Quality Manager and Responsible Person

Great Bear (Part of the Culina Group) provides distribution services to FMCG clients. Customer centric service focus is delivered through a site-level empowered culture.

At Culina we have a winning culture, we believe that our culture is one of the reasons our company continues to thrive… A place where you're valued, challenged, and inspired!

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)

• You will ideally have a professional background and previous experience as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirements of an RP
• Hold Cogent Gold Standard Training Certification for Responsible Persons
• 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
• Dynamic and self-motivated, keen to achieve excellence within the business

As part of our drive to make Great Beara great place to work. We are proud to be an inclusive and diverse organisation where we are committed to employee development and recognising success for hard working performers.

Our dedicated learning and development programmes are open to every employee to give you the opportunity to shape your own future within logistics and continue to work in an environment where team culture thrives.

Our People are the driving force behind our success, which is why we offer a wide range of benefits which include:

• Annual Leave – Competitive holiday entitlement of 25 days…