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Certified Pharmaceutical Quality Auditor and Consultant

Technical Consultant #1670


Expertise

  • Certified Quality Auditor with 20 years experience of working with quality systems.
  • Trained in a number of ISO standards, Pharmaceutical Excipient GMP auditing and is an approved auditor for International Pharmaceutical Excipients Auditing (IPEA).
  • Experienced with ISO 9001, ISO 17025, ISO 14065 and Lexcel, Law Society's practice management standard.

Experience

Undisclosed Company, Director, 2008 - Present

  • A consulting firm servicing large companies and SME's who are either in need of complete QMS management or may require quality services.
  • Standards covered are ISO9001, ISO 14064, ISO14065, ISO17025, Lexcel and GMP for excipient manufacturers.
  • Implementation of the Lexcel quality standard to local solicitors.
  • Provision of desk assessments for applications to ISO14065 accreditation and VCS Temporary Accreditation.
  • Provision of GMP audits to pharmaceutical excipient manufacturers.
  • Project Manage ISO implementation projects from Gap Analysis to final award.

Arista Laboratories, Quality Assurance and Health and Safety Manager, Thames, U.K., 2006 - 2008

  • Laboratories providing a global specialty analytical service for the determination of analytes in tobacco and related products.
  • Led process to keep laboratory accreditation with success within a month of starting project.
  • Increased the company's scope of accreditation by 50 percent.
  • Initiated changes in the quality system that resulted in improved awareness and adherence to quality standards.
  • Oversaw the successful transfer from ISO17025:1999 to ISO 17025:2005.
  • Set up and running monthly training sessions covering QA issues, H&S issues and team-building exercises.
  • Set up and maintaining quality systems to ISP 17025 standard.
  • Re-initiating a series of internal audits to cover all aspects of the laboratory%u2019s quality system set up a system to track non-conformances, ensuring their timely and effective completion provide all staff with training on document and record control.
  • Initiating a program of calibration and traceability for laboratory services.
  • As Safety Manager, conducted risk assessments of all areas and processes within site and develop improved control measures.

International Specialty Products (ISP), Europe, 2000 - 2006

  • Held various positions: QA Compliance Specialist, QA Team Leader, Senior Chemist, Customer Care and Customer Care Specialist of this specialty chemicals manufacturer serviced all areas, pharmaceuticals, personal care, industrial and household.
  • Reduced raw material and finished stock stock levels in Europe over 50%.
  • Set up retest product procedure before expiration date, ensuring products availability in the marketplace, avoiding loss in sales and building of surplus stocks.
  • Attained ISO 9001/2000 certification for European operation.
  • Audited external analytical company for compliance against ISP needs then worked with firm to rectify all non conforming issues.
  • Responsible for performing both external and internal audits on behalf of the European organization in Europe and North America.
  • Liaised with regulatory team on initial REACH project.
  • Administered the European part of a global computerized inventory system.
  • Auditing of toll manufacturers' sites. Work with toll manufacturers to agree product specifications and ensure quality standards.
  • Developed and wrote departmental SOP's.

Morson International, Manchester, U.K., Electron Microscopy Technician, 1999

  • Responsible for the general running of the SEM laboratory.
  • Analysis of materials utilizing Electroscan 2020 Environmental Scanning Electron Microscope (ESEM) equipped with an Oxford Instruments ISIS EDX.
  • Maintenance of the ESEM, EDX and metallographical preparation equipment.

Rank Hovis MacDougall Technology, High Wycombe, U.K., Forensic Microsopist, 1998 - 1999

  • Forensic analysis of unknown components found in various foodstuffs involving the use ofimage processing software (Optimas and I Photo Plus), light microscopy, LEO VP435 Scanning Electron Microscope, Oxford Instruments ISIS EDX and FTIR.
  • Created and set up a database of glass samples for use in forensic analysis using FTIR, image archiving software, and quantitative elemental analysis by EDX.
  • Created and set-up a quality system for monitoring the efficiency of the departments forensic service.

European Superconductor Supply Ltd., Bishops Stortford, U.K., , Plant Chemist, 1997 - 1998

  • Set up QA protocols for all incoming and outgoing materials, set up and run analytical laboratory.
  • Set up XRF laboratory.
  • Responsible for the supervision of five members of staff.

Duracell Batteries Ltd. , Crawley, U.K., Senior Development Scientist, 1988 - 1997

  • Analytical service to Duracell's European facilities.
  • Set up and managed a well-equipped Scanning Electron Microscope laboratory, developed all methods and protocols relating to the analysis of battery materials.
  • Managed an atomic spectroscopy laboratory, AA & ICP, equipped with graphite furnace and hydride generation capabilities.
  • Developed new analytical test methods and updated routine methods according to ISO9001.

Whitgift School, Whitgift Foundation, Croydon, U.K., Laboratory Technician, 1987 - 1988

  • Maintained teaching laboratories, a preparation laboratory and a well-stocked animal room.
  • Prepared teaching materials for all levels up to GCE "A" level and aided teachers in the instruction of the students.

Honors & Publications


Credentials

  • Certified Quality Auditor: IRCA and American Society for Quality.
  • Certified Quality Auditor, American Society of Quality
  • Level 2 Certificate, CoSHH Risk Assessment, British Safety Council
  • Level 2 Certificate, Risk Assessment, British Safety Council
  • ISO 17025, A2LA
  • GMP Auditing for Excipients, IPEA, 2004: ISO 9001/2000 Lead Auditor, BSI
  • ZAF-PB/FLS training course, Link.
  • Analytical Electron Microscopy, University of Surrey.
  • Theory of Scanning and Transmission Electron Microscopy, Birkbeck College
  • ICP training course, Perkin Elmer.
  • First Aid at Work Certificate (St John Ambulance)

Languages

  • German Level 1 - University of Surrey

Academic and Professional Affiliations

  • Member of the Royal Society of Chemistry
  • Graduate Member of the Institute of Biology
  • Senior Member of the American Quality Society

Education

  • M.Sc Environmental Analytical Chemistry, University of London, U.K.
  • B.Sc Biological Sciences, Plymouth Polytechnic, Plymouth, UK
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