To establish, develop and monitor the quality systems applicable to the pharmacy service with a particular focus on those relatin.....
To establish, develop and monitor the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing, Wholesale Dealing, Dispensary and other registered activity To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc. To undertake and support the preparation of SOP To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment To lead and co-ordinate internal quality audits (Production Unit and Stores and distribution) and external audits as required To ensure that appropriate validations are carried out including production and QC processes and that the resultant reports are written and distributed To approve written, or amended master worksheets, which relate to or might impinge upon licensable activities To set up technical agreements for outsourced service e.g. domestic services in compliance with GMP and QAAPS standards Responsible for organising regular QA/Production, QA/WDA and QA/Dispensary meetings to maintain Quality Assurance within the pharmacy and to monitor progress against internal and external inspections To be responsible for the internal procedures and policies relating to the release and rejection of materials by the Releasing Officers As a releasing officer, responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records. To be responsible for the approval or rejection of purchased unlicensed pharmaceuticals and for writing assessments for approval of suppliers. To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with the Production Manager if results are outside of recommended guidelines To embed quality risk management principles in all processes and documentation. This includes performing risk assessment in line with regulatory standards e.g. ICH, PIC/S, GMP To write, assess and evaluate tender specifications for services and equipment. To monitor outsourced services and escalate any deficiencies Ensure that key GMP records such as the site master file, validation master plan, control strategies and the quality manual is kept up to date and meets the needs of service users, in conjunction with regulatory, licensing and accreditation bodies. To support and where indicated lead investigations into deviations in quality processes To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC Ensure appropriate escalation of all risks and outstanding corrective and preventative actions Coordinate the investigation of relevant complaints in accordance with the complaints policy and procedure, in conjunction with service. Promote the provision of a customer centred approach in the provision of pharmacy services Liaise with service users through forums and surveys to establish views and opinions that will help to improve service standards. Provide monthly performance reports to the Pharmacy Quality Management Committee and Management Board Maintain relevant records, ensuring accurate data input into all computerised systems. To validate computerised systems (licensed activity only) to meet regulatory compliance Maintain an archive of all controlled documents in accordance with the data integrity requirements of regulatory, licensing and accreditation bodies, and in compliance with corporate policy and national legislation and guidance. Collect, interpret and present quality management data and statistics for use in monitoring the quality management system. Ensure robust systems are in place to develop staff, to ensure they can carry out their work safely and efficiently, working to the high standards demanded of the service, and providing evidence of competence assessment To manage the work of the Senior Pharmacy QA officer , ensuring that task are delegated appropriately Training To prepare and present tutorials and training sessions, both within the department, and externally as required To be responsible for the competency checks of Releasing officers and production staff and assessment prior to signing off training records To ensure that the Continuing Professional Development needs of the releasing officers are met To act as a mentor for Principal Department Leads across Pharmacy Monitor the review of training competences across the relevant parts of the pharmacy service, promptly reporting deficiencies to service managers as appropriate. Educate and train staff in quality principles and practice. Ensure that staff are adequately trained to understand and use the quality management system as relevant to their roles, and that training and competences are suitably documented and reviewed To assist in the design and provision of necessary commissioning of new production facilities and equipment To offer QA expertise and resources to other departments as required by the Trust To be responsible for the development and validation of new processes and methods in Quality Assurance and in the Production facilities. To maintain procedures and implement changes resulting from the updating of GMP and other regulatory standards and guidance documents To ensure the implementation of national and regional policies within Pharmacy To be named as the responsible person for Quality Control (Quality Controller) on regulatory MHRA manufacturers licenses as appropriate To be the Quality Control representative for Wholesale Dealing Activities. To represent Pharmacy Technical Service at CRH NHS Foundation Trust at internal development/management meetings, external regional meetings (East Midlands Technical Services Meetings) and nationally (National QA Symposium). Follow up on external inspections and verify the completion of corrective action as required by the inspectors reports in collaboration with service managers To contribute to the implementation of Quality Governance within the pharmacy service. To provide QA support into the operation of Clinical Trials in the department.
