Senior Quality Control and Quality Assurance Specialist (Pharmacy)
St George's University Hospitals NHS Foundation Trust
An exciting opportunity has arisen within our Pharmacy QA team. We are looking for a motivated and enthusiastic quality professional to support the provision of Pharmacy Quality Assurance services. The individual will be required to support the Pharmacy Lead QA / QC in managing, delivering and developing the pharmaceutical QA and Quality Control Services to the Trust and external sites. Therefore, it is essential that they have experience in quality assurance and aseptic production, managing change, identifying and managing risk and audit. We require someone with good knowledge of Good Manufacturing Practice, QA and all current relevant regulations to develop and maintain quality systems. The successful candidate shall work collaboratively to support the QA/QC Lead and Technical Services Lead in delivering outstanding QA and Technical services at the hospital. The position requires that you have professional registration with the General Pharmaceutical Council (GPhC), and are able to demonstrate sufficient experience working in a senior QA role. You should possess excellent communication skills, be organised, and be able to demonstrate that you can motivate a team. You must have initiative, be forward thinking and have excellent attention to detail. Main duties of the job
This is an ideal opportunity for someone looking to contribute to our renowned Quality Assurance services. The team currently provides comprehensive Quality Assurance (QA) and Quality Control (QC) services to more than 20 external organisations as well as to the Technical Services (Aseptics and Cytotoxics), Prepack and Radiopharmacy department at St. George's. The Pharmacy department holds a WDA(H) licence, as well as an MHRA Specials licence for Prepack, Radiopharmacy and Non-sterile departments. You will be expected to work with and lead a team of quality professionals to provide a high quality service to internal and external service users. You will play an important role in the day to day delivery of high quality services ensuring that this meets local and national regulatory, safety and financial targets. As an integral member of the Pharmacy QA Team, you will need to demonstrate experience in Pharmaceutical microbiology as pertains to cleanrooms as well as sound scientific knowledge in order to be able to support the QC Microbiology and Chemistry team. You must be able to demonstrate relevant quality assurance experience in a senior role. The Postholder will be required to be a releasing officer for batches manufactured under the Trust's MHRA Specials license (Prepack, Non-sterile, Radiopharmacy). Therefore, previous experience in performing batch release is required. About us
The GESH hospital group is a leading healthcare provider in South-West London, comprised of St George's University Hospitals and Epsom and St Helier University Hospitals. Our vision is to provide outstanding care, together, by collaborating and working in partnership to meet the needs of our patients, and making sure our services are affordable and fit for the future. As GESH partners the pharmacy departments at St Georges University Hospital and Epsom & St Helier University Hospitals are working together in a number of areas including workforce, key functions such as medication safety, education and training and digital workstreams. St George's University Hospitals NHS Foundation Trust itself is a major acute hospital that offers specialist care for complex injuries and illnesses, including trauma, neurology, neurosurgery, cardiac care, lipid disorders, renal transplantation, cancer care and stroke. We are the regional specialist care provider for South-West London, Surrey and beyond. Acute and tertiary health services are delivered from over 1,000 beds across two sites, by around 8,000 staff. Job responsibilities
Please see attached the job description for more details on the main responsibilities for this role. Person Specification
Qualifications
MSc / Diploma, or equivalent experience Professional registration with the General Pharmaceutical Council (GPhC) Mandatory CPD to maintain fitness to practice. Education and Training qualification Eligible to be nominated as Qualified Person under permanent provisions 2001/83/EC Membership of the Royal Pharmaceutical Society of Great Britain (RPS) Further qualification in relevant technical or management area MSc/Diploma in Pharmaceutical Technology & Quality Assurance (PTQA) or equivalent experience Experience
Significant demonstrable portfolio of relevant experience in QC / QA or pharmaceutical manufacturing, including experience in aseptic production and in a licensed facility Experience of participation in audit Experience in managing change Experience in managing risk Experience in a QC laboratory and QA department Experience in performing batch release Experience of managing and developing a Pharmaceutical Quality Assurance Service Demonstrated expert technical knowledge covering Pharmaceutical QA and Production Experience of staff training Experience of hosting external auditors e.g. MHRA and EL auditors. Experience of presentations and publications Knowledge
Good, up to date knowledge of drug use Aseptic preparation and GMP Expert knowledge and the ability to provide highly specialised information on current legislation and guidelines on all aspects of quality assurance relating to pharmaceutical manufacture and production A thorough understanding of local/regional/national priorities in pharmaceutical quality assurance Demonstrable knowledge of the validation requirements for pharmaceutical production facilities, equipment, personnel and processes Knowledge of JAC computer system. Familiarity with hospital pharmacy dispensary systems Skills
Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems Demonstrated Project Management Skills Able to motivate staff Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services Supervisory and training skills Able to write business cases 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. Salary
£61,927 to £68,676 per annum including inner London HCAS Contract
Permanent Working pattern
Full-time Reference number
200-NN-6754878-BC-Z-A Job locations
St Georges University Hospitals NHS Foundation Trust
#J-18808-Ljbffr
St George's University Hospitals NHS Foundation Trust
An exciting opportunity has arisen within our Pharmacy QA team. We are looking for a motivated and enthusiastic quality professional to support the provision of Pharmacy Quality Assurance services. The individual will be required to support the Pharmacy Lead QA / QC in managing, delivering and developing the pharmaceutical QA and Quality Control Services to the Trust and external sites. Therefore, it is essential that they have experience in quality assurance and aseptic production, managing change, identifying and managing risk and audit. We require someone with good knowledge of Good Manufacturing Practice, QA and all current relevant regulations to develop and maintain quality systems. The successful candidate shall work collaboratively to support the QA/QC Lead and Technical Services Lead in delivering outstanding QA and Technical services at the hospital. The position requires that you have professional registration with the General Pharmaceutical Council (GPhC), and are able to demonstrate sufficient experience working in a senior QA role. You should possess excellent communication skills, be organised, and be able to demonstrate that you can motivate a team. You must have initiative, be forward thinking and have excellent attention to detail. Main duties of the job
This is an ideal opportunity for someone looking to contribute to our renowned Quality Assurance services. The team currently provides comprehensive Quality Assurance (QA) and Quality Control (QC) services to more than 20 external organisations as well as to the Technical Services (Aseptics and Cytotoxics), Prepack and Radiopharmacy department at St. George's. The Pharmacy department holds a WDA(H) licence, as well as an MHRA Specials licence for Prepack, Radiopharmacy and Non-sterile departments. You will be expected to work with and lead a team of quality professionals to provide a high quality service to internal and external service users. You will play an important role in the day to day delivery of high quality services ensuring that this meets local and national regulatory, safety and financial targets. As an integral member of the Pharmacy QA Team, you will need to demonstrate experience in Pharmaceutical microbiology as pertains to cleanrooms as well as sound scientific knowledge in order to be able to support the QC Microbiology and Chemistry team. You must be able to demonstrate relevant quality assurance experience in a senior role. The Postholder will be required to be a releasing officer for batches manufactured under the Trust's MHRA Specials license (Prepack, Non-sterile, Radiopharmacy). Therefore, previous experience in performing batch release is required. About us
The GESH hospital group is a leading healthcare provider in South-West London, comprised of St George's University Hospitals and Epsom and St Helier University Hospitals. Our vision is to provide outstanding care, together, by collaborating and working in partnership to meet the needs of our patients, and making sure our services are affordable and fit for the future. As GESH partners the pharmacy departments at St Georges University Hospital and Epsom & St Helier University Hospitals are working together in a number of areas including workforce, key functions such as medication safety, education and training and digital workstreams. St George's University Hospitals NHS Foundation Trust itself is a major acute hospital that offers specialist care for complex injuries and illnesses, including trauma, neurology, neurosurgery, cardiac care, lipid disorders, renal transplantation, cancer care and stroke. We are the regional specialist care provider for South-West London, Surrey and beyond. Acute and tertiary health services are delivered from over 1,000 beds across two sites, by around 8,000 staff. Job responsibilities
Please see attached the job description for more details on the main responsibilities for this role. Person Specification
Qualifications
MSc / Diploma, or equivalent experience Professional registration with the General Pharmaceutical Council (GPhC) Mandatory CPD to maintain fitness to practice. Education and Training qualification Eligible to be nominated as Qualified Person under permanent provisions 2001/83/EC Membership of the Royal Pharmaceutical Society of Great Britain (RPS) Further qualification in relevant technical or management area MSc/Diploma in Pharmaceutical Technology & Quality Assurance (PTQA) or equivalent experience Experience
Significant demonstrable portfolio of relevant experience in QC / QA or pharmaceutical manufacturing, including experience in aseptic production and in a licensed facility Experience of participation in audit Experience in managing change Experience in managing risk Experience in a QC laboratory and QA department Experience in performing batch release Experience of managing and developing a Pharmaceutical Quality Assurance Service Demonstrated expert technical knowledge covering Pharmaceutical QA and Production Experience of staff training Experience of hosting external auditors e.g. MHRA and EL auditors. Experience of presentations and publications Knowledge
Good, up to date knowledge of drug use Aseptic preparation and GMP Expert knowledge and the ability to provide highly specialised information on current legislation and guidelines on all aspects of quality assurance relating to pharmaceutical manufacture and production A thorough understanding of local/regional/national priorities in pharmaceutical quality assurance Demonstrable knowledge of the validation requirements for pharmaceutical production facilities, equipment, personnel and processes Knowledge of JAC computer system. Familiarity with hospital pharmacy dispensary systems Skills
Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems Demonstrated Project Management Skills Able to motivate staff Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services Supervisory and training skills Able to write business cases 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. Salary
£61,927 to £68,676 per annum including inner London HCAS Contract
Permanent Working pattern
Full-time Reference number
200-NN-6754878-BC-Z-A Job locations
St Georges University Hospitals NHS Foundation Trust
#J-18808-Ljbffr
