Job summary
Are you a person who embraces the challenge of working in a busy environmentas part of a friendly multi-skilled team?
We are looking for an enthusiastic and experienced individual for our new B7 Quality Assurance Specialist - Aseptic & Radiopharmacy Services at Gloucestershire Hospitals NHS Foundation Trust, based at Cheltenham General Hospital, providing treatments to both Cheltenham and Gloucester hospitals. We provide SACT and radiopharmaceuticals , as well as dispensing outsourced items.
We are looking for a skilled, experienced and enthusiastic individual to joinour evolving quality team as we look toward the future, with the aim to develop our existing workforce as well as welcoming new members to the department.
This is a new post which will support the Quality Manager in driving quality improvement within both the aseptic and radiopharmacy departments.
It is an exciting time for the aseptic department with an imminent move into a temporary modular unit. The successful applicant will help support this project as well as, in the future, the development of a new permanent facility.
The Aseptic and Radiopharmacy departments both operate under S10, with oneAccountable Pharmacist, although radiopharmacy is managed separately underNuclear Medicine. With the planned future introduction of a new electronic Quality Management programme there is also a great opportunity to support the unification ofquality services provided to both departments.
Main duties of the job
Being a Pharmacy Professional, the post-holder will act as deputy to the Quality Manager, providing services to both the Aseptic & Radiopharmacy services at CheltenhamGeneral Hospital.
Ensure that all aspects of Quality Assurance are completed tomeet agreed Trust and Pharmacy Dept objectives as well as ensuring compliancewith relevant legislation, regulations and guidelines.
Implement and maintain the Pharmaceutical Quality Management System and monitor its effectiveness.
About us
Gloucestershire Hospitals NHS Foundation Trust (GHT) is one of the largest NHStrusts in the UK. Located between Birmingham (45 miles) and Bristol (32 miles), thebeautiful Cotswolds and Forrest of Dean, the county is easily accessible by roadincluding the M5 motorway, with convenient links to the M4 and the M50.Together with main line rail networks, this puts Gloucestershire within easy reachof many metropolitan areas and airports.
GHT supports staff with access to the well-being hub, exercise and activity classesand membership of our popular hospital choir.
The pharmacy department has over 200 staff across the two sites in Cheltenhamand Gloucester, both sites provide full dispensary services, medicines information,procurement services and a full clinical service to wards. There is a regular freeshuttle bus allowing easy transport between hospitals both of which are located inthe city/town centres with access to shops and cafes.
The Pharmacy department is committed to supporting the Trust to deliver itsvision of best care for everyone, we strive to provide the whole team with thenecessary skills and ongoing support to make a real difference to patient care,including a program to develop prescribing roles within the department.
Job description
Job responsibilities
1. Deputising for the Quality Assurance Manager, covering periods of absence, you will ensure provision of service, provide suitable advice, draft reports and undertake audits for their authorisation.
2. Support implementing the pharmaceutical Quality Systems (PQS)aseptic and radiopharmacy services, maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
3. Support the governance of medical gas and ventilation systems, ensuring pharmacy input and adherence to Health Technical Memorandum (HTM) 02-01 and HTM-03 and related patient safety alerts is achieved.
4. To keep abreast of all standards and guidelines relevant to the work of the Aseptic and Radiopharmacy departments. Update the Accountable Pharmacist and Pharmacy Director as appropriate.
5. To maintain and promote continuous improvement of the PQS.
6. To provide quality assurance advice to the Pharmacy Aseptic Unit (PAU) and Radiopharmacy senior staff.
For full details please also refer to attached job description including person specification
Contact Details
Amanda White (Accountable Pharmacist - Technical Services)
amanda.white@nhs.net
0300 422 3504
Kirsty Higgins (Radiopharmacy Manager)
0300 422 4037
Job description
Job responsibilities
1. Deputising for the Quality Assurance Manager, covering periods of absence, you will ensure provision of service, provide suitable advice, draft reports and undertake audits for their authorisation.
2. Support implementing the pharmaceutical Quality Systems (PQS)aseptic and radiopharmacy services, maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
3. Support the governance of medical gas and ventilation systems, ensuring pharmacy input and adherence to Health Technical Memorandum (HTM) 02-01 and HTM-03 and related patient safety alerts is achieved.
4. To keep abreast of all standards and guidelines relevant to the work of the Aseptic and Radiopharmacy departments. Update the Accountable Pharmacist and Pharmacy Director as appropriate.
5. To maintain and promote continuous improvement of the PQS.
6. To provide quality assurance advice to the Pharmacy Aseptic Unit (PAU) and Radiopharmacy senior staff.
For full details please also refer to attached job description including person specification
Contact Details
Amanda White (Accountable Pharmacist - Technical Services)
amanda.white@nhs.net
0300 422 3504
Kirsty Higgins (Radiopharmacy Manager)
0300 422 4037
Person Specification
Qualifications
Essential
- Degree (or equivalent) in chemistry, life science, pharmacy, other relevant scientific subject or Qualified Pharmacy technician with suitable experience
- Hold statutory professional registration or be eligible to register with relevant professional body (e.g. GPhC, HCPC, RSC, RBS) with knowledge of aseptic or radiopharmacy preparation or manufacturing services and quality control.
Desirable
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
Knowledge
Essential
- Knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Knowledge in pharmaceutical quality assurance including radiopharmaceuticals
- The audit process - internal and external. Change Management - Good knowledge of Pharmaceutical Microbiology - Operational Management Risk Management - Validation Requirements for facilities, equipment and products
Desirable
- Understanding of HTM 02-01: Medical gas pipeline systems Part A: Design, installation, validation and verification and HTM 02-01: Medical gas pipeline systems Part B:
Experience
Essential
- Experience Quality Assurance/Control Officer within a pharmaceutical manufacturing / preparation facility (or equivalent)
- Demonstrable experience in training staffs in quality assurance & quality control method
Desirable
- Experience of input into the design, business case, development, commissioning and validation of production facilities.
- Experience as Quality Assurance/Control Officer within a Radiopharmacy facility
- Experience using QMS supporting software such as Q-Pulse, iPassPort
- People management including performance, disciplinary and sickness management
Personal Attributes
Essential
- Prioritization, time management, personal effectiveness, influencing, analytical and problem-solving skills of a consistently high standard maintaining attention to detail and accuracy.
- Innovation/implementation skills to develop services in accordance accepted with standards
- Excellent communication (written, oral, presentations) and interpersonal skills essential to exchange highly complex information to colleagues, patients and relatives, clinicians and senior managers (both within and outside of the trust). Ability to take complex ideas and communicates to all levels of the service
- Evidence of continuing self-development relevant to role
Person Specification
Qualifications
Essential
- Degree (or equivalent) in chemistry, life science, pharmacy, other relevant scientific subject or Qualified Pharmacy technician with suitable experience
- Hold statutory professional registration or be eligible to register with relevant professional body (e.g. GPhC, HCPC, RSC, RBS) with knowledge of aseptic or radiopharmacy preparation or manufacturing services and quality control.
Desirable
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
Knowledge
Essential
- Knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Knowledge in pharmaceutical quality assurance including radiopharmaceuticals
- The audit process - internal and external. Change Management - Good knowledge of Pharmaceutical Microbiology - Operational Management Risk Management - Validation Requirements for facilities, equipment and products
Desirable
- Understanding of HTM 02-01: Medical gas pipeline systems Part A: Design, installation, validation and verification and HTM 02-01: Medical gas pipeline systems Part B:
Experience
Essential
- Experience Quality Assurance/Control Officer within a pharmaceutical manufacturing / preparation facility (or equivalent)
- Demonstrable experience in training staffs in quality assurance & quality control method
Desirable
- Experience of input into the design, business case, development, commissioning and validation of production facilities.
- Experience as Quality Assurance/Control Officer within a Radiopharmacy facility
- Experience using QMS supporting software such as Q-Pulse, iPassPort
- People management including performance, disciplinary and sickness management
Personal Attributes
Essential
- Prioritization, time management, personal effectiveness, influencing, analytical and problem-solving skills of a consistently high standard maintaining attention to detail and accuracy.
- Innovation/implementation skills to develop services in accordance accepted with standards
- Excellent communication (written, oral, presentations) and interpersonal skills essential to exchange highly complex information to colleagues, patients and relatives, clinicians and senior managers (both within and outside of the trust). Ability to take complex ideas and communicates to all levels of the service
- Evidence of continuing self-development relevant to role
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).