St George's Healthcare NHS Foundation Trust

Quality Systems Officer (QA and QC)

Information:

This job is now closed

Job summary

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 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 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.

Main duties of the job

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 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.

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 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). Therefore, previous experience in performing batch release would be beneficial; however, training will be given if needed, for the right candidate.

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

About us

St. George's University Hospitals NHS Foundation Trust is the regional specialist care provider for South west London, Surrey and beyond. The Trust provides a high quality, comprehensive range of health services from leading edge tertiary and trauma care to community services, delivered from 2 hospital sites, St. George's Hospital in Tooting and Queen Mary's Hospital in Roehampton. We also provide healthcare services at St. John's Therapy Centre, various health centres and clinics, GP surgeries, schools, nurseries, community centres and people's own homes. The Trust also manages the healthcare service at HMP Wandsworth. St George's University Hospitals NHS Foundation Trust serves a population of 1.3 million across southwest London. A large number of services, such as cardiothoracic medicine and surgery, neurosciences and renal transplantation, also cover significant populations from Surrey and Sussex, totalling around 3.5 million people.

The Pharmacy department has over 250 staff and enjoys an excellent reputation within the Trust. Over recent years there has been a £5.5m investment in facilities, including robotics and state of the art dispensaries and Technical services. The department is friendly, forward thinking and constantly expanding with opportunities for personal development and further postgraduate education. We are proud to be an accredited centre for the delivery of the Diploma in General Pharmacy Practice.

Details

Date posted

16 August 2023

Pay scheme

Agenda for change

Band

Band 7

Salary

£51,488 to £57,802 a year Per annum including inner london HCAS

Contract

Permanent

Working pattern

Full-time

Reference number

200-551187-DK-Z

Job locations

St Georges University Hospitals NHS Foundation Trust

Tooting

SW17 0QT


Job description

Job responsibilities

Please see attached the job description for more details on the main responsibilities for this role.

Job description

Job responsibilities

Please see attached the job description for more details on the main responsibilities for this role.

Person Specification

Qualifications

Essential

  • Degree in Pharmacy, Pharmaceutical Science, Chemistry, Microbiology or other relevant Scientific discipline

Desirable

  • Master in Pharmacy degree (MPharm)
  • 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

Essential

  • Demonstrable portfolio of relevant postgraduate 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

Desirable

  • 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 (e.g. clean room design, isolator technology and production methodology etc.)

Skills

Essential

  • Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems
  • Demonstrated Project Management Skills
  • Able to communicate complex, contentious and sensitive information effectively using clear written and spoken English
  • Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services

Desirable

  • Able to prepare and complete documentation accurately with attention to detail, even when under pressure

Knowledge

Essential

  • 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

Desirable

  • Knowledge of JAC computer system.
Person Specification

Qualifications

Essential

  • Degree in Pharmacy, Pharmaceutical Science, Chemistry, Microbiology or other relevant Scientific discipline

Desirable

  • Master in Pharmacy degree (MPharm)
  • 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

Essential

  • Demonstrable portfolio of relevant postgraduate 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

Desirable

  • 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 (e.g. clean room design, isolator technology and production methodology etc.)

Skills

Essential

  • Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems
  • Demonstrated Project Management Skills
  • Able to communicate complex, contentious and sensitive information effectively using clear written and spoken English
  • Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services

Desirable

  • Able to prepare and complete documentation accurately with attention to detail, even when under pressure

Knowledge

Essential

  • 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

Desirable

  • Knowledge of JAC computer system.

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.

Employer details

Employer name

St George's Healthcare NHS Foundation Trust

Address

St Georges University Hospitals NHS Foundation Trust

Tooting

SW17 0QT


Employer's website

https://www.stgeorges.nhs.uk/work-with-us/ (Opens in a new tab)

Employer details

Employer name

St George's Healthcare NHS Foundation Trust

Address

St Georges University Hospitals NHS Foundation Trust

Tooting

SW17 0QT


Employer's website

https://www.stgeorges.nhs.uk/work-with-us/ (Opens in a new tab)

Employer contact details

For questions about the job, contact:

Senior QA Specialist

Helen Arnold

helen.arnold@stgeorges.nhs.uk

02087252412

Details

Date posted

16 August 2023

Pay scheme

Agenda for change

Band

Band 7

Salary

£51,488 to £57,802 a year Per annum including inner london HCAS

Contract

Permanent

Working pattern

Full-time

Reference number

200-551187-DK-Z

Job locations

St Georges University Hospitals NHS Foundation Trust

Tooting

SW17 0QT


Supporting documents

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