Quality Assurance Specialist PharmacistUniversity College London Hospitals NHS Foundation Trust • London, England, United Kingdom
Quality Assurance Specialist Pharmacist
University College London Hospitals NHS Foundation Trust
- London, England, United Kingdom
- London, England, United Kingdom
Über
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 Pharmacist 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; good command in digital quality system and trust e‑prescribing system; and an enthusiastic, flexible and professional approach are all essential.
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.
Main duties of the job 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 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 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, undertaking other Trust projects and advice on a range of medicine or patient safety issues.
Person Specification Knowledge and Qualifications
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.
Specialist Qualification in Pharmaceutical Technical Services, e.g. PTQA MSc or equivalent experience and expertise
Working knowledge of quality aspects of Good Distribution Practice
Experience
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
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.
Experience of using electronic Quality Systems application such as QPulse.
Skills and Abilities
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
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
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
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.
University College London Hospitals NHS Foundation Trust
£64,156 to £71,148 a yearPer Annum Inclusive of HCAS
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Sprachkenntnisse
- English
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