**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Position Summary:** Join our ambitious team at Thermo Fisher Scientific Inc. and take on a pivotal role within our world-class manufacturing department! As a Qualified Person, you will be instrumental in ensuring the flawless execution of our operations at Patheon UK, driving outstanding quality and compliance. **Responsibilities:** + Complete Qualified Person (QP) responsibilities, duties, batch certification, and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU, and Eudralex Volume 4, Annex 16. Ensure adherence to relevant cGMPs for products released to the US market. + Ensure that products are manufactured in strict accordance with GMP, site procedures, and applicable regulatory requirements. + Stay in sync with international regulatory guidance, corporate, and client requirements. Ensure all site work aligns with these standards. + Continuously upgrade technical and professional competence, ensuring complete understanding of any new product or process before conducting QP batch certification and disposition. + Conduct regular audits, self-inspections, and spot checks. + Support investigations, root cause analysis, and approve Major/Critical deviations, complaints, and change proposals with process/product impact. + Support the QMR process and the implementation of Operational Excellence by encouraging peers and collaborators to identify and implement improvements. + Act as change agents, driving balanced improvements to work processes. + Proactively ensure continuous improvement of the QMS, maintaining it in an inspection-ready state. + Drive and react to system trending (e.g., deviations, complaints, and environmental management) ensuring ongoing quality performance and improvements. + Establish and maintain effective communication with clients to align internal and external expectations. + Provide backup for other QPs on site. **EHS:** + Implement emergency procedures and safe systems of work. + Ensure compliance with environment, health, and safety rules at all times. + Promptly report and investigate all accidents, near misses, and breaches of rules. **Minimum Requirements/Qualifications:** + Minimum Degree in Chemistry, Pharmacy, or Microbiology. + Minimum 3 years of experience completing 'Qualified Person' responsibilities as outlined in 2001/83/EC and 2001/82/EC (as amended). + Substantial experience in a pharmaceutical quality function within a sterile manufacturing site. + Up-to-date knowledge of GMP guidelines (UK "Orange Guide", EU "Eudralex Volume 4", U.S. "CFRs" and other relevant regulations). + Excellent scientific and technical knowledge. + Not on the "FDA DEBARMENT LIST". **Key Skills:** + Capable of working to deadlines and prioritizing multiple tasks. + Excellent written and verbal communication skills. + Flexibility to meet changing business needs and priorities. + Pragmatic, well-organized with a logical and methodical approach. + Leadership experience with the strength of character to guide cross-functional teams. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.