Experience

Torbay Pharmaceuticals

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• ISO Manager

  • Feb 2018 - Present



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Complaints Investigator

  • Feb 2017 - Jan 2018



GlySure Ltd

• United Kingdom
• Medical Equipment Manufacturing

• QA Specialist

  • Feb 2012 - Jan 2017

  Originally employed as a Microbiology and QC Technologist to set-up the QC and Microbiology testing laboratories. This began with designing the floorplans then moved through installing and validating equipment, sourcing suppliers, implementing procedures and recruiting staff to run the areas. This role changed once the initial testing laboratories were running smoothly to a Quality focus. Responsibilities include managing the Quality Control and Microbiology teams, final batch release for human use, phantom recalls / product traceability, sterilisation control and validation, continuous improvement and risk assessments. The current emphasis of the role is on Quality Systems and to date the non-conformance and CAPA, Change Proposal and Batch Release Systems have all been redesigned and rebuilt to reflect the needs of a rapidly growing company, the requirements of lean six sigma and the transition to FDA approval. An integral part of the job is auditing with monthly internal audits as well as regular supplier / external audits and hosting regulatory audits on a six monthly basis. Show less



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Executive

  • Jan 2007 - Jan 2012

  Working in the Quality Assurance Compliance Department of a multi-national contracting manufacturing company. The company offered a diverse range of products from tablets through to sterile injectables supplying these to over 15 major Pharmaceutical Companies. Based within the Manufacturing Department this role was the first point of contact for the Production, Microbiology and Engineering Departments for Quality issues. Additionally the role held responsibilities for Annual Product Reviews, approving batch records and ensuring compliance with Good Manufacturing Practice across the site. Show less



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Microbiologist

  • 2000 - 2005

  Working for an international pharmaceutical company at a sterile manufacturing site. This entailed responsibility for the Microbiological testing of utilities, equipment, raw materials and products to corporate and regulatory standards. In 2002 and the role changed with an increase in responsibility to encompass validation. This included an extensive range of projects including utility, method, equipment and disinfectant validation from the design phase through to completion. Working for an international pharmaceutical company at a sterile manufacturing site. This entailed responsibility for the Microbiological testing of utilities, equipment, raw materials and products to corporate and regulatory standards. In 2002 and the role changed with an increase in responsibility to encompass validation. This included an extensive range of projects including utility, method, equipment and disinfectant validation from the design phase through to completion.



Northern Foods

• Food and Beverage Manufacturing
• 100 - 200 Employee

• Food Microbiology Technician

  • 1997 - 2000

  Working at a busy central testing laboratory that was UKAS accredited for all tests; including the handling of ACDP Category II pathogenic micro-organisms. The large number and variety of samples received ensured that Good Laboratory Practice and Quality were an essential part of every task undertaken. Working at a busy central testing laboratory that was UKAS accredited for all tests; including the handling of ACDP Category II pathogenic micro-organisms. The large number and variety of samples received ensured that Good Laboratory Practice and Quality were an essential part of every task undertaken.