As 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 documents
• Responsible 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 approved
• Act as the lead contact for MHRA, client and corporate audits
• Responsible for creation and review of Technical Agreements
• CAPA 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 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 Quality Coordinators)