Experience

Instead Consulting

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director

  • Oct 2018 - Present

  I founded Instead in 2018 because I care deeply about patient safety and want to help clients to make safer medicines. I have a passion to help people develop and deliver practical and pragmatic quality solutions and compliance programmes. My desire is always to delight clients and work in partnership to enable them to enhance quality, reduce risk and improve regulatory compliance.I love designing systems and processes that deliver strong levels of compliance and drive performance.I love sharing knowledge and insights that help individuals and teams to grow and become more confident with GxP issues.I love meeting new people, reviewing systems and auditing sites.I love to always keep learning.



Sheffield Hallam University

• United Kingdom
• Higher Education
• 700 & Above Employee

• Pharmaceutical and Biosciences Sector Forum Member

  • Feb 2017 - Apr 2019



Research Quality Association (RQA)

• United Kingdom
• Industry Associations
• 1 - 100 Employee

• GMP Committee Member

  • Sep 2016 - Apr 2019



Quality Context Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Owner and Founding Director

  • Jul 2009 - Oct 2018

  I was the owner and founding Director of this business for almost ten years. I was accountable for driving the company towards achievement through the implementation of a robust business plan, with customer focus, compliance and quality at the forefront of the business practices, planning cost-effective operations and market development activities, offering expert quality solutions and contract analytical testing to pharmaceutical and healthcare businesses. I was accountable for providing oversight and analysis of financial performance, investment and other business ventures, forging key relationships with competitors and supporters alike to grow the company into a reputable and respected organisation over several demanding and diverse projects. I also had responsibilities for delivery of consultancy projects, world-wide, to provide clients with sound, strategic advice to optimise process and policy and uncover potential. Major responsibilities included: - QP responsibilities as outlined in Directives 2001/83/EC and 2001/82/EC. This included being named as a QP on the Quality Context MIA and MIA IMP from August 2016 – October 2018 and various contract QP roles for both large and small pharmaceutical and healthcare businesses. - Development, implementation and management of simple and compliant Quality Management Systems, policies and procedures and acting as the host of several MHRA and ISO inspections.- Delivery of specialist compliance consultancy, providing guidance on technical and regulatory requirements, with a proven track record of delivering strong performance and profitability improvements while maintaining company values. - Installation, maintenance and management of a fully functional, regulated, onsite GMP laboratory offering analytical testing.- Troubleshooting on a wide range of technical problems.- Conduct of GMP, GDP and ISO audits and gap analyses. - Writing of Standard Operating Procedures (SOPs).- GMP, IMP and quality training.



The Sheffield UTC Academy Trust

• United Kingdom
• Primary and Secondary Education
• 1 - 100 Employee

• Science Link Governor

  • Oct 2016 - Jun 2018



Britannia Pharmaceuticals Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Manager and Qualified Person

  • Dec 2007 - Dec 2009

  Responsible for the company’s GMP Quality System to ensure that their medicinal products were manufactured in compliance with current pharmaceutical legislation and the respective Marketing Authorisations. Centrally involved in fostering quality best practice within the company. Hosted GMP inspections and played a key role in GCP inspections with respect to IMP management. Worked closely with procurement colleagues to implement manufacturing improvements, import medicinal products from third countries and plan and conduct batch certifications and release. Provided technical support to regulatory colleagues with respect to licence variations for commercial projects.

• Pharmaceutical Development Manager/QA Manager

  • Dec 2005 - Dec 2007

  Responsible for the pharmaceutical development, from pilot to commercial scale, for all nasal (powder and liquid) products using contract development companies and third party manufacturers; this included coordination and manufacture of all clinical trial supplies. Accountable for the implementation and maintenance of quality systems within the department and conducted internal and external audits.

• Process Development Manager

  • Aug 2004 - Dec 2005



Wyeth Consumer Healthcare

• Senior Formulation Development Scientist

  • Jun 2003 - Aug 2004

  Leader of various multidisciplinary teams and lead formulator for a number of strategically important and complex global projects including the development of powder, tablet, liquid, soft-chew and pastille formulations

• Formulation Development Scientist

  • Jan 2001 - Jun 2003



GALPHARM INTERNATIONAL LIMITED

• United Kingdom
• Pharmaceutical Manufacturing

• Formulation Development Scientist

  • Jul 1998 - Sep 1999