Pharmacy Quality Systems Manager

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Job Overview 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, watch our video. Main Duties
Interpret user requirement system specifications from key stakeholders to build the IQM system and conduct adequate validation. Communicate in a tactful and persuasive manner to colleagues who may be angry or frustrated due to differing priorities across the department. 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. Support key senior managers, pharmacists, section leads and other users with audit programmes across the Pharmacy Department, including presenting the data to a range of audiences. Lead on the specialist training, coaching users in the IQM system, analysing and interpreting the information and guiding decision making. Advise on data standards and quality, as well as regulatory requirements.
Quality Assurance Duties
Provide general IQM system support to the department, addressing issues 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. Vet requests for changes to the IQM system and determine whether they are feasible and appropriate, and work with the requestor to manage their expectations if necessary. Develop all contingency plans relating to IQM system management. Manage and lead on any upgrades and updates to the IQM System. Manage own workload and prioritise requests for system changes and reports, and balance these demands against the requirements for regular reporting, and other clinical/technical duties. Raise any issues or concerns with workload immediately with the Quality Assurance Manager or Associate Director of Pharmacy – Medicines Governance & Safety if deadlines cannot be met. Support the day‑to‑day management system for monitoring the temperature the storage of medicines across the Pharmacy Department and support, when necessary, any changes to this system. Act as cover for QA release activities across the department, reporting any deficiencies to the Associate Director of Pharmacy – Medicines Governance & Safety.
Management Duties
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 responsible for the efficient operation of the system. Ensure ‘change control’ processes are implemented, monitored and reported with 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. Produce a comprehensive workplan to ensure that all local policies and procedures are implemented and reviewed in accordance with corporate, clinical, and legislative guidance, liaising with the Clinical Policies and Guidelines team where any pharmacy SOPs or policies affect the whole Trust. Contribute to the department’s QA team annual strategy and support the recruitment of any new team members. If a registered Pharmacy Technician and operationally required, act as Lead Pharmacy Technician in the dispensary as part of dispensary/weekend commitment, ensuring that workload is prioritised and processed appropriately by supervising staff within the dispensary.
Dispensary Duties
Dispense prescriptions for inpatients, outpatients, and discharge medication – this may involve the assessment of Patients’ Own Medicines where appropriate. All administrative procedures associated with the above (charging/exemption and completing necessary records) Issue Controlled Drugs to wards and theatres. Record issues, returns, and receipts to maintain an accurate stock balance. Record all transactions using the Pharmacy Computer System to ensure stock levels are accurate and up to date. Prepare orders for wards, other departments and non‑NBT entities. Answer routine queries from ward staff and from patients. Participate in the identification and production of new departmental procedures where appropriate.
Dispensary Duties (Registered Pharmacy Technician only)
Assist in the supervision and training of ATOs, SATOs and Student Pharmacy Technicians and the induction of new members of staff. Check dispensing for inpatients, outpatients, and discharge medication as per department checking procedure. Issue dispensed medicines to patients/carers and provide appropriate advice.
Other Duties
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 as either a dispenser or accredited checking technician, 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. Participates in rotational schemes to provide services on weekend, late night and Bank Holidays.
Education / Training / Qualifications
A GPhC accredited Pharmacy Technician Apprenticeship to Level 3 NVQ and BTEC National Certificate in Pharmacy Services, or an equivalent scientific or healthcare discipline related to the job role, or a recognised equivalent qualification at degree level IT competencies equivalent to ELITE/ECDL, including experience of using specific Quality Management Systems and a good working knowledge of standard PC software such as Microsoft Office packages Evidence of Continuing Professional Development Leadership and Management qualification level 3 Project management qualification Recognised current Accredited Checking Technician qualification or completion of an accredited final accuracy checking programme (or significant progress towards)
Work Experience
Understanding of the management of Quality Management Systems (QMS) in a pharmacy setting Experience of project management 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 (with evidence) of managing major operational change within an organisation Experience of risk management Highly numerate with experience in report design and production. Experience of 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.
Knowledge / Skills / Abilities
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 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. An understanding of validation in quality assurance. 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.
Personal Qualities / Special Circumstances
Self‑motivated individual with an organised and logical approach to work Excellent time management while working under pressure Ability to motivate others and act as a role model. Ability to work beyond the scope of initial pathways, making other observations that may be beneficial to users of the IQM system.
Person Specification Education / Training / Qualifications Essential criteria
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
Desirable criteria
Leadership and Management qualification - level 3
Work Experience Essential criteria
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
Desirable criteria
Experience of project management Experience of risk management
Knowledge / Skills / Abilities Essential criteria
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
Desirable criteria
Knowledge of quality management system and QA applications, such as IQM
Personal Qualities / Special Circumstances Essential criteria
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
EEO statement 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 under‑represented groups. Application logistics If you apply for this vacancy and have not received a communication from North Bristol NHS Trust within three weeks of the closing date, please assume that on this occasion your application has been unsuccessful. Please note that North Bristol NHS Trust does not reimburse travel expenses relating to interview attendance. For questions related to the Disability Act / Two Ticks scheme and required support, please contact us on tel 0117 414 1151. North Bristol NHS Trust are committed to safeguarding and promoting the welfare of children and young people and expects all staff and volunteers to share this commitment. The successful applicant(s) will normally commence at the minimum of the scale unless they have previous NHS service at the same band. Progression through the scale is by annual increments. Talent continuity At North Bristol Trust (NBT), we know diverse and inclusive environments lead to happier and healthier teams and improved patient care and outcomes. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are currently underrepresented in NBT’s workforce at Band 8a and above. These include people from Black, Asian and minority ethnic backgrounds, disabled people and LGBTQIA+ people. Pre‑employment checks Please note that stringent pre‑employment checks are undertaken on all successful applicants prior to commencement in post. #J-18808-Ljbffr
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Location:
Bristol
Job Type:
FullTime

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