Save JobEmail job Back to Search Job Description Summary Similar JobsUnique opportunity to establish Quality across siteDrive quality standards across the business, and build Quality functionAbout Our ClientMY client is a CRO, specialising in Rare Disease medicines. They are established in the UK and have just received licensing for their Dublin warehouse.Job DescriptionResponsible for ensuring the licence provisions are observed and met.Responsible for ensuring that operations do not compromise patient safety and the quality of supplied medicines.Provide Quality support to the business, championing compliance to GDP, GMP, regulatory and company expectations.Responsible for ensuring that a compliant quality system is established and maintained.Responsible for ensuring GMP and GDP compliance and best practice within all such regulated activities.Responsible for ensuring that adequate records are maintained in relation to GDP, GMP and GDPR activities.Responsible for ensuring that adequate resource and capabilities exist within the quality assurance team and that all personnel are trained and developed in line with the requirements of their role.Responsible for the leadership of direct reports and line management of staff, ensuring a high level of team motivation and morale.The Successful ApplicantProven leadership and management capabilitiesExtensive knowledge of GMP, GDP, especially EU/IE regulatory requirements.Previous experience in secondary packaging and clinical trial supply preferable.Strong understanding of fundamental principles for core Quality Management System processes (e.g. risk assessments, deviations, change control, supplier/customer management)Ability to take a risk-based approach with their day to day activitiesPro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracyExcellent communication skills: verbal and writtenAbility to effectively communicate and navigate various stakeholders in management and non-management positions to drive action and project completionIT literate: Microsoft Outlook, Word, Excel is essentialHighly self-motivated with strong inter-personal skillWhat's on OfferThis is a unique opportunity to establish an entire Quality system and function within a new business.ContactAlex HenmanQuote job refJN-062023-6087080Phone number+44 172 773 0105Job summaryJob functionLife SciencesSubsectorQualitySectorPropertyLocationInternationalContract typePermanentConsultant nameAlex HenmanConsultant phone+44 172 773 0105Job referenceJN-062023-6087080
