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CV

Ritchie Fraser

PROFILE

A competent and technically proficient IT Professional who has extensive experience in the highly regulated pharmaceutical and medical device industries. Experienced in large and small laboratory and QA based IT systems: installation, validation, maintenance and administration. Able to analyse complex problems and distil into simple concepts for use in delivering good solutions and training. A creative and analytical thinker with multifaceted business IT administration and support skills.

KEY SKILLS

  • Relationship builder with strong communication and influencing skills.
  • Multifaceted business IT support skills including installation, validation, documentation and implementation, system and user administration and support of Oracle based enterprise applications delivered using Citrix.
  • Organised system administrator with strong background in GxP systems, validation and change control.
  • Experienced in design, development and support of MS Access Database based applications using VBA.
  • Website developer and Programmer using HTML, PHP, CSS and MySQL
  • Experience of PHP, C, C++, VBA, Fortran, Shell scripting (Linux and Windows/DOS)

CAREER HISTORY

CooperVision Ltd, Ashford, UK May 2014 – To Date

Site Validation Lead:

Site Lead for Validation activities. Stewardship of the site validation programme and providing validation mentoring and support for validation leads and process SMEs when validating product realization equipment and processes.

Process Owner for change control.

Key Achievements

  • Modernized site validation system (SOPs, validation document templates) and practices to current good practice.
  • Validated existing ERP system
  • Updated engineering change process and delivered refresher / update training to 30+ change owners.

Quality IT Systems Administrator:

Systems Administrator for Quality Assurance IT Singlepoint system. User support and training. Introducer of best practice, technology and automation solutions.

Key Achievements

  • Modernized computer system validation practices to utilise GAMP 5.
  • Produced full validation document sets and executed for electronic QMS system modules

Marine Software Ltd, Ramsgate, UK June 2012 – May 2014

Systems Administrator:

Systems administrator responsible for provisioning and maintaining multiple servers, virtual and real using multiple operating systems.

Key Achievements

  • Upgraded eMail server
  • Refurbished training room, 8 new computers, utilizing Visualization technologies to provide multi operating system training environments
  • Maintained and supported office and development desktop and laptops
  • Developed web based viewing system for internal and external security camera feeds

Pfizer Ltd, Sandwich, UK July 1988 – October 2011

Systems Analyst (2009 – 2011):

Systems administration, 2nd and 3rd line user support and training for approximately 150 UK users for global file and Oracle based data capture and reporting systems delivered to users globally thought Citrix. Introducer of best practice, technology and automation solutions. Liaison between global business unit and corporate global IT departments.

Key Achievements

  • Presented a Case Study of Risk Based Validation, as an invited SME speaker, to 40+ industry experts at the UK GAMP (Good Automated Manufacturing Practices) forum (April 2011).
  • Introduced a “Risk Based” approach to computer validation in regulated environment for team of 15. Improving focus and consistency with a potential 3 fold reduction in process validation time.
  • Implemented a semi-automated process using MSDOS batch files for generating a report of archived study data used to demonstrate regulatory compliance. An average 10 fold reduction in time taken (30min to 3min) achieved.
  • Created a shared library of ~25 SQL queries using TOAD for team of 15, enabling more effective data mining across multiple Oracle databases, improving study and system maintenance reporting.
  • Implemented a semi-automated process using MSDOS batch files to generate statistical tables for scientific studies replacing manual process and reducing time taken to generate tables by 50%.

Senior System Administrator (2003 – 2009):

Responsible for application implementation, systems operation, maintenance and administration, user support and troubleshooting for all laboratory IT systems. Liaison between business unit and corporate IT departments.

Key Achievements

  • Managed the scheduling of outages of application servers, balancing need for business uptime requirement and corporate mandates for application and operating system security and functional updates. (2 x Citrix Metaframe application servers, 2 x Oracle database servers and 2 x file servers, 50 x lab based Windows XP machines)
  • Co-authored a comprehensive Quality Manual for validating computer systems in a regulated pharmaceutical environment: Balancing industry good practice (GAMP), regulatory requirements and Risk based approaches.
  • Installed, validated, maintained under change control a Waters Empower Chromatography data system (delivered through Citrix) for 60+ chromatographs and 150+ users in highly regulated pharmaceutical Quality Control laboratory.
  • Built suite of 12 business applications (using MS Access and VBA) for 150+ users to store, manage and report laboratory management information, leading to improved consistency of laboratory management through knowledge.
  • Chaired change management committee of 8 for 6 years. Ensuring continued regulatory compliance and reporting system and system support metrics to stakeholders. Resulting in 0 major findings in regulatory or internal audits.
  • Implemented an interface between enterprise data collection system and the companies global reporting system. Eliminating manual transcription of analytical results and QC checking, saving ~1000 man hours per year.

System Administrator (1994 – 2003):

Responsible for the installation, validation, operational maintenance and administration of two chromatography data systems and one stand-a-lone analytical instrument network in regulated environment. Networking and Data management of generated electronic data including server based and remote backup and archive. Development of IT solutions to laboratory based problems. (From concept through design, build, validation and implementation) using Microsoft Access, Excel, Word and other third party applications. General IT troubleshooting and IT Training for the department.

Key Achievements

  • Co-ordinated the Quality Operations department Y2k project. Zero negative impact on QC testing through transition from year 1999 – 2000 for GMP QC laboratories of 100+ users.
  • Co-ordinated the Quality Operations department sub-team (of 3) tasked with the evaluation and remediation of 30+ lab based IT systems, ensuring compliance with FDA regulation 21 CFR Part 11.
  • Successfully upgraded and re-validated the Quality Operations chromatography data system with 40+ chromatographs and 100+ users (LabSystems XChrom to Atlas) enabling continued use post Y2k.
  • Created automated spreadsheet to control and collect analytical balance calibration data, improving “Right First Time” performance and saving approx 6 man hours per week (no transcription or QC time required).

Analytical Chemist (1991 – 1994):

Working in the Active Pharmaceutical Ingredients laboratory in the Quality Control laboratories, duties included the analytical testing of bulk pharmaceutical medicines, training of new starters in laboratory practices (both testing and safety), technical troubleshooting, special projects and IT expert for section including system administration of the HP LAS chromatography system (HP 1000 minicomputer system) and the HP LABSAM based LIMS system.

  • Managed two HP 1000 minicomputer systems running RTE-A, QC laboratory data acquisition (LAS) and laboratory information management (LABSAM LIMS) for Quality Control department of 100+ users for 3 years. LAS and LABSAM written in Fortran 77.
  • Co-ordinated, configured and validated a LabSystems XChrom chromatography data system in GMP Quality Control laboratory of 100+ users in 4 months.

Laboratory Technician (1988 – 1991):

Working in the Bulk Finished Goods laboratory in the Quality Control laboratory, duties included the analytical testing of bulk pharmaceutical medicines

VOLUNTARY WORK

  • Designed, coded and built a complete web based booking and administration system for Kent Scouts International Jamboree 2013, 2017 and 2022. Collecting group and participant information, managing service team roles and numbers, invoicing and payment tracking of camp, catering, activity and creche fees for 500-1000 Scout and Guide group bookings (approx 7000 participants), Admin and finance reporting included.
  • Designed and built dynamic website for school of ~80 pupils utilising Linux, Apache, MySQl and PHP (LAMP). Increasing visibility of school in wider community & providing opportunities to celebrate their work. 50+ pages with >85000 visitors in 6 years.
  • Designed and built dynamic website using LAMP for colliery brass band. Advertising band concert venues, publishing programmes, including searchable index of music library and building community. 30+ pages with >85000 visitors in 6 years.
  • Led governing body of failing school. Implementing strategy & recruited new head: leading to improved attainment results and moving from “almost special measures” (Ofsted ’06) to “mostly good” (Ofsted ’10).
  • ex Explorer Scout Leader for the Hurricanes ESU (3rd Hawkinge Scout Group)

QUALIFICATIONS AND TRAINING

  • BSc (Hons) in Analytical Sciences, University of Greenwich
  • Higher National Certificate, Chemistry (HNC), Canterbury College of Technology
  • Ordinary National Certificate, Chemistry (ONC), Canterbury College of Technology
  • Foundation certificate in ITIL version 3
  • AAMI Process Validation

PERSONAL DETAILS

Driving Licence: Full and clean

Travel: No travel restrictions

Interests: Musician, Scouting, Genealogy and all things Tech.