Quality Manager - 16 Month Contract

Recruiter
Elevation Recruitment Group
Location
Chesterfield
Salary
Up to £45000 per annum
Posted
29 Sep 2019
Closes
24 Oct 2019
Ref
1278036855
A Site Quality Manager is required, on a fixed term contract, for a leading UK ambient 3PL business providing nationwide contract logistics and supply chain management services to a wide range of companies. With approximately 200 heads and a turnover of a £10million, this is a fantastic opportunity for a Quality Manager to work for a business that is committed to supplying excellent quality products to their customers. The Quality Manager's Duties and Responsibilities will include: - Being named as the primary Responsible Person on the WDA(H) and Controlled Drug licence - Carrying 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.) - Ensuring the Quality and H&S System is implemented and maintained - Being responsible for the generation, revision, approval of procedures and other GDP documents - Being responsible for creation of annual audit programme, performance of RP audits and management of self-inspections - Ensuring that any subcontracted activities which may impact on GDP are approved - Acting as the lead contact for MHRA, client and corporate audits - Being responsible for creation and review and Technical Agreements - CAPA and NCR management. - Being responsible for the management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome. - Reviewing and approving validation protocols and ensure that all systems are validated - Deciding on the final disposition of returned, rejected or falsified products - Coordinating and promptly perform any product recall operations - The management of risk assessment programme and ensure that the mitigation strategies are defined and implemented - Being responsible for change management. - Ensuring that change control processes are in place for documentation, processes and systems - Overseeing sampling and quality assurance release of products - Ensuring that initial and continuous training programmes are implemented and maintained - Reviewing and sign off temperature records and handle all temperature excursions. - Ensuring timely notification to the relevant party for all relevant product temperature excursions. I am keen to speak to individuals with the following: - A professional background and previous experience as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirement of an RP - Knowledge and experience of applying GDP guidelines and H&S - Managerial experience - Experience in examining and re-engineering procedures and developing and implementing new strategies and procedures - Effective time management - Strong attention to detail - Strong interpersonal and communication skills

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