Lead Quality Assurance Officer

University Hospital Southampton NHS FT; Southampton; On-site; GBP 52,000 - 65,000; Full time

Benefits offered by this job

NHS discounts

35 days holiday pro rata

Generous pension scheme

Job summary

University Hospital Southampton NHS Foundation Trust is seeking a Lead Quality Assurance Officer to join the Pharmacy Quality Assurance team. This permanent role focuses on maintaining the QMS, GMP compliance, and patient safety within aseptic services.

You will lead QA activities, review documentation, and collaborate with cross-functional teams to ensure medicines are released to patients safely and efficiently, including weekend and on-call rotas as required.

Qualifications

• Undergraduate degree or equivalent GMP QA/QC experience.
• Experience in GMP for sterile medicines.

Responsibilities

• Act as designated Releasing Officer within aseptic service for final QA review and release of compounded products.
• Assess production documentation and quality data to ensure standards before release.
• Investigate and escalate quality concerns; work with production and pharmacy team to ensure safe, timely medicines.

Skills

Analytical thinking

Attention to detail

Change management

Collaborative approach

Communication

Time management

Problem solving

Risk management

General IT skills

Education

Undergraduate degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences

Registered Pharmacy Technician in UK by GPhC

Registered Science Technician (Apt – Level 3 Diploma) in UK

Tools

Microsoft Office

Job description

Job Overview

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Job Title: Lead Quality Assurance Officer. Contract Type: Permanent.

This is an exciting opportunity to join our Pharmacy Quality Assurance team as a Lead Quality Assurance Officer. We are looking for someone who is passionate about quality, compliance, and continuous improvement. Thrives in a fast-paced, highly regulated environment where your expertise directly contributes to patient safety and service excellence.

In this key role, you will help ensure that the Quality Management System (QMS) supporting our pharmacy aseptic services remains effective, compliant, and continuously improving. Your work will play a vital role in maintaining the highest standards of quality, safety, and efficacy for medicines supplied to patients, while supporting compliance with Good Manufacturing Practice (GMP), licensing requirements, and accreditation standards.

Working for our organisation

As one of the largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated ‘Good’ by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for staff recommending the hospital as a place to work or receive care.

We support flexible working and will consider requests taking into account the needs of the service. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme.

Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 30% lower than London and 17 schools rated outstanding by Ofsted.

We believe that using technology wisely shows strong time management and commitment to innovation. However, personalising your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.

Detailed Job Description And Main Responsibilities

In this role you will act as a designated Releasing Officer; you will hold a key responsibility within the aseptic service, undertaking the final quality assurance review and release of compounded products for use. Using your knowledge of GMP, aseptic processing, environmental monitoring, validation, and quality systems, you will assess production documentation and quality data to ensure products meet all required standards before release. You will make critical decisions relating to product quality, investigate and elevate concerns where necessary, and work closely with production and the wider pharmacy team to ensure medicines are supplied safely, effectively and in a timely manner. This highly accountable role places you at the forefront of safeguarding patient safety and maintaining regulatory compliance across the service.

We are looking for a motivated and organised individual with experience of Quality Assurance and GMP environments with excellent communication skills. You will be confident managing competing priorities, investigating quality issues, developing staff, and building effective working relationships with stakeholders at all levels.

This role offers the chance to further develop your leadership and specialist quality assurance skills within a supportive and progressive team dedicated to delivering outstanding patient care. Participation in weekend, bank holiday, and on-call rotas will be required as part of the service.

If you are committed to quality excellence and want to play a pivotal role in supporting safe, high-quality aseptic services, we would love to hear from you.

Qualifications, Knowledge And Experience

• Undergraduate degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or equivalent level of experience of GMP Quality Assurance / Quality Control.) OR Registered Pharmacy Technician in UK by GPhC OR Registered Science Technician (Apprenticeship Standard – Level 3 Diploma in the Principles of Aseptic Pharmaceuticals Processing) in UK by the Science Council
• Experience in supervising teams and ensuring high standards of performance and workflow
• Ability to work under accurately under pressure to meet deadlines while maintaining required standards.
• Experience in Good Manufacturing Practice (GMP) in relation to the production of sterile medicines
• Experience of developing and implementing Standard Operating Procedures (SOPs) and policies
• Demonstrates times when able to work effectively under pressure
• Ability to use a range of information technology programmes effectively including Microsoft office programmes
• Good organisational skills and effective time management with the ability to prioritise workload appropriately
• Ability to use initiative, but know their own limitations and professional boundaries
• Ability to work independently and as part of a multidisciplinary team
• Strong accurate communication skills in English, both verbally and in writing.
• Maintaining continuous professional development requirements or training portfolio
• Work weekends, late nights and bank holidays as per rota
• Cover flexible working hours according to rota

Desirable criteria

• Detailed knowledge of Quality Assurance and Quality Management Systems including relevant experience of audits, validation requirements, investigations, including microbiological, deviations and complaints and change management
• Experience in preparing and presenting at meetings.

Skills and competencies

Essential criteria

• Ability to learn and assimilate information quickly
• Analytical thinking
• Attention to detail
• Change management
• Collaborative approach
• Communication
• Logical thinking
• Organisational skills
• Time management
• Problem solving
• Prioritisation
• Risk management
• Self-motivated
• General IT skills

Trust Values

• Patients First
• Always Improving
• Working Together