Senior Aseptic Quality Assurance Officer | Walsall Healthcare NHS Trust

The Band 7 Quality Assurance (QA) Officer plays a key role in ensuring the safe, compliant, and effective delivery of aseptic services within Pharmacy. The post holder is responsible for overseeing and managing Good Manufacturing Practice (GMP) activities, ensuring adherence to all relevant legislation, national guidance, and local policies. They will lead the implementation, development, and ongoing maintenance of the Pharmaceutical Quality System (PQS), monitoring its effectiveness across aseptic and cancer services. The role provides expert QA input into the review of aseptic products and processes, supporting continuous quality improvement and maintaining high standards of patient safety. The post holder will act as a senior QA Officer, supporting the delivery of a safe, efficient, and legally compliant aseptic service. Responsibilities include managing deviations, CAPAs, audits, risk assessments, and validation activities, as well as supporting staff training and governance processes., The post holder will support the delivery of a high-quality, safe, and compliant aseptic pharmacy service by leading quality assurance activities, maintaining robust governance systems, and driving continuous improvement across all areas of practice.,

• Lead and maintain the Pharmaceutical Quality System (PQS), ensuring compliance with GMP, legislation, and national guidance, and driving continuous quality improvement
• Oversee investigations, root cause analysis (RCA), CAPA implementation, change control, deviations, complaints, recalls, validation, and quality trend reporting
• Develop and manage the Quality Management Systems (QMS) and contribute to performance monitoring through KPIs
• Provide expert QA advice to Aseptic Services, supporting high standards in product quality, process compliance, and patient safety
• Lead and support deviation management processes, ensuring timely investigation, resolution, and effectiveness of corrective actions
• Support environmental monitoring programmes, data analysis, trend identification, and implementation of improvement plans
• Contribute to validation activities (URS, DQ, IQ, OQ, PQ), Validation Master Plans, and ongoing equipment and process qualification
• Ensure compliance of materials, products, and specifications with GxP standards, including stability assessment and supplier agreements (SLAs/TAs)
• Support audits, self-inspections, and governance activities, and deliver QA/GxP training to staff
• Provide leadership, supervision, and line management, including staff development, recruitment, and performance management
• Undertake ACT (accuracy checking and approval of pre-filled chemotherapy)
• Contribute to operational service delivery, including aseptic preparation, dispensing, and cross-functional duties as needed
• Support safe use of medicines, risk management (including COSHH), and continuous improvement in patient care
• Act as an authorised signatory for relevant financial and HR processes
  
  We are looking for motivated, forward-thinking individuals who are keen to make a difference, drive quality improvement, and contribute to a patient-centred service. In return, you will join a collaborative organisation that values its staff, supports career progression, and encourages continuous learning.
  
  Walsall Healthcare NHS Trust is an integrated Trust and the only provider of NHS acute care in Walsall, serving a population of 284,300, providing inpatient and outpatient services at the Manor Hospital as well as a wide range of services in the community. Walsall Manor houses the full range of district general hospital services under one roof. The £170 million development was completed in 2010 and the continued upgrading of existing areas ensures the Trust now has a state-of-the-art Critical Care Unit, Neonatal Unit, Obstetric Theatre, and Integrated Assessment Unit facilities.
A new Urgent Emergency Care Centre was opened in March 2023. The two-storey development has significantly improved emergency care facilities and capacity and has provided almost 5,000 square metres of additional clinical space.