Certified Pharmaceutical Quality Auditor and Consultant

Technical Consultant #1670

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.

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.

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