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

• Review environmental monitoring results and microbiological quality control data
• Assess out-of-specification (OOS) microbiological results and develop appropriate corrective action plans in collaboration with production teams 

Environmental Monitoring and Equipment Validation

• Develop temperature mapping strategies and plans
• Review and approve the annual environmental monitoring (EM) testing schedule
• Review and approve corrective and preventative actions following EM failures
• Design and approve physical and environmental monitoring programmes, including methodology, frequency, alert and action limits
• Review and approve chemical testing reports and associated quality control data
• Verify equipment performance, ensuring systems (e.g. sterilisation cycles) meet defined acceptance criteria
• Review and approve the annual validation schedule

Testing and Quality Control

• Review and approve chemical testing reports and associated quality control results
• Authorise product release (or rejection) under a Specials Licence, where designated as a Quality Assurance Release Officer

Pharmaceutical Quality System and Quality Management

• Lead and contribute to equipment and process validation activities, including development and approval of User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ)
• Review and assess non-conformance reports, including approval of low-risk deviations
• Review and approve corrective and preventative actions (CAPA)
• Prepare annual validation reports and data trending analyses
• Manage operator and process validations
• Manage the delivery of internal and external training, including the development and approval of training-related documentation (e.g. SOPs, manuals and master documents)
• Undertake complex risk assessments and lead associated investigations
• Develop and maintain specifications for consumables and starting materials
• Assess out-of-specification (OOS) microbiological results and develop appropriate corrective action plans in collaboration with production teams
• Lead and participate in internal audits to ensure compliance with quality standards
• Support external audits and inspections, including preparation and response activities

Training, Supervision and Development

• Deliver training and competency assessments within the quality function
• Manage the delivery of internal and external training, including the development and approval of training-related documentation (e.g. SOPs, manuals and master documents)

Stock and Inventory Management

• Monitor stock management processes for high-cost and high-risk goods, ensuring compliance and addressing issues as required
• Review and develop quality-related technical agreements (TAs) and service level agreements (SLAs)
• Review and approve procurement orders

Customer & Stakeholder Interaction

• Review and approve action plans arising from complaints and quality-related incidents

Operational and Administrative Duties

• Prepare and issue medical gas testing reports in accordance with regulatory and quality requirements
• Manage and oversee microbiological testing schedules to ensure timely and compliant delivery
• Design and approve microbiological monitoring programmes and protocols
• Perform Design Qualification (DQ) against defined User Requirement Specifications (URS)
• Contribute to validation activities for equipment, including development of URS, DQ, Installation Qualification (IQ) and Operational Qualification (OQ) documentation

Medical Gases Pipeline Systems (MGPS)

• Oversee non-routine medical gas testing, including planning, execution, recording and approval of results
• Provide quality assurance oversight of medical gas testing procurement processes
• Generate medical gas testing reports
• Review and approve MGPS-related documentation (SOPs, manuals and master documents)
• Oversee servicing and calibration of medical gas testing equipment, including external providers
• Deliver internal and external training on MGPS processes and requirements

Leadership and Service Management

• Contribute to and support strategic planning within the service, team or functional area
• Act as a key contributor to service development and improvement initiatives, including implementation of new technologies, equipment and processes using Quality Risk Management (QRM) and Quality by Design (QbD) principles
• Monitor and review capacity and contingency plans
• Represent the service within organisational and regional working groups
• Support research and innovation activities within the department
• Undertake line management responsibilities as required

Considerations:

•  The scope of responsibilities may vary depending on organisational size, service configuration, and specialism

^*1 Alignment with AfC profiles may be supported through appropriate weighting of Factor 4 (Planning and Organisational Skills) and Factor 7 (Responsibilities for Policy and Service Development Implementation)