Job summary
Are you a person who embraces the challenge of working in a busy environment as part of a friendly multi-skilled team?
We are looking for an enthusiastic and experienced individual for our B8a Quality Assurance Manager - 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 highly skilled, experienced and enthusiastic individual to Lead our 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 role plays an important part 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 be integral to this project as well as, in the future, being involved with the business case, design and development of a new permanent facility.
The Aseptic and Radiopharmacy departments both operate under S10, with one Accountable Pharmacist, although radiopharmacy is managed separately under Nuclear Medicine. With the planned future introduction of a new electronic Quality Management programme there is also a great opportunity to streamline and unify the quality services provided to both departments.
Main duties of the job
Being a Pharmacy Professional, the post-holder will lead the evolving Quality Team providing services to both the Aseptic & Radiopharmacy services at Cheltenham General Hospital.
They will ensure that all aspects of Quality Assurance are effectively managed to meet agreed Trust and Pharmacy Dept objectives as well as ensuring compliance with relevant legislation, regulations and guidelines.
They will manage the implementation & maintenance of the Pharmaceutical Quality Management System & monitor its effectiveness.
They will be professionally responsible for the development, management and co-ordination of staff within the Quality Assurance team, ensuring that education, training, validation and competency assessments are all relevant, up to date and of the appropriate standard.
Additional working pattern details: Mon-Fri 08:30 - 17:00
About us
Gloucestershire Hospitals NHS Foundation Trust (GHT) is one of the largest NHS trusts in the UK. Located between Birmingham (45 miles) and Bristol (32 miles), the beautiful Cotswolds and Forrest of Dean, the county is easily accessible by road including the M5 motorway, with convenient links to the M4 and the M50. Together with main line rail networks, this puts Gloucestershire within easy reach of many metropolitan areas and airports.
GHT supports staff with access to the well-being hub, exercise and activity classes and membership of our popular hospital choir.
The pharmacy department has over 200 staff across the two sites in Cheltenham and Gloucester, both sites provide full dispensary services, medicines information, procurement services and a full clinical service to wards. There is a regular free shuttle bus allowing easy transport between hospitals both of which are located in the city/town centres with access to shops and cafes.
The Pharmacy department is committed to supporting the Trust to deliver its vision of best care for everyone, we strive to provide the whole team with the necessary skills and ongoing support to make a real difference to patient care, include a program to develop prescribing roles within the department.
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
1. Responsible for implementing the pharmaceutical Quality Systems (PQS) aseptic and radiopharmacy services, critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
2. 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.
3. Working with the Assistant Pharmacy Director (Operational Pharmacy Services) to ensure governance of medical gas provision & systems, ensuring pharmacy input and adherence to Health Technical Memorandum (HTM) 02-01 and related patient safety alerts is achieved and reported to the Pharmacy Director.
4. To maintain and promote continuous improvement of the PQS.
5. To provide expert quality assurance advice to the Pharmacy Aseptic Unit (PAU) and Radiopharmacy senior staff
6. Provide assurance of compliance with standards in documents such as the QA of Aseptic Preparation Services (QAAPS), Quality Assurance of Radiopharmaceuticals, Guidance Note 14 and Yellow cover guide - Guidance of supervision as applied to Section10 Aseptic Units
For full details please also refer to attached job description including person specification.
Additional Contacts:
Amanda White (Accountable Pharmacist )
0300 422 3504
Kirsty Higgins (Radiopharmacy Manager)
0300 422 4037
The proposed interview date is: 17th September
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
1. Responsible for implementing the pharmaceutical Quality Systems (PQS) aseptic and radiopharmacy services, critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
2. 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.
3. Working with the Assistant Pharmacy Director (Operational Pharmacy Services) to ensure governance of medical gas provision & systems, ensuring pharmacy input and adherence to Health Technical Memorandum (HTM) 02-01 and related patient safety alerts is achieved and reported to the Pharmacy Director.
4. To maintain and promote continuous improvement of the PQS.
5. To provide expert quality assurance advice to the Pharmacy Aseptic Unit (PAU) and Radiopharmacy senior staff
6. Provide assurance of compliance with standards in documents such as the QA of Aseptic Preparation Services (QAAPS), Quality Assurance of Radiopharmaceuticals, Guidance Note 14 and Yellow cover guide - Guidance of supervision as applied to Section10 Aseptic Units
For full details please also refer to attached job description including person specification.
Additional Contacts:
Amanda White (Accountable Pharmacist )
0300 422 3504
Kirsty Higgins (Radiopharmacy Manager)
0300 422 4037
The proposed interview date is: 17th September
Person Specification
Qualifications
Essential
- Degree (or equivalent) in chemistry, life science, pharmacy, other relevant scientific subject or Qualified Pharmacy technician with suitable experience
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
- 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.
Knowledge
Essential
- Advanced knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Advanced 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
- Significant 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
- Proficient in the use of 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
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
- 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.
Knowledge
Essential
- Advanced knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Advanced 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
- Significant 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
- Proficient in the use of 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).
