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Keywords
Description
Promoting quality achievement and performance improvement throughout the organisation;Liaise with other managers and staff throughout the organisation to ensure that the EQ system is functioning properly. Where appropriate, advise on changes and their implementation and provides training, tools and techniques to enable others to achieve qualityMonitor and advise on the performance of the quality management system and produces data and report on performance, measuring against set indicatorsSetting EQ compliance objectives and ensuring that targets are achievedAssessing the output and service delivery of the company and its suppliers, and comparing with customer requirementsWorking with purchasing staff to establish quality requirements from external suppliersEnsuring compliance with national and international standards and legislationAgreeing standards and establishing clearly defined quality methods for staff to applyDefining quality procedures in conjunction with operating staffSetting up and maintaining controls and documentation proceduresIdentifying relevant quality-related training needs and delivering trainingCollating and analysing performance data and charts against defined parametersEnsuring procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessaryWriting technical and management systems reportsBringing together staff of different disciplines and driving the group to plan, formulate and agree comprehensive quality proceduresPersuading reluctant staff to change their way of working to incorporate quality methodsLiaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specificationsEstablishing standards of service for customers or clientsPreparing clear explanatory documents such as customers' chartersMonitoring performance by gathering relevant data and producing statistical reportsResponsible for ensuring adherence to all companies, external and appropriate regulatory requirementsSupport personnel in relevant continuous improvement activities (Six Sigma)Management of Key quality systems elements relating to direct production support such as the non-conformance system, incident reporting system and customer complaint analysisDriving key changes and improvements in the Engineering Quality and control systemsLiaise with key external customersPrepare and Maintain documentation in compliance with appropriate regulatory requirements
GMP oversight and compliance of Calibration and Engineering Quality
A primary degree in a Quality/Science/Engineering discipline.A minimum of 5 years work experience in a GxP Pharmaceutical, ISO 9001 or ISO 13485 accredited environment.A working knowledge of medicine agency requirements and managing auditsExcellent communication and organisational skills with experience in the preparation of Technical DocumentationAdvanced influential negotiating skills - experience of operating at senior client levelAn ability to develop relationships quicklyExperience of working with a quality management system with a high degree of procedural, technical and HSE compliance
Knowledge of Statistical Process Control and Six Sigma methodologies would be desirable (Greenbelt Certification would be advantageous).
‐ Onsite