Liverpool University Hospitals NHS Foundation Trust
Aseptic Production Unit - Royal Liverpool University Hospital
Band 8A + EDC Full time (37.5 hours per week)
We are a major acute teaching Trust offering a wide range of clinical specialities, including tertiary referrals for HIV and Renal Medicine.
Pharmacy at LUHFT has a highly regarded Aseptic Production Unit (APU) with a brand-new Manufacturing site licensed in June 2023.
Your input will be vital in the development of facilities, production processes, service delivery, workforce configuration & growth. You will contribute to all production related elements at site and ensure that quality is at the centre of everything we do for our patients across the NHS and private healthcare settings.
With significant experience of managing a technically trained team within a GMP healthcare setting, the post holder will be capable of working under pressure, prioritising to deadlines and multi-tasking.
The post provides an ideal opportunity to further develop specialist technical skills. If you are a forward-thinking and innovative pharmacist, with a desire to embrace new challenges, why not join us in Liverpool.
Main duties of the job
The post holder will contribute to overseeing the operational quality aspects of all production processes, in a cost effective and operationally efficient manner and for assuring the quality of all unlicensed medicines manufactured and prepared within Royal Liverpool Pharmaceuticals (RLP).
After a period of training and assessment the post holder will be named as a releasing officer in the Quality Manual and Site Master File.
Job responsibilities
The post holder will be responsible for communication with all key stakeholders in the supply of all Specials (Unlicensed Medicines) prepared within the Aseptic Production Unit. This will include internal and external customers, patients, staff and other healthcare professionals.
Lead on Operational Quality matters such as microbiological and physical environmental monitoring, Component and Consumable assessments, raw material quality assessment and approval for use within manufacture and preparation of medicines.
Review and update PMU policies and procedures, in light of changes to legislation and Trust Policy or process changes at site instigated via change control mechanisms.
Provides specialist clinical & technical advice to doctors, pharmacists and other healthcare professionals on delivery of intravenous Nutrition, CIVAS products & chemotherapy for Adults & Children.
Person Specification
Qualifications
* Registered General Pharmaceutical Council (GPhC) Member.
* Post graduate certificate or diploma in a relevant pharmaceutical field or equivalent knowledge and skills developed via on job training.
* Highly developed Professional knowledge, underpinned by theory and experience.
* APDM course.
* Postgraduate diploma/Msc (specialization) in Technical Pharmacy or equivalent.
* MSc (clinical)/(technical) Pharmacy.
* Management Certificate or Diploma.
Experience
* Demonstrable experience of putting knowledge into practice via working within clean room GMP environments and working within GMP/GDP guidelines either in a hospital or industrial environment.
* Experience of product development.
* Evidence of staff management and training.
* Experience of design and qualification of clean room facilities.
* Experience of Self Inspection & External Audit /Inspection.
Knowledge
* Extensive knowledge of Good Manufacturing Practice and the regulations surrounding Pharmaceutical Manufacture.
* Knowledge of clean room design, functioning and commissioning.
* An understanding of medicines management procedures.
* Specialist knowledge of Pharmaceutical Manufacturing Processes including equipment and facility design, construction, validation and testing.
* Knowledge and experience of Aseptic preparation of medicines and Terminal Sterilization processes.
* Knowledge of the ISO 9000 Quality System.
Skills
* Leadership and motivational skills.
* Problem solving and analytical skills.
* Planning and organizational skills; ability to prioritize demands on service and plan workload of self and others.
* Highly developed interpersonal and communication skills; ability to communicate with a range of people such as technicians, pharmacists, engineers, clinicians and customers.
* Ability to work to deadlines and meet set targets.
* Ability to perform calculations to a high degree of accuracy.
* Persuasive and ability to negotiate.
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.
Address
Royal Liverpool University Hospital
Pharmacy, Level 2 – Clinical Support Services Building (CSSB), Mount Vernon street
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