Quality Manager

As a Quality Manager 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) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.) - Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence - Maintain and continually improve the company’s Quality Management System in compliance with current MHRA GDP guidelines, applicable certifications and group policies and procedures. - Responsible for the generation, revision, approval of procedures and other GDP documents - Responsible for creation of annual audit programme, performance of RP audits and management of self-inspections. - Ensure that any subcontracted activities which may impact on GDP are approved - Act as the lead contact for MHRA, client and corporate audits - Responsible for creation and review of Technical Agreements - CAPA and NCR 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 validated - Decide on the final disposition of returned, rejected or falsified products - Coordinate and promptly perform any product recall operations - Management of risk assessment programme and ensure that the mitigation strategies are defined and implemented - Responsible for change management. Ensure that change control process in place for documentation, processes and systems - Oversee sampling and quality assurance release of products - Ensure that initial and continuous training programmes are implemented and maintained - Review and sign off temperature records and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursions - Host Quality Management Review meetings, collate monthly Quality stats and produce compliance reports. - Manage team of 3 (Compliance and H&S Manager and 2 QA Specialists) - You will ideally have a professional background and previous experience (minimum 3-5 years) as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirement of an RP - Quality Manager experience - Knowledge and experience of applying GDP guidelines and H&S - Experience in examining and reengineering procedures and developing and implementing new strategies and procedures - Effective time management - Strong attention to detail - Strong interpersonal and communication skills - Confidence and assertiveness - Excellent IT skills (including Microsoft Office packages) - Dynamic and self-motivated, keen to achieve excellence within the business