Experience

Fujifilm Healthcare UK

• United Kingdom
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance and Regulatory Affairs Executive

  • Mar 2018 - Present

  Management and maintenance of an integrated quality management system (QMS) ensuring compliance with EN ISO 13485, ISO 9001, ISO 20000, ISO 27001 and ISO 14001. Management of and lead auditor for the Internal Audit programme of EN ISO 13485, ISO 9001, ISO 20000, ISO 27001 and ISO 14001 systems covering x-ray equipment, mammography equipment, PACS systems and IVD. Respond to customer complaints and manage the Corrective and Preventive Action (CAPA) process using root cause analysis and problem solving methodologies. Appointed as a Radiation Protection Supervisor for Fujifilm Medical Systems, experienced in compliance to IRR 2017. Show less



Edward Peake Middle School

• United Kingdom
• 1 - 100 Employee

• Special Educational Needs and Disabilities Administrator

  • Sep 2014 - Feb 2018

  Responsible for generating and maintaining documentation for the SEND department. Ensuring compliance with current Government legislation.Liaison with outside agencies and parents.Specialist teaching for pupils with ADHD, autism and dyslexia.

• Teaching Assistant

  • Feb 2009 - Sep 2014

  Literacy support assistant - delivering specialist teaching programmes individually and in small groups.Carrying out pupil assessments. Whole class teaching.Class cover supervisor.



NCT Charity

• United Kingdom
• Non-profit Organization Management
• 100 - 200 Employee

• Postnatal Discussion Group Leader

  • 2004 - 2008

  Trained facilitator responsible for planning, preparing and delivering postnatal support courses to new parents. Trained facilitator responsible for planning, preparing and delivering postnatal support courses to new parents.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Analytical Chemist

  • 1997 - 2002

  • Led, trained and developed a team of scientists.• Analytical project leader for a late phase drug development project. Played a key role in the final development methodologies and handover to the manufacturing site.• Prepared relevant sections of NDA regulatory documents for submission to the FDA and the MAA for approval in Europe.• Participated in internal and supplier audits.

• QA Scientist, Worldwide Regulatory Affairs and Compliance (Secondment)

  • 2000 - 2001

  Responsible for developing, training and implementing new procedures.Delivering training in principles of GMP.Conducting GMP audits of suppliers, contract houses and internally.

• Analytical Chemist

  • 1995 - 1997

  Planned, managed and co-ordinated the project work of up to five analysts as analytical project leader on a late phase development project.



The Wellcome Foundation Limited

• United Kingdom
• Pharmaceutical Manufacturing

• Analytical Chemist

  • Aug 1990 - Jul 1995

  Analytical development in a variety of roles and departments within the development division. • Drug Analysis – developed methodologies for analysis of raw materials, intermediates and drug substance. • Consumer Healthcare – developed methodologies and conducted stability studies on newly developed over the counter products. • Toxicology Support – working to Good Laboratory Practice (GLP) standards to analyse substances used for toxicology studies. Analytical development in a variety of roles and departments within the development division. • Drug Analysis – developed methodologies for analysis of raw materials, intermediates and drug substance. • Consumer Healthcare – developed methodologies and conducted stability studies on newly developed over the counter products. • Toxicology Support – working to Good Laboratory Practice (GLP) standards to analyse substances used for toxicology studies.