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Job summary
An exciting opportunity has arisen for an experienced, dynamic and enthusiastic Pharmacy QA professional to join the Pharmacy QA team at UCLH, to support the delivery of the pharmacy aseptic, repack, distribution and clinical trial services, as well as the wider pharmacy services at UCLH.
You will be an experienced and dynamic Pharmacy QA professional with demonstrable knowledge of both Quality Assurance and GMP, and the desire and ability to deliver high quality pharmacy services to patients at UCLH. You will have: GMP and Pharmacy Quality Assurance service experience within the NHS; working knowledge of GCP and GDP requirements; and experience of dealing with the MHRA and/or other external auditing agencies. Excellent team working, communication and negotiation skills; the ability to deliver and work as an integral part of the pharmacy QA team; well-developed team and lone-working skills; and an enthusiastic, flexible and professional approach are all essential.
Main duties of the job
The principal responsibilities of the post holder are to support the maintenance of the Quality Management System, to track and monitor Quality Indicators, approve new or updated product lines used within the aseptic and repack units, and deputise for the Pharmacy QA Lead.
The UCLH Pharmacy QA service supports the aseptic production service, which holds a MHRA MS licence and includes aseptic units for chemotherapy and CIVAS/PN, the repack production service, which holds a MHRA MS and MIA(IMP) license, providing overlabelled, repacks, kits and boxes to UCLH and a large range of external NHS Trusts, and the Brewery Road Wholesale Distributer, which holds a MHRA WDA(H) license and provides services to UCLH and the a number of other external NHS Trusts and private services. In addition the service provides support to a wide range of other pharmacy services including support for the pharmacy clinical trial unit, unlicensed medicine approvals, management of pharmacy recalls, provision of temperature monitoring systems, and advice on a range of medicine or patient safety issues.
UCLH is one of the most complex NHS trusts in the UK, serving a large and diverse population from the local area and throughout the United Kingdom and overseas. The Trust mission is to deliver top-quality patient care, excellent education and world-class research across seven hospitals.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
National Hospital for Neurology and Neurosurgery
Royal National ENT and Eastman Dental Hospitals
University College Hospital Grafton Way Building
Royal London Hospital for Integrated Medicine
University College Hospital Macmillan Cancer Centre
The Hospital for Tropical Diseases
University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
Person Specification
Knowledge and Qualifications
Essential
MPharm , Degree Level or equivalent qualification with proven experience working in pharmaceutical or related field Pharmacist Registration with the General Pharmaceutical Council (Pharmacist applicants) Detailed knowledge of GMP and GCP, current legislation and regulations; and ability to apply this knowledge to develop and run Quality Assurance services. Expert knowledge of pharmaceutical aspects of quality assurance with particular reference to aseptic production and practice. Well-developed IT skills and use of IT to manage and monitor quality systems.
Desirable
Specialist Qualification in Pharmaceutical Technical Services, PTQA MSc or equivalent experience and expertise Working knowledge of quality aspects of Good Distribution Practice
Experience
Essential
Demonstrable work experience in hospital pharmacy practice Demonstrable experience of aseptic manufacture (Chemotherapy, CIVAS and PN) Demonstrable experience of pharmacy Clinical Trials Experience in quality systems in a pharmaceutical setting Experience of managing non- compliances and incidents and developing and delivering action plans Experience of managing change in a pharmaceutical setting Experience of quality audits and demonstrable evidence of use of findings to improve practice Involvement in external and regulatory audits Awareness of current national standards, guidelines and service delivery issues relevant to pharmaceutical quality assurance Experience of using electronic Quality Systems application such as QPulse.
Desirable
Demonstrable significant experience of repack manufacture Experience of acting as delegated Releasing Officer under the Specials' License Experience of acting as Pharmacist Releasing Officer under the Section 10 exception under the Human Medicines Regulations.
Skills and Abilities
Essential
Demonstrated accurate numeracy skills, without using a calculator. Ability to identify GMP, GDP & GCP related problems and propose solutions with sound technical judgement Able to prepare and complete documentation accurately with attention to detail, even when under pressure Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes Flexibility with regard to changes in work schedules
Communication
Essential
Demonstrable ability to work effectively independently or as part of a team Able to communicate complex, contentious and sensitive information effectively when using clear written and spoken English Ability to communicate effectively with colleagues at all levels both within and beyond pharmacy and the trust. Leads by example, promoting the highest standards of personal and professional conduct, integrity and probity
Personal and People Development
Essential
Awareness of the needs of confidentiality Awareness of equal opportunities Demonstrated ability to manage load handling issues and ensure manual handling risk assessments for all activities within production