Quality Control Manager, Quality Control, Medical

1 month ago

Great Yarmouth Norfolk, United Kingdom Diomed Developments Ltd. Full time

Gosmore/Kempston/Great Yarmouth - Full Time
An opportunity has arisen for a Group Quality Manager to manage the Quality functions within the Diomed Group. The role will be required to execute QP and possibly RP duties and provide the required direction and support to the Quality Assurance functions responsible for co-ordinating the development and implementation of the Diomed Quality Management Systems (QMS). The role also has responsibility for the Quality Control Laboratory at the Aeropak manufacturing site which performs the required testing on all incoming raw materials, packaging components, bulk products, and increasingly finished goods release testing as it transfers from the head office laboratory. The role will require presence at the Great Yarmouth manufacturing site at least two days/week.
Management of Quality Assurance functions at the Warehouse and Distribution Centre (Kempston), Manufacturing Facility (Great Yarmouth) and Head Office (Gosmore).
Perform the duties of ‘Responsible Person’ as detailed in the ‘Rules and Guidance for Pharmaceutical Distributors’ – MHRA Green Guide.
Liaise with other company QPs within the Group to ensure product quality is maintained at an appropriate level.
Provide expertise on regulatory and QP issues.
Liaise directly with the regulatory authorities on behalf of the company to seek clarification or guidance where necessary.
Manage the Quality Management processes performed across the various Diomed sites, internal/external audits, change controls, deviations, CAPA, validation.
Proactively identify improvements to the QMS through preparation of trending reports for Management Review.
Liaise with 3 rd Party manufacturers to ensure their QMS is working effectively, and regulatory compliance is maintained for the supply of quality product to Diomed.
Act as primary contact and lead regulatory inspections and audits ensuring follow up actions are completed.
Lead and manage teams of QA professionals across 3 sites.
Promote a culture of Quality excellence, driving cultural change within the entire business towards the goal of developing Quality Management System(s) to all areas of the business.
Lead the QC analytical laboratory at the Aeropak manufacturing facility responsible for testing of raw materials, bulk, and finished products. QC also perform incoming inspection and assessment of packaging components delivered to the Aeropak site.
Significant experience working in Quality Management roles within a pharmaceutical environment along with the required experience to effectively perform the expected duties in roles as both QP (& possibly RP).
QP qualifications with a degree or equivalent in a scientific related discipline and or background in a medical health profession.
Ability to strategically develop the Quality function within Diomed Group.
Ability to successful manage multi-disciplinary projects to deliver business benefit and or QMS enhancements.
Experience of Quality Control, ideally in an operational and management capacity.

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