Quality Systems Manager Pharmacy Technician An exciting opportunity has arisen to join the North Bristol NHS Trust (NBT) Pharmacy Quality Assurance Team. The role of the Quality Systems Manager will be to effectively lead implementation and ongoing management of the pharmacy electronic Quality Management System ensuring it meets the required needs across the department and all regulatory compliance.
The Pharmacy department at NBT is a forward thinking, dynamic and innovative team with a strong clinical and patient focus, all underpinned by good governance.
To learn more about Pharmacy at NBT, click here to watch our video.
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Main duties of the job Provide leadership and operational management for the development of robust processes for the management of all Pharmacy SOPs ensuring they meet requirements of relevant legislation.
Be the main point of contact within the department for implementation and ongoing day-to-day management and maintenance of the IQM system. As a subject matter expert in pharmacy, they are expected to show in-depth knowledge in the systems reporting capabilities, with a detailed understanding of application within pharmacy.
Under the direction of the Quality Assurance manager and Associate Director of Pharmacy - Medicines Governance & Safety, support key senior managers, pharmacists, section leads and other users with audit programmes across the Pharmacy Department, including presenting, when necessary, the data to a range of audiences.
Lead on the specialist training, and coaching users, in the IQM system, with analysis and interpretation of the information and how to use it to guide their decision making, advising on issues of data standards and quality, as well as regulatory requirements.
Co-ordinate an ongoing training programme and assessment for the correct use of the IQM system and related SOPs.
Deputise for the Quality Assurance Manager in managing the introduction / approval of new medicines and the safe and effective releasing of unlicensed / off label medicines.
About us North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialties. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Job responsibilities GPhC accredited Pharmacy Technician Apprenticeship at Level 3 or above, or equivalent. Registered Pharmacy Technician with the General Pharmaceutical Council. Experience in the development and writing of Standard Operating Procedures (SOPs). Highly numerate with experience in report design and production. Experience and understanding of managing Quality Management Systems. Experience of managing change or project management. Knowledge in and implementation of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP). Knowledge and understanding of Wholesale Distribution Authorisation (WDA) for Medicinal Products. Knowledge and understanding of Medicines and Healthcare Products Regulatory Agency (MHRA) and licensing guidelines and standards. Excellent interpersonal skills and the ability to liaise effectively with staff at all levels within the hospital and with patients/ carers; the ability to adapt their communication style to effectively relay, often complex or sensitive, information to people with varying levels of medical/pharmaceutical knowledge. Ability to communicate in a compassionate manner Ability to work as part of a team and also use own initiative as part of the defined role. Ability to work without direct supervision, innovate and use initiative. Ability to manage own workload and prioritise work to meet deadlines. Ability to motivate others and act as a role model. An understanding of validation in quality assurance. Ability to work beyond the scope of initial pathways, making other observations that may be beneficial to users of the IQM system. Advanced skills in MS Office software including presentation, word processing, spreadsheet and database functionality as well as an understanding of the data held in the IQM system, their interrelationships and their appropriateness and fitness for use Provide general IQM system support to the department, addressing issues with the system directly where possible, and liaising with the system provider if not. Carry out the IQM system portion of the new staff induction process, including organising access to the system and providing system training. Be an expert user on the recording and monitoring tools available to effectively report IQM and QMS performance metrics. Design and develop systems to support any CIP improvement plans from the effective use of the IQM system. Play an active role in the monitoring of performance within the department. Collate information in response to Freedom of Information requests received by the Trust that relate to pharmacy/drug data through the IQM system. Ensure any developments to the system are supported by the necessary business cases. Ensure all regular and routine reports are submitted complete and validated, by agreed deadlines. Maintain up-to-date procedures detailing the reports provided regularly to the Pharmacy Quality Management Meetings and Pharmacy Governance Board. Provide leadership to ensure that a professional, safe, and efficient service is provided to all users of this service. Act as a named IQM Super-User who is responsible for the efficient operation of the system. Ensure change control processes are implemented, monitored and reported with Corrective And Preventive Actions (CAPA) embedded into the IQM system. Assist the pharmacy section leads with audit and project work and the development and implementation of procedures, ensuring a robust integrated quality systems across the Pharmacy Department are maintained. Dispense prescriptions for inpatients, outpatients, and discharge medication this may involve the assessment of Patients Own Medicines where appropriate. Dispensing includes clinical trial and named patient medicines, Controlled Drugs, cytotoxic products, extemporaneous preparation, when necessary, private prescriptions and assembly of compliance aids; robust dispensing skills including accurate weighting, measuring, counting a preparation of medication is required; appropriate specialist equipment and PPE may be required at times. Answer routine queries from ward staff and from patients. Assist in the supervision and training of ATOs, SATOs and Student Pharmacy Technicians and the induction of new members of staff. Participate in the identification and production of new departmental procedures where appropriate. Check dispensing for inpatients, outpatients, and discharge medication as per department checking procedure. Undertakes Continuing Professional Development to maintain clinical skills in relation to training and other professional commitments. Deputise for the Lead Pharmacy Technician Clinical Informatics in the management of drug files, cost centres, supplier records and other data elements on the Pharmacy Stock Control System. Participation in the weekend, late rota, and bank holiday rota, acting as Lead Pharmacy Technician for the dispensary weekend service when appropriate. Any other duties, which may be required by the Director of Pharmacy for the benefit of the service.
Person Specification Education/Training/Qualifications A GPhC accredited Pharmacy Technician Apprenticeship to Level 3 or above, or a recognised equivalent qualification
Registration as a practising Pharmacy Technician with the General Pharmaceutical Council
Recognised current Accredited Checking Technician qualification (or significant progress towards)
Evidence of Continuing Professional Development
Leadership and Management qualification - level 3
Work Experience Understanding of the management of Quality Management Systems (QMS) in a pharmacy setting
Use of data analysis tools to present information from pharmacy/other clinical systems
Experience of training staff
Experience of writing and developing Standard Operating Procedures
Experience of project management
Experience of risk management
Knowledge/Skills/Abilities Excellent IT competencies with a clear understanding of the complex issues involved in implementation of a new Quality IT System
Excellent communication, interpersonal and organisational skills
Standard I.T. competencies in Word, PowerPoint and Excel or equivalent programs
Ability to extract and interpret data to affect decision making
Knowledge of quality management system and QA applications, such as IQM
Personal Qualities/Special Circumstances Self-motivated individual with an organised and logical approach to work
Able to deal and communicate professionally with all levels of staff within own organisation, other NHS organisations, Industry and Pharma partners as well as patients
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Asso.Director of Pharmacy - Medicines Gov & Safety
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