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Summary

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.

Experiences

Current Experience

  • Senior Manufacturing Quality Specialist
    Since August 2014
    Quality role dealing with raw materials and batch release.

Past Experience

  • Compliance Specialist
    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.

  • Diagnostic Specialist
    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.

  • Scientific Officer
    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.

Knowledge

LinkedIn Assessment :
ValidationHPLCISO 13485Manufacturinggas chromatographyPharmaceutical IndustryProcess improvementLC-MSmanagementQuality Assurance (QA)Analytical ChemistryLIMSUVNIR spectroscopyCleaning ValidationCross-functional team leadershipChange ControlQuality SystemsIRGood Laboratory Practice (GLP)GMPLaboratoryContinuous ImprovementBiotechnology

Education

  • 1st class Honours in Chemistry from Mid-kent College in 1992

Area / Region

Kent, England, United Kingdom

Others

Driving License
  • No