Qualified Person

Thermo Fisher Scientific
13 Apr 2016
20 Mar 2017
Contract Type
Job Description Position Summary: The QP will provide support to all appropriate and relevant activities within Fisher Clinical Services, Horsham. The job has three primary functions, QP certifications and declarations, technical contribution to the operations of FCS Horsham and conducting audits. The jobholder will form part of the ‘QP team', supporting the QP certification activities, maintaining an up to date awareness of current legislation and contributing to QP policies. Key Responsibilities: To provide QP certification in compliance with regulatory requirements and if required, specific client technical agreements To provide QP GMP declarations including on site audits if required, in support of importation activities Conducting internal and external audits as required To act as the Quality Lead, the primary contact point for Quality for major clients Provision of GMP training To provide information and training on the EU QP roles and responsibilities to FCS personnel in the UK and outside the UK Provide support to Business Development/ Sales and Project Management at pre-contract stage to assess new contracts To maintain an up to date awareness of the regulatory issues affecting the clinical supplies process keeping relevant FCS colleagues informed where appropriate To provide technical advice and support in the preparation of Technical Agreements. Support client audits with QP input Minimum Requirements/Qualifications: Meets the EU requirements for Qualified Person status Although not essential, the following Skills and Experience would be advantageous: Experience in acting as a QP for IMPs is an advantage Knowledge of pharmaceutical development process desirable