DERMAL QUALITY MANAGER
Dermal Laboratories –Gosmore, HitchinKempston, Bedford
Full Time
Dermal Laboratories (part of the Diomed Group) has an enviable portfolio of mainly topically applied healthcare products, several of which are brand leaders.
Reporting to the Group Quality Manager, you will be responsible for assisting with the design and implementation of the Diomed Group’s cross-departmental and integrated Quality Management System, particularly in relation to functions undertaken at the Kempston and Gosmore sites, including purchasing supply, warehousing distribution, product design development, clinical research, pharmacovigilance, regulatory affairs and sales & marketing
The responsibilities will be varied, but will include through leadership and example, helping to foster and implement the Diomed QMS and Quality Policy across the organisation and with relevant third party service providers. Providing expertise to assist the specified functions to design and implement cross-departmental and integrated quality management solutions, in accordance with current regulatory requirements for medicines, medical devices and cosmetics. Assisting in the planning and execution of internal/external audits to ensure conformance of the specified functions with written QMS Policies, SOPs, Work Instructions,etc, and with regulatory requirements. Assisting specified functions to identify, monitor and report to senior management appropriate metrics on the performance of the QMS. Assisting the relevant teams in the investigation and remedy of product quality issues, including co-ordination with product risk management and CAPA processes. Providing QA oversight and authorisation of controlled documents originating from the specified functions as part of their QMS requirements.
The successful applicant must have as a minimum a B.Sc. in a relevant subject and suitable qualification/training in QA in the pharmaceutical and/or medical device industry, together with expertise in a broad range of quality management systems such as ISO 13485, Good Clinical Practice, Good Manufacturing Practiceand Good Pharmacovigilance Practice, preferably relevant to purchasing supply, warehousing distribution, product design development, regulatory affairs and sales & marketing - in accordance with the legal and regulatory requirements for medicines, medical devices and cosmetics. The role demands excellent problem solving skills with a demonstrable ability to identify practical and effective solutions.Very good inter-personal skills and diplomacy, with the ability to attain
co-operation at all levels within the organisation and externally, and excellent communication skills, both verbally and in writing, are also required.
If you are tempted by this opportunity, to find out more or apply, please contact Catherine Beattie, telephone 01462 458866 or email your CV and a covering letter to .