Quality Manager and Responsible Person

Great Bear; Hasland; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading logistics company in the United Kingdom is seeking a Site Quality Manager to oversee the compliance and health & safety department. The successful candidate will manage the Quality Management System in line with EU guidelines and legislation. Responsibilities include acting as the primary Responsible Person, conducting internal audits, and managing a team of compliance staff. This role offers a full-time position with standard working hours from Monday to Friday.

Qualifications

• Experience with EU guidelines on Good Distribution Practice.
• Proven track record in managing compliance and health & safety.
• Ability to manage and train a team.

Responsibilities

• Manage the Compliance and H&S department.
• Act as the primary Responsible Person for the site.
• Maintain and improve Quality Management System.

Skills

Compliance management

Health & Safety knowledge

Education

Relevant qualifications in Quality Management

Tools

Quality Management Systems

Job description

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)