Agenda for Change (AfC) Band 8a equivalent
Pay scales for 2026/27 | NHS Employers

Main Duties and Responsibilities:

The following apply either across all workstreams within smaller Section 10 units (e.g. combined anti-cancer therapy and CIVAS services) or to a specific workstream within larger Section 10 units or licensed services (e.g. parenteral nutrition only).^*1

Microbial Testing and Analysis

• Manage the microbiological monitoring system, ensuring compliance with regulatory standards
• Evaluate and approve microbiological monitoring reports and associated data trends
• Establish and maintain microbiological alert and action limits

Environmental Monitoring and Equipment Validation

• Review and approve temperature mapping strategies and plans
• Evaluate environmental monitoring (EM) data trends and implement service improvements where required
• Review validation documentation for equipment, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ)
• Lead the development of validation documentation for facilities and complex equipment

Testing and Quality Control

• Review and approve analytical method validation reports
• Approve specifications for consumables and starting materials
• Approve operator and process validation activities
• Provide final authorisation for validation, testing and investigation reports

 Pharmaceutical Quality System and Quality Management

• Lead the review, approval and closure of investigations including deviations, CAPA and change controls
• Approve non-conformance reports and associated actions
• Review and approve annual validation reports
• Provide leadership for the development and governance of the Pharmaceutical Quality System (PQS or ePQS) including approval of documentation
• Approve and oversee internal audit programmes and outcomes, including development of audit reports and corresponding corrective action plans
• Approve Control of Substances of Hazardous to Health (COSHH) policies and associated assurance reports
• Review and maintain the Site Master File, ensuring accuracy and compliance with current standards
• Oversee the document control system, ensuring compliance with best practice and relevant legislation
• Develop and implement document control policies and processes
• Lead and manage complex changes to testing programmes and quality systems
• Develop and maintain the Contamination Control Strategy (CCS)
• Act as a formal point of contact for regulatory authorities (e.g. MHRA), ensuring effective implementation of corrective and preventative actions (CAPA) in response to inspections

Training, Supervision and Development

• Oversee internal and external training programmes and approve associated training documentation, including Standard Operating Procedures (SOPs), manuals and masters
• Evaluate the effectiveness of quality control and quality assurance training programmes
• Develop and approve training strategies and documentation for the quality function
• Deliver specialist training and education as a subject matter expert

Stock and Inventory Management

• Provide oversight of stock management activities relating to high-cost and high-risk medicines and materials
• Review and approve procurement orders, including high-value equipment and services (e.g. Planned Preventative Maintenance contracts)
• Review and approve service level agreements (SLAs) and technical agreements (TAs)

 Customer and Stakeholder Interaction

• Liaise with regulatory bodies (e.g. MHRA) regarding defective medicines, including completion of required reporting
• Assess and investigate the clinical impact of defective products, including those already administered
• Engage with external stakeholders and governance groups, including participation in relevant committees (e.g. Medical Gas Committee)

Operational and Administrative Duties

• Lead comprehensive internal audits against professional and regulatory standards
• Develop and maintain standardised documentation templates (e.g. SOP templates, master records, worksheets and labelling templates)
• Approve product-specific documentation, including worksheets and master record sheets
• Design and implement complaints handling and recall procedures

Medical Gases Pipeline Systems (MGPS)

• Provide governance and policy oversight for medical gases services
• Oversee procurement quality assurance processes for medical gas testing
• Provide oversight of medical gas testing programmes and approve associated reports
• Oversee internal and external training on medical gas testing

Leadership and Service Management

• Hold accountability for the delivery and operational management of a defined service, function or team
• Contribute to governance and strategic planning across services
• Develop business cases for service development, expansion and investment, including financial oversight and authorised signatory responsibilities
• Hold accountability for monitoring capacity and contingency plans
• Contribute to the development, review, and refinement of key performance indicators (KPIs)
• Lead and support service development and improvement initiatives, including implementation of new technologies and systems
• Undertake and support research and innovation activities
• Provide line management for management-level staff, including recruitment, performance management and workforce planning
• Represent the service at organisational, regional and national level as a stakeholder