Senior Quality Assurance Officer

Job OverviewUniversity Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.Please see below for the detailed job description of the role.Main duties of the jobAn exciting opportunity has arisen for enthusiastic, highly motivated, detail focussed individuals to join our friendly Quality Assurance team performing essential tasks that support our aseptic manufacturing units. The roles will cover a range QA activities including managing the Pharmacy Quality System, validation, audits and environmental microbiological oversight.This is an exciting opportunity to be part of small Quality Assurance team of highly professional and dedicated staff, with an opportunity to integrate with our larger sterile production teams, with the overall aim to provide an excellent, quality driven service.Working for our organisationUniversity Hospital Southampton is one of England's largest acute teaching Trusts, offering a wide range of learning and development opportunities to support your career aspirations.Located on the south coast with an international airport and direct rail links to London, Southampton offers an ideal setting to live and work, with the New Forest, South Downs and Jurassic Coast.We believe that using technology wisely shows strong time management and commitment to innovation. However, personalizing 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.At UHS we’re committed to providing a flexible working environment where possible. Whether you are balancing family, study, or your wellbeing with your career, we want to support you so you can help our patients.At UHS, we proudly champion individuality, recognizing that outstanding care is only possible with a diverse, inclusive team. We’re committed to creating an anti-racist, anti-discriminatory environment where everyone feels valued, safe, and empowered to make a meaningful impact in our communities. We welcome applicants of all backgrounds, identities, and experiences to join us in building a healthcare community where everyone can belong, thrive, and contribute.Detailed Job Description And Main ResponsibilitiesThe successful applicant will lead and manage the Pharmaceutical Quality Management System (QMS), ensuring compliance with all relevant licensing and regulatory standards, including MHRA Specials manufacture and Section 10 working.You will be responsible for the day-to-day management of the QMS, including change control, deviations and CAPAs, out-of-specification/out-of-trend investigations, internal and external audits, risk assessments, customer and supplier complaints, recalls, and documentation control.As a Senior Quality Assurance Officer, you should be able to demonstrate proficiency in one or more key QA areas, such as overall QMS management, validation, auditing, or environmental microbiology oversight.A keen eye for detail, demonstrable regulatory knowledge and experience, and excellent written and verbal communication skills are essential for this role. When combined with a passion for continuous quality improvement and a proactive approach to managing your own work, these qualities will make you ideally suited to this position.Person specificationTrust ValuesEssential criteriaPatient FirstAlways ImprovingWorking TogetherQualifications, Knowledge And ExperienceEssential criteriaMaster’s degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or equivalent level of experience of GMP Quality Assurance / Quality Control)Experience in Good Manufacturing Practice (GMP) in relation to the production of sterile medicinesExperience of dealing with complex pharmaceutical issues which requires analysing information from a range of sourcesDetailed knowledge of Quality Assurance and Quality Management Systems including relevant experience of audits, validation requirements, investigations, including microbiological, deviations and complaints and change managementExperience of implementing and working with an electronic quality management system (eQMS)Experience of developing and implementing Standard Operating Procedures (SOPs) and policiesExperience in audits, validation, and quality preparation of guidelines & procedures and writing of reportsDesirable criteriaPostgraduate certificate or diploma in relevant field or further education in Pharmacy Technical Services e.g. PTQAExperience in preparing and presenting at meetings