Principal Pharmacy Technician Quality Assurance
Job overview
Principal Pharmacy Technician - Quality Assurance
To manage, lead and develop the Quality Assurance (QA) Service. Provide advice and information to healthcare professionals in specialist areas. Manage, train and develop staff allocated. Train other healthcare staff. Manage contracts and agreements for QA Services
Main duties of the job
To manage, lead and develop the QA Service. This will include the following:
Manage and develop Quality Assurance Services to ensure compliance adherence to the requirements of the MHRA Specials Manufacturing and Wholesaler Dealer Licences.
Provide professional and technical advice to ensure the NGH achieves the required QA standards (National, Regional, Professional etc) with respect to medicines.
Manage environmental monitoring under service specifications as necessary.
Fulfil the responsibilities of the ‘Releasing Officer’ for licensed manufacturing which will include the release of components used in manufacture and release of final product.
Facilitate the award and retention of MHRA licences.
Liaise with the MHRA Inspector to facilitate the GMP inspection.
Co-ordinate the production and implementation of an action plan following an MHRA inspection.
Attend the Quality Issues Network (QUIN) meetings and maintain links with the
Regional Quality Assurance Specialists to ensure in-house practices are in line with current national practice and legislation and as a means of maintaining personal knowledge.
Develop and manage systems to ensure that the purchase, assessment and supply of unlicensed medicines comply with current legislation.
To line manage staff, including recruitment, appointment and induction, performance and sickness management.
Please see job description for further information
Working for our organisation
Northampton General Hospital is one of the largest employers in the area and we are on an exciting journey. All of our divisions are committed to doing things better, with more efficiency as we update, modernise, and advance. We have also entered into a Group Model with neighbouring Kettering General Hospital NHS Foundation Trust and become University Hospitals of Northamptonshire.
Our Excellence Values
Compassion
Accountability
Respect
Integrity
Courage
We want to recruit the best people to deliver our services across the University Hospitals of Northamptonshire and help to unleash everyone’s full potential. As an organisation, we value how we communicate and promote our vacancies to all communities.
We are a Defence positive trust, supporting our reservists, veterans, spouses and partners.
The Hospital Group encourages applications from people who identify from all protected groups, especially those from BAME, Disabled and LGBTQ+ backgrounds as these are underrepresented in our hospitals.
We understand that we need to work with colleagues from diverse backgrounds and make sure the environment they work in is inclusive and collaborative.
We have active Networks that promote and support colleagues from all backgrounds. This ensures everyone feels supported and has a sense of belonging working for Kettering and Northampton General Hospitals.
Detailed job description and main responsibilities
To be responsible for Service Provision. This will include the following:
To be responsible for the ‘quality management system’ as described in the Manufacturing Site Master File.
To maintain a high level of expertise and the ability to, when necessary, undertake environmental monitoring in Aseptic Services and Radiopharmacy and at other organisations.
Audit Pharmacy and Radiopharmacy production, preparation and laboratory facilities and Pharmacy Stores to ensure that policies are implemented and practice standards/licence requirements are maintained.
Facilitate preparation, review and updating of specifications and standard operating procedures to use within Northampton General Hospital and in customer units as necessary with respect to medicines production.
Be responsible for the development and updating of QA policies and procedures.
Be responsible for the management of Pharmacy QA premises and maintenance and purchase of equipment ensuring that equipment is regularly serviced and calibrated.
Be responsible for the management and co-ordination of SLAs in relation to PPM across Pharmacy ASU and Radiopharmacy.
Be responsible for Pharmacy premises in terms of temperature monitoring and pest control.
Design validation programmes and undertake validation of equipment, processes and personnel.
Be responsible for the release of packaging components used in production and batches of product produced by the Production Unit.
Be responsible for the department’s response to MHRA/company led medicines recalls.
Ensure liaison with pharmaceutical companies and the MHRA regarding defective medicinal products or medical devices.
Please see Job description for further details
Person specification
Education, Training and Qualifications
Essential criteria- Life Sciences degree or BTEC in Pharmaceutical Sciences with further formal training/development of QA Services
- Registered with appropriate scientific body, eg GPhC
Skills
Essential criteria- Ability to use a range of computer applications
- Excellent oral and written communication skills
- Effective interpersonal skills
- Good analytical skills
- Good planning and organisational skills
Knowledge and Experience
Essential criteria- Extensive post qualification relevant Good Manufacturing Practice experience (typically at least 5 years)
- Experience of operating a Quality Management System
- Managing people and services
- Understanding of MHRA licencing requirements
- Understanding of the rules and regulations governing unlicensed medicines