Compounding Unit - Accountable Pharmacist
Healthcare at Home are currently recruiting for an Accountable Pharmacist top join our Burton Pharmacy Operation. This role will be responsible for delivering a safe, cost‑effective and efficient, patient-centred compounding service, including aseptically manufactured chemotherapy, monoclonal antibodies, CIVAS and other aseptically prepared items for the business.
To manage all compounding unit operations carried out across the company for service users, both within and outside the company within the income and staff resources available ensuring the service is profitable within the agreed income targets.
Healthcare at Home … a little about us...
Our vision is simple, we help our patients have their best day, every day.
Working alongside healthcare providers and pharmaceutical companies, we ensure first class clinical care in the home to our patients and provide greater insights and efficiencies to our customers.
Delivering through a patient centric approach, coupled with the introduction of user friendly technology, we provide clear visibility of the patient’s adherence and persistence, resulting in improved outcomes. All this contributes to supporting our customers to identify interventions which enables patients to rediscover ‘their normal’ and have their best day every day.
- To ensure balance between direct patient-care services to the company and commercial activities and to develop appropriate business management tools for the overall operation.
- To oversee all aspects of compounding unit facilities at the company.
- To provide effective leadership and expert knowledge across the enlarged company.
- Expert knowledge of all regulations, including MHRA requirements, GMP (Good Manufacturing Practice) and QA guidance is essential in this post. The post holder will be the named Production Manager / Quality Manager* on the MHRA licences.
- To provide a comprehensive compounding service to the company and ensure the continuity of patient care. This may include direct patient care activities as part of the clinical engagement.
- To provide technical and professional guidance on all matters relating to compounding activities
- To be responsible for the risk management of appropriate outsourcing of aseptic products including chemotherapy, CIVAS and TPN products purchased from external providers.
- To manage the compounding unit supervisor and all staff working in the compounding unit.
- To lead and explore opportunities for commercialisation for the compounding unit.
- The post holder will provide expert advice to the company on all legislative and regulatory Good Manufacturing Practice (GMP) requirements and in doing so actively participate in the maintenance and development of the Pharmacy Manufacturing Unit’s (PMUs) Quality Management Systems (QMS).
- In this role the post holder will support the senior management team to provide a high quality, safe, cost‑effective and efficient, patient-centred pharmacy production services to the company.
- The post holder will manage and be responsible for all IMP manufacturing operations carried out in the compounding unit. In doing so the post holder will ensure the IMP manufacturing service is profitable meeting all income targets, managing and controlling costs and ensuring staffing resources are utilised effectively.
- The post holder will lead and explore commercial opportunities for the manufacture of IMPs ensuring a balance between direct patient-care services to company and commercial activities and will develop appropriate business management tools for IMP manufacturing operations.
- The post holder will provide effective leadership and technical and professional guidance across the company in all aspects of GMP activities with expert knowledge of all legislative and regulatory requirements for the manufacture and preparation of medicinal products for human use.
Key duties & responsibilities
- To lead in all aspects pertaining to the management of the compounding unit.
- The post holder will be a Releasing Officer named in the compounding unit’s Quality Management System (QMS) and will make the final decision to approve or reject as he/she sees fit, starting materials, components, and pharmaceutical finished products for use within the compounding unit and for sale to other commercial and NHS healthcare providers under the company’s MHRA Manufacturers Specials (MS) licence.
- The post holder will make the final decision to approve or reject as he/she sees fit, medicinal products prepared in the compounding unit under Section 10 of the 1968 Medicines Act through Regulation 4 of the Human Medicines Regulations 2012 [SI 2012/1916].
- As a member of the senior management team, to help develop a strategic vision and delivery plan for the compounding unit services across the business.
- To maintain awareness and understanding of local and national and issues and legislation that affect compounding unit services.
- To provide professional leadership and management of staff in compounding unit in order to achieve the highest standards of pharmaceutical care, identifying and promoting on-going training programmes, ensuring staff are effectively empowered, motivated and competent, and have clear performance targets and reviews.
- To continually analyse and assess the provision of compounding unit services to the business, developing and implementing alternative methods of delivering these services based on business needs within a risk management framework of safe systems of work which minimises errors and irregularities and ensures high quality.
- To assist in the development and implementation of the company’s annual delivery plan as it relates to compounding services.
- To manage and be responsible for the compounding unit budget as it relates to compounding unit to achieve financial balance and lead on commercialisation projects and income generation activities for the compounding unit.
- To be the accountable pharmacist as defined by Quality Assurance Aseptic Preparation Services 5th Edition authorising all aspects of the services within the compounding unit, including the approval of all systems of work and documentation used in the unit.
- To ensure that all local, regional and national standards/guidance (including those produced by National Institute of Clinical Excellence (NICE) and National Safety organisations, MHRA are fully implemented within local practice.
- To attend EL(97)52 audits and MHRA inspections and respond to all deficiencies with action plans.
- To be responsible for developing and maintaining policies, procedures and guideline related to compounding in conjunction with the specialist lead chemotherapy pharmacists and for developing and maintaining the availability of these policies, procedures and guidelines for oncology staff as appropriate.
- To liaise closely and attend internal audit meeting with Quality Assurance pharmacy staff, to ensure that all practices comply with the latest guidance and nationally approved requirements for aseptic preparation, and to ensure that quality standards are maintained.
- To encourage and promote scientific and practice-based research within the compounding unit to reinforce the businesses reputation as a world leader.
- Support the national provision of manufactured pharmaceutical products in liaison with other lead and support units, co-ordinating and rationalising products in line with Department of Health NHS Manufacturing strategy.
- To manage all quality and production activities carried out compounding unit.
- In close liaison with quality control colleagues to ensure that licensed Production activities comply with nationally applicable Good Manufacturing Practice standards and local policies and procedures. To ensure full compliance as the Responsible Person for the licences.
- To develop and maintain contacts with service recipients to ensure services and products meet user requirements.
- To make plans as necessary for developments in Production facilities and equipment.
- In conjunction with clinical staff and other Pharmacy colleagues to assist in the research and development of novel pharmaceutical products.
- In conjunction with other clinical staff and industrial business partners to identify and develop products and services with specific patient applications and/or income generation potential, formulating relevant business plans.
- To provide technical advice to Pharmacy colleagues and others on the formulation, preparation and use of Pharmacy manufactured products.
- To maintain familiarity with basic dispensary and dispensing operations, especially those where there could be Production input.
- In liaison with the Senior Pharmacist - Clinical Trials to provide a leadership and management support for the provision of clinical trials to ensure that these services meet key performance standards and quality measures particularly where the input of Pharmacy Production services are required.
- To undertake and support the teaching of Technicians and Pharmacists undertaking NVQ, diploma and MSc work and in conjunction with the Pharmacy training team, provide teaching on relevant University courses.
- To assist in the recruitment of new staff to the Pharmacy Production team and to be involved in performance management of staff in the team.
- To participate in the provision of a clinical pharmacy service as appropriate
This will involve:
- assessing prescription charts in order to ensure safe rational and effective prescribing
- enabling use of patient’s own medicines and counselling to improve medication usage and patient understanding of medications
- making recommendations to improve effectiveness of drug therapy
- making recommendations about medications to improve patient outcomes and to encourage adherence to hospital formulary and national guidelines
- providing medications for individual patients during their stay in hospital and at discharge
- being accountable for adherence to all pharmacy policies and procedures relating to medicines management checking prescriptions, dispensed by others , for accuracy of supply , labelling and interpretation
- supervising sales of medicines from pharmacy shop
- To provide regular workload and usage data to enable review and planning of activities for the compounding unit.
- To develop a range of quality and key performance indicators for the compounding unit and provide audit against them.
- To develop comprehensive capacity planning and management indicators for the unit.
- Maintain contact with appropriate specialists and group both nationally and locally to enable best practice to be identified and incorporated into Trust practice.
- To undertake and document continuing professional development.
- To participate in rostered shift working including evening, weekend and bank holiday arrangements in line with service commitments.
- Undertake any other duties that may reasonably be required
- Generous salary and benefits package based on skills and experience
- 25 days annual leave + stat
- Market leading pension
- Flexible online benefits portal with numerous discounts and vouchers
- Cycle to work scheme
Healthcare at Home are an equal opportunities employer