Lead Quality Assurance Officer

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 escalate 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.

Person specification

Qualifications, Knowledge And Experience

Essential criteria

• 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

Essential criteria

• Patients First
• Always Improving
• Working Together