PSU Deputy Quality Assurance and Technical Lead

Bristol NHS Foundation Trust; West of England; On-site; GBP 60,000 - 80,000; Full time

Job summary

Bristol NHS Foundation Trust is seeking a PSU Deputy Quality Assurance and Technical Lead to coordinate QA activities within the Parenteral Services Unit (PSU). You will ensure GMP/GDP compliance, maintain the QMS, oversee EM and validation programmes, manage investigations and audits, and support continuous improvement of aseptic manufacturing services for cancer and haematology patients.

Reporting to the PSU Quality Assurance and Technical Lead, you will lead quality assurance initiatives,

Qualifications

• Knowledge of GMP, GDP, and ICH Q10.
• Risk assessment and quality risk management skills.
• Excellent communication and presentation skills.
• Ability to influence and collaborate with multidisciplinary teams.
• Statistical analysis and data interpretation skills.
• Methodical approach with attention to detail.

Responsibilities

• Coordinate QA activities within the PSU and ensure GMP/GDP compliance.
• Maintain the Quality Management System (QMS) and oversee Environmental Monitoring and validation programmes.
• Manage quality investigations and audits; support service developments.
• Provide leadership on quality assurance matters and contribute to continuous improvement of aseptic manufacturing services.

Skills

Quality management

GMP/GDP knowledge

Regulatory knowledge

Communication skills

Stakeholder collaboration

Data interpretation

Auditing

Quality risk management

Education

Science degree

Master in QA or related

Tools

QMS software

EM systems

Job description

Job summary

Bristol NHS Foundation Trust

PSU Deputy Quality Assurance and Technical Lead

The closing date is 15 October 2026

The PSU deputy Quality Assurance and Technical Lead is responsible for completing and coordinating quality assurance activities within the Parenteral Services Unit (PSU), ensuring compliance with Good Manufacturing Practice (GMP), regulatory standards, and Trust policies. The post holder will report to the PSU Quality Assurance and Technical Lead and accountable pharmacist.

The post holder will support the safe and effective preparation of aseptic medicines by maintaining the Quality Management System (QMS), overseeing Environmental Monitoring (EM) and validation programmes, managing quality investigations and audits, and supporting service developments.

Working closely with the PSU Quality Lead, pharmacists, pharmacy technicians, technical officers, Estates, Quality Control services and external contractors, the post holder will provide leadership on quality assurance matters and contribute to the continuous improvement of aseptic manufacturing services supporting cancer and haematology patients.

Main duties of the job

• To apply specialist knowledge of quality management systems, GMP, GDP and quality risk management principles.
• To ensure compliance with national pharmaceutical standards (QAAPs) and NHS guidance relating to aseptic preparation.
• To communicate effectively with individuals within Parenteral Service Unit, and other technical service departments across BFT.
• To develop own skills and knowledge and to support in the training and development of other staff.
• Deputising for the PSU Quality Assurance and Technical Lead

About us

Bristol NHS Foundation Trust brings together more than 28,000 staff to deliver over 160 clinical services across thirteen hospital locations, operating from three main sites at Southmead, Bristol city centre and Weston.

With an annual turnover of £2.3 billion, we are now one of the largest NHS trusts in the United Kingdom. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer.

Bristol NHS Foundation Trust values all people as individuals. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application in order to ensure we're meeting our pledge.

Job responsibilities

Refer to Job Description and Person Specification.

The post holder will be required to work within specialist aseptic clean room facilities which we are required to operate under strict regulatory rules. The guidelines covering the operation of these aseptic facilities mean that staff members with certain long term or recurrent medical or health conditions, such as gastrointestinal or skin conditions, can represent a risk of microbial contamination which therefore precludes access to the clean room. For candidates information, our Occupational Health team will carry out an assessment at the stage when conditional offers are made. The assessment will consider whether any candidate would not be able to work in an aseptic facility and/or whether any candidate would be able to work in an aseptic facility with any restrictions or reasonable adjustments.

Person Specification

Education and qualifications

Essential

• Relevant Science degree
• Postgraduate qualification, Masters or equivalent in Quality Assurance or another aspect of pharmacy technical services or related discipline

Desirable

• Registration or eligibility to register with a relevant professional body

Knowledge, skills and abilities

Essential

• Knowledge of regulatory guidance and standards relating to pharmaceutical quality management (e.g. GMP, GDP, and ICH Q10)
• Risk assessment and quality risk management skills
• Excellent communication and presentation skills
• Ability to influence and collaborate with multidisciplinary teams
• Statistical analysis and data interpretation skills
• Methodical approach with good attention to detail

Desirable

• Leadership and staff development skills
• Lead auditor skills
• Knowledge of specific product types e.g. chemotherapy and parenteral nutrition

Experience

Essential

• Experience of quality assurance or quality control
• Experience + examples of deviation management, root cause analysis and CAPA
• Experience + examples of change control and risk management processes
• Experience + examples supporting audits and inspections
• Experience + examples delivering training and presentations to large groups of people, small teams and on a one-to-one basis verbally and in a written format
• Experience within hospital pharmaceutical manufacturing or aseptic services

Desirable

• Experience of licensed manufacturing activities
• Project management or supervisory experience

Personal qualities

Essential

• Highly professional approach
• Strong organisational and prioritisation skills
• Ability to work independently and make decisions
• Collaborative, supportive and respectful team member
• Willing to learn, open to change

Desirable

• Demonstrable leadership and motivational qualities

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Equal opportunities statement

Bristol NHS Foundation Trust is an equal opportunities employer.