Senior Manufacturing Quality Specialist
Since August 2014
Quality role dealing with raw materials and batch release.
November 2012 --- August 2014
Compliance Specialist responsible for continuous improvement on quality and compliance functions within medical grade plastic manufacturing to ensure ISO 13485 and 9001 compliance; carry out validation of equipment; plan and supervise staff for the manufacture of IVD grade products.
November 2011 --- November 2012
In Vitro Diagnostic medical grade plastic moulding; manufacturing specialist; managing production of IVD products; QA checking and authorising production; continuous improvement; customer liaison and face to face contact.
Lead Analytical Chemist
January 2010 --- December 2011
A hands-on quality role supporting cross functional teams to generate complex protocols, reports and technical memorandums to support production schedules and regulatory compliance; led the laboratory support for plant cleaning and validation testing; provided detailed knowledge of equipment and processes.
Lead Cleaning Validation Analytical Chemist
January 2000 --- January 2010
Provided expertise and laboratory support for plant cleaning. Liaised across departments providing technical knowledge, deciding swab sampling locations and setting validation limits. Advised and inspected equipment to enable production to commence. Generated complex protocols, reports and technical memorandums. Developed and validated methods as part of longer term projects to meet changing production schedules.
August 1992 --- January 2004
An analytical role involving specification review and method development and validation. Implemented new instrumentation/techniques into routine QA testing such as NIR and Laser Particle Size analysis.
1st class Honours in Chemistry from Mid-kent College in 1992