At a Glance
- Tasks: Lead compliance and health & safety efforts while ensuring top-notch quality management.
- Company: Join Great Bear, part of the thriving Culina Group, known for its empowering culture.
- Benefits: Enjoy a supportive environment where you're valued and inspired to grow.
- Other info: Be part of a winning culture with excellent career advancement opportunities.
- Why this job: Make a real impact on compliance and quality in a dynamic distribution setting.
- Qualifications: Experience in quality management and compliance is essential.
The predicted salary is between 36000 - 44000 £ per year.
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 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.
Quality Manager in Jedburgh employer: Great Bear
At Great Bear, part of the Culina Group, we pride ourselves on fostering a dynamic and inclusive work environment at our Deeside site, where every employee is valued and empowered to drive continuous improvement. With a strong focus on personal development and a culture that celebrates success, we offer comprehensive learning programmes and a range of benefits, ensuring that you can thrive both professionally and personally in your role as a Continuous Improvement Engineer.
