Experience

Fusion Consulting Group

• United Kingdom
• Business Consulting and Services
• 1 - 100 Employee

• Validation Manager

  • Dec 2021 - Present

  SAP Validation Management. SAP Validation Management.



CPD QA Ltd

• UK/Europe, Worlwide

• Contract Validation Consultant

  • Oct 2014 - Present

  Serialisation;- Level 1 through to Level 4 systems, implementation and validation of serialisation and aggregation systems.(GAMP 5) Specialist Quality Management Provision. Track and Trace systems validation CSV Quality by Design. Anti Counterfeiting (Pharmaceutical) ;-Specialist in Secure Track and Trace Systems (S-TTS) validation and qualification. Validation of specialist Pharmaceutical equipment (GMP), IQ,OQ and PQ Document creation, review, issue and control of URS , FS, Traceability Matrix, Design Qualification Reviews, FAT, SAT, IQ, OQ and PQ documents as required. Validation Reports. Development of Quality Management Systems. Working in contract with Performance Pharma Tech Ltd.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global eCompliance and Quality Authority

  • Feb 2020 - Oct 2021



CPD QA LIMITED

• Northamptonshire

• Serialisation Consultant (Validation /Project Management)

  • Oct 2014 - Feb 2020

  Implementing Pharmaceutical Serialisation systems in Pharmaceutical settings. New systems identification of requirement, preparation of User Requirement Specifications, Functional Specifications, Design Quality Reviews, Tracebility Matrices, Validation Master Plan , Risk Assesments, Validation Determination Statements, IQ/OQ/PQ and Validation reports. Execution of FAT/SAT IQ/OQ/PQ . Experience with TraceLink , OPTEL, Marchesini, Laetus, HERMA, CAM and many other OEM companies. Implementing Pharmaceutical Serialisation systems in Pharmaceutical settings. New systems identification of requirement, preparation of User Requirement Specifications, Functional Specifications, Design Quality Reviews, Tracebility Matrices, Validation Master Plan , Risk Assesments, Validation Determination Statements, IQ/OQ/PQ and Validation reports. Execution of FAT/SAT IQ/OQ/PQ . Experience with TraceLink , OPTEL, Marchesini, Laetus, HERMA, CAM and many other OEM companies.



Laetus GmbH

• Germany
• Machinery Manufacturing
• 1 - 100 Employee

• Validation Consultant

  • 2014 - 2016



ProductLife Group

• France
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality Improvement Manager-Pharmacovigilance

  • May 2014 - Oct 2014

  PharmacoVigilance ProductLife offers a complete range of pharmacovigilance and medical monitoring services, with a unique ability to tailor our services directly to your needs. We have global capabilities and work within all applicable regulatory and international requirements. Clinical Drug Safety Services: Full Serious Adverse Event case management (SAE processing, SUSAR submissions) Developmental Safety Update Reports (DSURs) Medical Monitoring EudraVigilance registration and maintenance Post Marketing Drug Safety Services: Provision of Qualified Person for EudraVigilance (QPPV) Pharmacovigilance systems management: - Literature review - Pharmacovigilance System Master File - Management and reporting of adverse reactions (Individual Case Safety Reports) Periodic Safety Update Reports & Risk Management Plans eXtended EudraVigilance Medicinal Product Dictionary Our team of specialists can help you in outsourcing parts or all of your pharmacovigilance tasks. We can provide small to mid-sized pharmaceutical companies the benefits of a fully-staffed pharmacovigilance unit.



Echo Packaging Ltd

• Corby Northants

• Quality and Compliance Manager

  • Jan 2014 - May 2014

  UKs largest producer of recycled plastic bags. Implementing Quality Systems and safe systems of work, Staff training, Customer liaison. Moving towards ISO9001, ISO14001 certification. UKs largest producer of recycled plastic bags. Implementing Quality Systems and safe systems of work, Staff training, Customer liaison. Moving towards ISO9001, ISO14001 certification.



Freelance, Quality and business development

• Kettering

• Business Consultant

  • Nov 2010 - Jan 2014

  Helping organisations with Quality System implementation and strategic business development. Helping organisations with Quality System implementation and strategic business development.



Eden Renewable Energy Ltd

• Kettering

• Director

  • Aug 2009 - Nov 2010



Nutherm Ltd

• Kettering

• Business Development Manager

  • Oct 2007 - Aug 2009

  Renewable Energy, New business development Renewable Energy, New business development



Independent Clinical QA Consultant

• Home based

• Clinical QA Consultant

  • Nov 2005 - Oct 2007

  Working with 3 Pharmaceutical companies. Auditing studies, investigator sites and study documents. Working with 3 Pharmaceutical companies. Auditing studies, investigator sites and study documents.



Parexel International

• Director of Quality Management

  • Mar 2004 - Nov 2005

• Clinical Quality Manager

  • Mar 2003 - Mar 2004

  Implement Quality Systems in line with GCP. Internal study audits, host regulatory and client/sponsor audits, staff training. Part of a team undertaking International Quality initiatives.



Napp Pharmaceuticals Holdings Limited

• Clinical QA officer

  • 2000 - 2003

  Audit Clinical studies (Phase I to III) at Investigator sites in the UK and across Europe and the US , Part of the International Quality Assurance team. Audit Clinical studies (Phase I to III) at Investigator sites in the UK and across Europe and the US , Part of the International Quality Assurance team.



AstraZeneca Pharmaceuticals Ltd

• Great Oakley Corby

• Quality Compliance Leader

  • Aug 1996 - Mar 2000



AstraZeneca

• Great Oakley Corby

• Validation and GMP Technician

  • Mar 1996 - Aug 1996



AstraZeneca Pharmaceuticlas Ltd

• Graet Oakley Corby

• Quality Assurance Technician

  • Feb 1995 - Mar 1996



Royal Navy

• United Kingdom
• Armed Forces
• 700 & Above Employee

• Leading Seaman Sonar Submarines

  • Jan 1987 - Jan 1992

  1987-1989 Able Seaman Sonar (ABSSM) Submarine Service, SSN Hunter Killer Submarines. HMSM Sovereign. 1989-1992 Leading Seaman, Submarine Movements Advisory Authority.(SMAA) HMS Warrior, Northwood Middlesex. Internal Security Team (Marksman) Weapons Handling and Safety Competency Certified- July 2017 1987-1989 Able Seaman Sonar (ABSSM) Submarine Service, SSN Hunter Killer Submarines. HMSM Sovereign. 1989-1992 Leading Seaman, Submarine Movements Advisory Authority.(SMAA) HMS Warrior, Northwood Middlesex. Internal Security Team (Marksman) Weapons Handling and Safety Competency Certified- July 2017