the vendor on resolution of problems and new functionality.
• Being the site administrator for a worldwide distributed LIMS system, based on ThermoLabs Sample Manager, including all local validation, training, system maintenance and administration.
• Being responsible for the design, implementation, validation and support of new IT systems and projects in the department. Past projects have included a chromatography data system based on Dionex Chromeleon, supporting over twenty instruments and fifty users, a file management and archiving system and 21 CFR Part 11 compliance.
• Being the first point of contact for all IT and / or regulatrory compliance and validation issues within the department, this involves Policy and Procedure writing and review, Part 11 compliance, dossier submission and inspection audits as well as liasing with vendors, contractors and colleagues around the world.
• Managing the day to day actions of the metrology and research stability studies departments and staff (two full time employees).

2001-2002

A Small Speciality Pharmaceutical Manufacturer

My job involved responsibility for regulatory activities and 1 st and 2 nd line helpdesk activities:

• I was involved in managing and working in several major projects, using PRINCE methods, these included IT support for a QC Lims system, a document management system and large hardware upgrades.
• I was in charge of a project to ensure the compliance and validation status of all IT systems and equipment in relation to all applicable regulatory, starting with the validation status of the network infrastructure. This project was deemed highly critical, as it would be in the first phase of an FDA inspection of the company towards an NDA.
• Helpdesk activities and problem solving for the 600+ users on site over a range of office, production and laboratory software on various platforms.
• Training of users in new or existing software and deciding on future course of IT development for end users.

1999-2001

A Small Speciality Pharmaceutical Manufacturer

My main role was QC testing of in process and final product samples:

• I ran assays, chromatography, elemental and chemical testing. All testing is carried out according to GxP and other relevant guidelines and BPL procedures.
• I was responsible for validity of all data I produced or reviewed.
• I was involved in method development and in validation of methods and equipment, particularly the computer based aspects.
• I also acted as the IT specialist to the method development team.

1997-1998

A Major Lubricants Manufacturer

During my year long industry placement I was responsible for the testing of competitor samples. I worked according to various standards including ISO-9001, COSHH and GLP.

I also developed a piece of analytical software using Visual Basic, designed to work in conjunction with FT-IR spectrometers, which is now in use at Castrol sites worldwide.

Qualifications

Sept 1999 – Present

Postgraduate diploma / MSc in Computing for Commerce and Industry

Open University

A Masters degree in Computing, from the Open University totalling 1,800 hours of study. The course is modular and has included modules on Project Management, Software Engineering, Quality Systems, Relational Databases and Object Orientated engineering techniques

The Masters course is accredited with the British Computer Society. The Project Management module is accredited with the Project Management Association and is equivalent to the ISEB Certificate in Project Management. The Managing Quality module is recognised by the Institute of Quality Assurance.

The modules above form the diploma in Computing, I intend to convert this into the MSc by 2006 by completing a nine month research project, which is titled ‘Application Development Methodologies within the Pharmaceutical Industries'.

1995 – 1999

Aston University

2ii BSc (Hon.) in Applied Chemistry

Final year project: 'Interaction of Vitamin E (alpha-tocopherol) and Bis-Hindered Phenols in an Oxidising Hydrocarbon Substrate'

Placement year with Castrol International Industrial Analytical section 1997-1998 (see Employment History)

• 4 A Levels in Chemistry (D), Physics (D), Maths (D) and Technical Drawing (B)
• 10 GCSE including Maths (C), Science (A A), Art (B) and Computing (C).

Other Qualifications

I have completed courses on setting up, administrating and running a Microsoft NT based network. These qualifications used to form part of the Microsoft Certified Systems Engineer (MCSE) for Windows NT 4.0.

I have also completed a course on backup, restore and disaster recovery procedures using the Computer Associates ‘Arcserve' software system.

I have attended several courses and symposia around the area of quality and compliance within the Pharmaceutical industry and I have also attended several international conferences, both internal and external to the company. The last conference I attended was Pittcon 2005, held in the US.

Relevant Professional Experience

I am extremely computer literate and have extensive skills in set-up, running and administration of many kinds of systems including:

• Specific Pharmaceutical Applications, covering areas such as Laboratory Information Systems, Electronic Data management, Chromatography Data Systems, Electronic Document Management Systems and Enviromental Management Systems.
• OS Platforms such as Windows 9x, NT and 2000 and Linux.
• Desktop software such as Internet Explorer, Microsoft Office, Lotus Notes, Visio, MS Project and Photoshop.
• TCP/IP LAN / WAN network design, installation and maintenance.
• Database systems such as Oracle, Lotus Domino and MySql.
• System administration tools, such as NT Policies, Norton Disk utilities and remote access / installation software.
• Disaster Recovery and Security, including Checkpoint firewall/VPN, McAffee and Sophos anti virus software, Arcserve backup software and disaster recovery and security planning.
• HTML Coding both freehand and using packages such as Macromedia Dreamweaver. Examples of my web design work can be seen at www.paulhurley.co.uk.

I am experienced in Project management including use of the PRINCE 2 methodology. I also have many business orientated skills including Training and Presenting, Management and co-ordination of small and medium Teams of people and I regularly use these skills in my work.

Volunteer Experience

During my time at Aston University I volunteered within the Guild of Students. I was very much involved in the Entertainments Department, organising and running evening events where I often was in charge of teams of up to twenty volunteers. I was also elected to the Societies Committee, which dealt with the 35 non-athletic clubs and controlled a budget of £8,000. These jobs helped me develop my leadership, organisation and project management skills, and learn how to negotiate and deal with groups of people with differing ideas and goals.

Hobbies

In my leisure time I enjoy playing with my daughters, web page authoring, computer repair, mountain biking, swimming, reading and cinema.

Proffesional Memberships

I am currently a member of the Royal Society of Chemistry and the British Computer Society. I am active in several on line communities involved in IT in regulated industries.