We have a fabulous opportunity for an experienced Quality Assurance Lead to join our team at Preston Pharmaceuticals in Lancashire Teaching Hospitals NHS Foundation Trust.
This role will lead on all aspects of delivery, development and operation of an effective pharmacy manufacturing unit (PMU) and offer vital support in key aspects of the Pharmacy wide quality agenda. The PMU operates under the name of Preston Pharmaceuticals (PP) and encompasses Non Sterile Medicines manufacture, assembly, Radiopharmacy and Aseptic Services and an Extemporaneous Dispensing Service, to meet the clinical needs of patients both at the Trust and across the NHS. The successful individual will be named as the nominated Head of Quality on our MHRA specials licence.
We are seeking a motivated individual who demonstrates commitment, accountability and is a positive role model for our Quality Assurance and wider Production Teams.
If you think this is the role for you, then please get in touch, introduce yourself and find out more about why Lancashire Teaching Hospitals NHS Foundation Trust is a great place to work!
You will have excellent proven leadership capabilities and technical expertise, essential for creating, improving and sustaining the safety, quality and efficiency of our services and the Quality Management System to ensure we maintain compliance with Good Manufacturing Practice, regulatory and legislative requirements.
This is an exciting time for Aseptic Services with NHSE’s future plans for transformation and investment. This post holder will be instrumental in helping to inform and shape aseptic services for the Trust and across the ICS in the advent of future hub and spoke models, ensuring that quality assurance and patient safety will be at the heart of everything to we do.
We value the personal skills, experiences and qualities that individuals bring to our department and the Trust; creating an inclusive working environment to attract talented people who feel motivated, involved and able to influence the future direction of our services. The wellbeing of staff is important to us; we have a dedicated Health and Wellbeing team who provide support on a range of topics, run fitness classes and organise mindfulness sessions. As an employer we have earned a reputation for focusing on the development of our staff and for being an organisation people are proud to work for.
We have 10,000 fantastic people working hard to deliver quality services to our patients. Whatever your role, you help look after 370,000 people in our local area & give specialist care to 1.5 million people across Lancashire & Cumbria.
Working with us gives you the knowledge and sense of pride that every activity you do genuinely does make a difference to support our patients & staff, ensuring we keep thriving & delivering outstanding healthcare right across our local towns.
You’ll have access to varied development opportunities, learn new skills, meet fab people & do things you’d never have done. You’ll learn about working in a hospital, interacting with people from all different roles to build skills & enhance your career path.
You’ll make an impact, be challenged to think differently, be bold & help innovate to keep improving things. Everything we do centres around patient care which means your role is pivotal and something really to be proud of.
Duites include, but are not limited to:
- To provide a comprehensive and high level Quality Assurance function to Pharmacy Manufacturing Unit
- To be named and perform the role of Quality Controller as nominated on the MHRA specials license
- Work proactively with the QA and Production Teams, Head of Production, Assistant Directors of Pharmacy, Chief Pharmacist, Department Leads and Trust Business Partners
- Demonstrates effective partnership working both within and outside of the organisation
- Participates in regional and national peer groups
- To develop Quality Systems to meet the changing needs and demands of the PMU and of external Regulators (eg: MHRA)
- To contribute to the planning and design of new and upgraded facilities within the PMU
- To ensure that planning, design, building, commissioning of new and upgraded pharmaceutical preparation facilities are carried out in accordance with Good Manufacturing Practice in order to meet regulatory standards
- To develop, write and present business cases for equipment, staff resources and service developments within Pharmaceutical QA and QC Services
- To provide advice to Assisant Director of Pharmacy and Head of Production in the determination of policy and plans for PMU services
- To lead on the risk assessment and documentation of major changes to be made to Pharmacy Technical Services.
- Contribute to the development of a strategic vision for the pharmacy service.
- Advise the Chief Pharmacist of the impact of the strategic plans of other services where there are implications for the PMU services or the medicines optimization agenda.
- To lead and manage QA Team, including objective setting, appraisals, performance and attendance monitoring
- Undertake workforce/capacity planning and skills mix reviews ensuring staff resources are used optimally and staffing levels and capabilities are maintained at safe levels at all times.
- To be responsible for recruitment of staff to QA Team, including advertising, short-listing, interviewing and selecting staff
- Development of new roles and reviewing person specifications and job descriptions for submission for AFC banding
- To develop training programmes for QA Team to ensure GMP compliance of Quality Services
- ensure training and assessment of all releasing officers within the PMU
- To undertake and manage Trust HR procedures in respect of discipline, grievances and sickness absence
- To participate in the training of pharmacists, scientists, pre-registration pharmacy graduates, technicians, and student pharmacy technicians as required
- To manage all resources within Quality Assurance in line with Trust Standing Financial Instructions
- To be responsible for the purchase of new and replacement equipment.
- To be responsible for the specifications, sourcing, price negotiation, installation, maintenance and repair of such equipment
- To be responsible for the purchase of consumables for Quality Assurance and Quality Control
- To undertake, supervise and give guidance on research projects arising from the work of technical services.
- To publish research and development work
- To participate in investigations into the formulae used in the Production Unit, and into the determination of stability and shelf life
- Accountable for the product development portfolio with respect to the development, risk management, formulation and validation of new products in response to clinical need including ensuring compliance with Product Lifecycle regulatory requirements
- Direct the product development programme ensuring regular liaison with all key stakeholders, including customers, PMU production, QA and customer services teams and outsourced QC services
- To be responsible for QA and QC advice and necessary support for Clinical Trials activities in the PMU in accordance with the statutory requirements for Good Clinical Practice
- To establish, monitor and review QA Standard Operating Procedures
- To monitor, review and approve, specifications for starting materials, finished products, packaging materials
- To monitor, review and approve manufacturing documents and Standard Operating Procedures
- Ensures that a system is in place such that stability data is established and that relevant records are maintained to support product shelf lives.
- To assist in the development and management of Technical Agreements for the provision of services to PMU by external companies
- To act as Releasing Officer for components, starting materials and finished products used by or prepared with the PMU
- To examine components, starting materials and finished products for compliance with specifications and to release or reject each batch as appropriate
- To manage and coordinate the response to the remote temperature monitoring system across the Pharmacy department