Jobs, fresher vacancy - Quality Manager and Responsible Person • Derbyshire

Company: Great Bear

Derbyshire

Job DescriptionAs Site Quality Manager and Responsible Person you will be responsible for managing the Compliance and H&S department and ensuring the overall GDP compliance of the site.You will have a key responsibility in maintaining and developing all aspects of compliance management and Health & Safety profile of the site. Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate compliance with EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), Human Medicines Regulations 2012 (C17) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.)Working hours: Monday to Friday, 40 hour week.Key Duties of a Quality Manager: Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence for site.Maintain and continually improve the company’s Quality Management System in compliance with current GDP guidelines, applicable certifications and group policies and procedures.Responsible for the generation, revision, approval of procedures and other GDP documentsResponsible for creation of annual self-inspection schedule, performance of RP audits and management of self-inspections.Ensure that any subcontracted activities which may impact on GDP are approvedAct as the lead contact for MHRA, client and corporate auditsResponsible for creation and review of Technical AgreementsCAPA and deviation management. Responsible for management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome.Review and approve validation protocols and ensure that all systems are validatedDecide on the final disposition of returned, rejected or falsified productsCoordinate and promptly perform any product recall operationsManagement of risk assessment programme and ensure that the mitigation strategies are defined and implementedResponsible for change management. Ensure that change control process in place for documentation, processes and systemsOversee sampling and quality assurance release of productsEnsure that initial and continuous training programmes are implemented and maintainedReview and sign off temperature records and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursionsHost Quality Management Review meetings, collate monthly Quality stats and produce compliance reports.Manage team of 3 (Compliance and H&S Manager and 2 Quality Coordinators)