a highly experienced quality professional working within stringently regulated Pharmaceutical and Medical Device Manufacturing environment. a good understanding of GMP and iso standards (9001 and 13485) with a wide range of skills and knowledge within quality roles based around laboratories and Manufacturing. a practical approach to qms, validation and safety. seeking a challenging and demanding technical role within quality or Manufacturing of Diagnostic or Pharmaceuticals that will develop my knowledge and skills further. specialist skills and knowledge • working within a qms structure with detailed knowledge of GMP and quality standards (including ISO 9001 and 13485 standards). • internal and external Auditing. • batch release and generation of certificates of conformance. • process and equipment validation activities including generation of associated Documentation. key skills • ability to work effectively in a team and independently using own initiative. • identifying, Troubleshooting and solving technical problems (Root Cause Analysis and capa). • self-disciplined and able to plan, organise and prioritise projects. • leading internal audits (quality, 5S and safety). • effective Communication at all levels, from shop floor to senior management. • creating and developing documents and systems to improve efficiency and Compliance. • extensive experience in a wide range of chemical and physical Analytical techniques (e.g. HPLC, hs/gc, tlc, UV, ir, nir, ce, aa, icp, dissolution Testing, sympatec, malvern). • Expert knowledge of Cleaning Validation and particle size. • analytical method development and validation in various techniques including HPLC and gc. • Project Management across multi-disciplinary teams. • use of manual and electronic document control systems in support of qms • 6 sigma tools including 7 step Root Cause Analysis for investigations. • 8d process used and customer complaints.
Senior Manufacturing Quality Specialist
Since August 2014
quality role dealing with raw materials and batch release. Quality role dealing with raw materials and batch release.
Compliance SpecialistNovember 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.
Lead Analytical ChemistJanuary 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 ChemistJanuary 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.
LinkedIn Assessment :
1st class Honours in Chemistry from Mid-kent College in 1992
Area / Region
Kent, England, United Kingdom