Quality Systems Officer (QA & QC)

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 QAQC and the Senior QA Specialist 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, QC and all current relevant regulations to develop and maintain quality systems. The successful candidate shall work collaboratively to support the QA team in delivering outstanding QA and Technical services at the hospital. This is an ideal opportunity for someone looking to contribute to our renowned Quality Assurance services. The team currently provides comprehensive Quality Control (QC) services to external organisations as well as to the Technical Services (Aseptics and Cytotoxics), Prepack and Radiopharmacy department at St. George’s.

Main duties of the job:

• 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 teams.
• You must be able to demonstrate relevant quality assurance experience in a senior or mid-management 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).
• Previous experience in performing batch release would be beneficial; however, training will be given if needed, for the right candidate.
• You will be expected to work with a team of quality professionals to provide QA services 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.

Working for our organisation:

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.

Detailed job description and main responsibilities:

The position requires that you have a degree in pharmacy, pharmaceutical science, or other relevant scientific subject, or are a registered Pharmacy Technician. 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.

Person specification:

Qualifications and Training:

• Degree in Pharmacy, Pharmaceutical Science, Chemistry, Microbiology or other relevant Scientific discipline OR NVQ Pharmacy Services Level 3 or an accredited underpinning knowledge (BTEC in Pharmaceutical Sciences) or equivalent MSc/Diploma in Pharmaceutical Technology & Quality Assurance (PTQA)
• Registered with the GPhC
• Membership of the Royal Pharmaceutical Society of Gt Britain (RPS) or APTUK (Association of Pharmacy Technicians UK)
• Further qualification in relevant technical or management area

Experience:

• Demonstrable portfolio of relevant experience in pharmaceutical manufacturing, including experience in an aseptic manufacturing facility
• Experience of participation in external audit
• Experience in a QC laboratory and QA department
• Experience of managing and motivating staff
• Demonstrated expert technical knowledge covering Pharmaceutical QA and Production
• Demonstrated knowledge of principles and practices of aseptic/parenterals e.g. Formulation, stability, administration, legal issues
• Experience of staff training
• Experience of working under an MHRA licence
• Experience of hosting external auditors e.g. MHRA and EL auditors
• A thorough knowledge of Hospital Pharmacy Technical Services
• Previous experience of presentations and publications

Knowledge:

• 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.

Skills:

• Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems
• Demonstrated Project Management Skills
• Able to manage staff effectively including appraisal, sickness monitoring and HR policies
• Able to communicate complex, contentious and sensitive information effectively
• Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services
• Able to develop new systems of work
• Supervisory and training skills
• Able to write business cases

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.