Main Duties, Responsibilities and Characteristics:

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

Cleanroom and Production

• Supervise activities within cleanrooms and preparative technical services, including aseptic product preparation and supporting troubleshooting of production software and equipment (e.g. Medcura®, sterilisation equipment and compounding robots)
• Ensure compliance with Good Manufacturing Practice (GMP) and other relevant regulatory frameworks including GDP, COSHH, IR(ME)R, IRR, H&S, HMR, as applicable
• Supervise the quarantine and release of unlicensed medicines, particularly externally procured ready-to-administer products
• Monitor and review facility and equipment parameters relevant to production (e.g. temperature and pressure differentials)
• Coordinate workflow to ensure efficient and safe service delivery
• Undertake batch production accuracy checks within licensed units, where applicable^*2

Training and Staff Management

• Delivery training and provide mentoring to new staff
• Undertake day-to-day management of junior staff, including line management responsibilities where appropriate

Compliance and Quality Management

• Supervise stock management activities for high-cost and high-risk medicines, including stock checks, stock control, receipt of goods and falsified medicines assessment
• Contribute to the maintenance of the Pharmacy Quality System (PQS or ePQS), including participation in deviation investigations and other quality management processes
• Oversee the implementation of change management within the cleanroom environment
• Respond to and manage temperature excursions and alarms in line with procedures
• Contribute to validation activities to ensure continued compliance

Troubleshooting and Problem-Solving

• Support the resolution of issues relating to stock management and operational processes for high-cost and high-risk medicines

Project Management and Improvement Initiatives

• Lead small-scale projects as part of personal development plans such as simple validation exercises or temperature mapping activities, taking full responsibility for delivery

• Level 3 qualification in Pharmacy or Science Manufacturing Technician (SMT), with significant experience in pharmaceutical preparation activities; or
• A relevant BSc or MSc in an applied science subject with substantial experience in pharmaceutical preparation activities
• Relevant professional registration (e.g. GPhC, RCP, RSB, RSC)
• Demonstrable experience supporting or undertaking supervisory responsibilities

 Desirable :

• Level 2 qualification in Leadership and Team Skills (or equivalent)
• Training or accreditation in teaching, such as Train the Trainer or Practice Supervisor training

Considerations:

^*1 Alignment of this profile with AfC job profiles may be supported by appropriate weighting of Factor 4 (Planning and Organisational skills) and Factor 7 (Responsibilities for Policy and Service Development Implementation)

^*2 Accuracy checking at this level is most appropriate within licensed, standardised workstreams (e.g. batch production of established products), operating under a robust PQS (e.g. ePQS).