Search

Quality Assurance Officer

NHS aseptic or production services provide controlled environments in which trained staff produce a range of products such as:

• Ready to Administer (RtA) products such as IV antibiotics.
• Systemic Anti-Cancer Treatments (SACT) such as chemotherapy.
• Parenteral Nutrition (PN).
• Cutting-edge treatments for both gene therapy and clinical trials.

Hands typing on a keyboard

What are NHS Technical Services

Technical services within the NHS are made up of the following services:

  • Aseptic Units: Carry out preparation and dispensing of patient-specific sterile medicines, including chemotherapy, parenteral nutrition (PN), central intravenous additive services (CIVAS) and clinical trials.
  • Production / Manufacturing Units: Carry out the manufacture of batches of medicines, including but not limited to chemotherapy, parenteral nutrition (PN) and central intravenous additive services (CIVAS), clinical trials and gene therapy.
  • Radiopharmacy: Carry out manufacturing and supplying radioactive substances used in nuclear medicine.
  • Quality Assurance (QA): Are responsible for ensuring that the final products conform to the appropriate quality. They are responsible for the creation and maintenance of the quality system used within technical services and are involved with the assessment of the quality of unlicensed medicines.
  • Quality Control (QC): Carry out a range of chemical and microbiological tests on medicines and materials to ensure they are safe to use.

Section 10 Aseptic Units vs MS Licenced Production Facilities

NHS facilities are mostly operated via, Section 10 exemption of the Medicines Act 1968 or a Manufactures Specials (MS) licence granted by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Aseptic Units prepare and dispense sterile patient-specific medicines under the supervision of an Accountable Pharmacist.

Production Units manufacture or assemble batches under the responsibility of a Head of Production and a Head of Quality.

You are likely to find the role of a Quality Assurance Officer within both Aseptic and Production units.

What is the Role?

As a Quality Assurance Officer, you will work in within an NHS facility working in either a hospital or a NHS offsite location. You would generally not be expected to work on wards, oncology units or other patient facing areas.

What would you do in the role?

Your role would be embedded within the quality assurance team. You would be responsible for:

  • Providing advice and support to production staff
  • Providing support in the approval and review of documents
  • Compiling quality data and KPI metrics.
  • Carry out the qualification of new and existing equipment.
  • Completing key quality system documents such as change control, deviations, investigations and audits.

Depending on the organisation your role may be split, and you may have to carry out some tasks on behalf of a Releasing Officer (carries out release of products) or a Physical Tester (carries out the testing of the facility).

Products are manufactured within Aseptic and Production Units for several reasons such as:

  • Ensures the quality of the products are fit for purpose.
  • Safe for the nursing teams as some products are hazardous to their health.
  • Reduce the risk of infection in patients.
  • The use of automated and semi-automated technologies can increase the output of products (production only).
  • Products can be manufactured within small-scale batch sizes to realise manufacturing efficiencies.

The Quality Assurance team may consist of Pharmacy Assistants, Manufacturing Operatives, Manufacturing Technicians (including both Pharmacy Technicians and Science Manufacturing Technicians) Pharmacists and Scientists.  They work under the responsibility of the Head of Quality but day to day you will likely be accountable to the QA Manager.

Although your role will likely be office or laboratory based, you may have to work within the cleanrooms on occasions, for activities such as qualification of new isolators. Working within cleanrooms requires staff to wear cleanroom clothing, hair nets, beard nets, gloves and occasionally masks. Staff are not allowed to wear makeup, false nails, false eyelashes, jewellery when working within the cleanrooms to maintain the strictly controlled environment to project the products and patients.

The Quality Assurance team are vital to the running of a facility and is a regulatory requirement by the MHRA. They ensure that the quality of the products is of the highest standard.

If you want to make an impact on patients’ lives but do not want to engage in patient contact this role is for you.

Technical services roles are great for those who like challenge and variety.

Responsibilities

  • Quality Assurance roles may include, carrying out internal audits, update of documentation, review of microbiological results and support with the maintenance of the quality system.
  • Carry out routine and lead on deviations, change controls, impact assessments, and other key quality documents.
  • Supervisory roles may include supervision of staff, training of new and existing staff, maintaining staff training recorded and general day-to-day support for other staff.

Skills

  • Demonstrates an ability to understand the Quality Management System.
  • Demonstrates ability to schedule workload.
  • Demonstrates the ability to follow all procedures accurately, supervise processes, identify deviations and develop appropriate action plans.
  • Demonstrates ability to identify and implement process improvements.
  • Demonstrates the ability to complete documentation accurately with attention to detail.
  • Demonstrates good time management.
  • Demonstrates the ability to complete documentation accurately with attention to detail along with good verbal and written communication skills.
  • Demonstrates the ability to work under pressure and within agreed deadlines.

Salary

A Quality Assurance Officer within the NHS maybe a band 5 or 6 dependant on the organisation.

Band 5: £28,407 – £34,581

Band 6: £35,392 – £42,618

(Based on 2023/2024 pay scales)

There have been occasions whereby someone has started within the NHS at a band 2 level and has reached career grades such as 8D and higher.

More information on the pay, pensions and rewards, can be found on the NHS Employers website.

Working hours

Quality Assurance Officers working in the NHS will generally work 37.5 a week.

The working models of each NHS organisation may vary therefore you may have to work the following models:

  • 9-5 Monday to Friday
  • Shift working
  • 7-day working

Employers

NHS Organisations within Aseptic Units, Production Units and Laboratories.

Similar roles are available outside of the NHS such as Quantum in Durham.

Work experience

Work experience in any area of the NHS would support you to access employment in your future career.

Asking to volunteer at a hospital at an early stage in your career is also of great benefit.

You may be a current production member of staff within a facility and if so, speak with the QA Manager within the facility and request that you shadow a colleague to see what the role entails.

What to expect

Although your role will likely be office or laboratory based you may have to work within the cleanrooms on occasions, for activities such as the qualification of new isolators. Working within cleanrooms requires staff to wear cleanroom clothing, hair nets, beard nets, gloves and occasionally masks. Staff are not allowed to wear makeup, false nails, false eyelashes, jewellery when working within the cleanrooms to maintain the strictly controlled environment to project the products and patients.

An example of an isolator used within Aseptic Units and Production Units – see opposite.

Isolator aseptic system

Career Progression

There are several career opportunities such as:

  • Validation Specialist
  • Senior Releasing Officer
  • Quality Manager
  • Head of Quality

Further training could also be gained in the form of:

  • Level 5 qualification – leadership and management
  • MSc in Pharmacy Technology and Quality Assurance

These qualifications may be required to be eligible for roles such as the Head of Production or Head of Quality.

A full range of roles can be found within the career escalator tool.

Routes to become a QA Officer

To become a QA Officer within the NHS you will likely need to be registered with a relevant professional body such as:

  • General Pharmaceutical Council
    • Pharmacist
    • Pharmacy Technician
  • Academy for Healthcare Science
    • Science Trainee Program (STP) graduate
  • Science Council
    • Science Manufacturing Technician (SMT)

To become a pharmacist, you must have completed a Master’s Pharmacy (MPharm) degree and have completed the one-year foundation training post-qualification.

To become a Pharmacy Technician, you must have completed a two-year accredited pharmacy technician course. This is likely to be in the form of a level 3 apprenticeship.

To become a STP, you must have a 1st or 2:1 in either undergraduate honours degree or an integrated master’s degree, in a pure or applied science subject.

To become a SMT, you must have completed a two-year accredited science manufacturing technician course. This is likely to be in the form of a level 3 apprenticeship.

Useful links