University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Are you a Pharmacist, Technician, Healthcare Scientist or Scientist working in Pharmacy or Pharmaceutical Quality Assurance with experience in Quality Management?
A fantastic opportunity has become available to join our close-knit Quality Assurance team based at the Bristol Royal Infirmary and lead a small, dedicated team in implementing, maintaining and managing the electronic Quality Management System (Ideagen Quality Management (IQM) - formally known as Q-Pulse). Alongside this, you will work closely with healthcare professionals in the QA team to offer advice, support and guidance to our MS licensed Pharmacy Production and Radiopharmacy units, licensed Pharmacy stores, unlicensed Parenteral Services Unit and the wider pharmacy team.
We are committed to supporting staff development, as such you will be provided with full in-house training and given the opportunity to undertake funded training opportunities linked to your personal development.
Main duties of the job
The post holder will:
1. Lead the design, configuration, qualification/revalidation, implementation, management and development of the pharmaceutical quality management system.
2. Be a key member of the Quality Assurance team providing advice on quality matters to the Trust pharmacy teams.
3. Work collaboratively with other senior managers within pharmacy to develop policies and standard operating procedures to deliver the quality objectives of the department.
4. Support the Quality Control releasing officers in the approval of licensed batches and bespoke products.
About us
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England. UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond.
As a forward-thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer.
UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them.
Job responsibilities
Main responsibilities:
1. The Pharmacy Quality Systems Manager will be a key member of the Quality Assurance team charged with the design, configuration, qualification/(re)validation, implementation, management and development of the pharmaceutical quality management system. The prime objective is to ensure that the department becomes progressively more effective in quality terms and meets regulatory requirements.
2. To report to the Associate Director of Pharmacy, Quality Assurance and senior pharmacy managers at the level which decisions are made on policy, objectives and resources/finance based upon quality management performance and the need for further improvements.
3. The Pharmacy Quality Systems Manager will have the skills and ability to train and provide mentorship on the quality system and to promote the application of quality management. Modern electronic methods of Quality Management and quality/process control are central to standardised, effective and safe pharmaceutical services. These are vital to governance and risk management across these services.
4. The responsibilities cover all aspects of the pharmaceutical service and are not restricted to any particular discipline.
5. Processes in Pharmacy are varied and complex and the post-holder is expected to understand these and will need to use judgement skills to interpolate these with requirements to meet all the relevant and stringent quality standards.
6. To achieve this will require exceptional communication, judgmental, analytical, influencing, planning and organisational skills, being required to work with all grades of pharmacy, technical, and managerial staff.
7. To co-ordinate the Quality Assurance leads within each Pharmacy Technical Services discipline and form an effective, collaborative team to deliver the quality objectives of the department.
8. To ensure that Pharmacy staff are aware of their quality responsibilities and are equipped with an appropriate knowledge relevant quality standards and requirements (e.g. GMP, GDP).
Person Specification
Knowledge & Experience
* Experience and Knowledge of Quality Management Systems
* Substantial experience and knowledge of regulatory guidance and standards relating to pharmaceutical quality management (e.g. GMP, GDP and ICH Q10)
* Substantial experience and knowledge of risk management
* Experience in change management
* Experience in audit
* Experience in the validation of computerised systems
* Experience in training and presenting
* Hospital pharmaceutical QA/QC and/or manufacturing/aseptic preparation service experience
Skills and abilities
* Exhibit a high level of professionalism
* Ability to communicate clearly and present ideas to large groups of people, small teams and on a one-to-one basis verbally and in a written format
* Ability to liaise with and influence people in a professional manner
* Methodical approach with a good attention to detail
* Statistical analysis skills
* Exceptional communication, time management and prioritisation skills
* Able to make decisions and work independently
* Able to be helpful, work collaboratively and supportive within a team
* Respectful of others, non-judgemental, treat everyone as an individual and motivated to be genuinely kind and caring
* Willing to learn, open to change
* Good leadership skills
Qualifications and Training
* Relevant science Degree
* Masters or equivalent qualification in quality assurance or another aspect of Pharmacy Technical Services
* Registration/eligible to be registered with named professional bodies
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.
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