Brexit Dublin Licensing Lead
12 month contract
To co-ordinate and plan activities required for Brexit associated with new license changes to support continuity of supply.
• Prepare applications for new Manufacturers / Importation Authorisations, Wholesaler Dealers Authorisations and controlled Drugs / Precursor Chemical Authorisations.
• Implement quality systems required to support licence applications
• Development of the physical location of a new QP Hub, including IT, warehouse storage and TTSs / DRAs.
• Liaison with local regulatory agency as required during the implementation phase
• Coordinate and support licence updates and new licence applications for Trading Partners and LOC's
• Support regulatory inspections where required
• Coordinate activities across different Consumer Healthcare GMS sites and Local Operating Companies (LOCs), holding owners accountable to ensure timely completion of actions
• LOC point of contact for Brexit Quality issues in Consumer Healthcare
• Coordinate and support TTS and QAA updates
• Maintain strong links of communication with all Brexit work streams and key stakeholders
• Provide routine updates on progress, risks and recommendations across GMS and commercial LOCs.
• Liaise with Regulatory and Artwork work streams to ensure interdependencies are identified and managed throughout project lifecycle
• Degree or equivalent level in a scientific discipline
• Fully qualified QP
• Quality Assurance for pharmaceutical production
• Minimum 10 years' experience within the pharmaceutical industry
• Strong knowledge of Quality Systems supporting distribution and importation
• Good knowledge of GMP and GDP and associated licencing requirements
• Regulatory inspection experience and a strong EU regulatory understanding
• Excellent organisational skills, ability to consolidate plans and drive projects forward
• Self-starter, motivated and works on own initiative
• Good communication skills, experience with senior management
• Knowledge and experience of audit processes, preparation and requirements with comprehensive knowledge of regulatory requirements
• The ability to present information in a clear and concise manner in order to support decisions and at audits.
• Ability to plan and organize to meet deadlines and deliver schedule and targets in an environment of change.
• Project management experience and a systematic approach to preparing and maintaining processes to ensure the management and tracking of transformational activities will be required.
• Understanding / ability to demonstrate use of problem solving and continuous improvement techniques
• Attention to detail at all times.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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