Qualified Person (QP)

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p></p><div><div><div><div><div><div><div><div><div><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.<br /><br /><b>This is a Fixed Term Contract (2 years) and is part-time (22.5 hours per week, Monday-Wednesday)</b><br /><br /><b>Position Summary: </b></p></div></div></div></div></div></div></div></div></div><p>The QP will provide support to all appropriate and relevant activities within Fisher BioServices, UK.</p><p>The job has three primary functions, <b>QP certifications and declarations, technical contribution</b> to the operations of FBS UK and conducting audits.</p><p>The jobholder will form part of the ‘Quality team’, supporting the QP certification activities, maintaining an up to date awareness of current legislation and contributing to QP policies.</p><p></p><p><b>Key Responsibilities: </b></p><ul><li><p>To provide QP certification in compliance with regulatory requirements and if required, specific client technical agreements.</p></li><li><p>To perform QP GMP declarations including on site audits if required, in support of importation activities.</p></li><li><p>To perform UK QP Oversight activities.</p></li><li><p>Conducting internal and external audits as required.</p></li><li><p>Provision of GMP training.</p></li><li><p>To provide information and training on the QP roles and responsibilities to FBS personnel.</p></li><li><p>Where needed, support Business Development/Sales and Project Management at pre-contract stage to assess new contracts.</p></li><li><p>To maintain awareness the regulatory issues affecting the clinical supplies process keeping relevant FBS colleagues informed where appropriate.</p></li><li><p>To provide technical advice and support in the preparation of Technical Agreements.</p></li><li><p>Support client and regulatory audits with QP input.</p></li><li><p>May be required to perform off site work where necessary.</p></li><li><p>Travel as required.</p></li></ul><p></p><p><b>Minimum <span>Requirements/Qualifications:</span> </b></p><ul><li><p>Meets the UK requirements for Qualified Person status.</p></li></ul><p></p><p> <b>Hiring Criteria: </b></p><ul><li><p>Experience in acting as a QP for IMPs (experience in biological products preferred).</p></li><li><p>Knowledge of pharmaceutical development process desirable.</p></li></ul><p></p><p></p><p></p><p></p>