(AfC band 5 equivalent)

Main Duties / Responsibilities / Characteristics:

The following apply either to all workstreams if a small Section 10 unit (e.g. anti-cancer therapy + CIVAS) or to a specific workstream if a large Section 10 unit or licensed workstream (e.g. parenteral nutrition only)*1

Cleanroom & Production

1. Supervise within cleanrooms and preparative tech services, which may involve aseptic product preparation, supporting troubleshooting of production software/equipment (Medcura®, sterilisation equipment, compounding robots, etc)
2. Ensure GMP compliance of production team and remaining staff within the cleanroom/production environment, against GMP, GDP, COSHH, IR(ME)R, IRR, H&S, HMR, and any other relevant statutory requirements, as applicable
3. Supervise quarantine/release of unlicensed medicines, particularly procured ready-to-administer products
4. Review facility/equipment parameters and conditions for production (i.e., temperature readings, pressure differentials, etc.)
5. Workflow coordination
6. Batch production accuracy checks - for licensed units*2

Training & Staff Management

1. Delivery of training and mentoring to new staff
2. Day-to-day management of junior staff, which may include line management responsibilities

Compliance & Quality Management

1. Supervise management activities of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods, and falsified medicines assessment
2. Contribute to the maintenance of the PQS (or ePQS)/PQS processes, such as assisting in investigations of deviations, and other quality management processes
3. Oversee the implementation of change management within the cleanroom
4. Process temperature alarms
5. Contribute to validation activities

Troubleshooting & Problem-Solving

1. Troubleshooting of stock management activities/issues of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods, and falsified medicines assessment

Project Management & Improvement Initiatives

1. Lead on PDP small projects like simple validations or temp mapping – responsibility and full ownership of a task

Requirements for applying to role:

• L3 qualification (Pharmacy or SMT) + significant experience in pharmaceutical preparation activities or relevant BSc/MSc in applied science subject + substantial experience in pharmaceutical preparation activities
• Relevant professional registration (e.g. GPhC, RCP, RSB, RSC)
• Experience in supporting supervision activities
• Level 2 qualification in Leadership and Team Skills or equivalent - desirable
• Train the trainer/practice supervisor training/accreditation - desirable

Considerations:

*1 Alignment of this profile with AfC job profile may be achieved by adjusting AfC Factor 4 (Planning and organisational skills) and Factor 7 (Responsibilities for policy and service development implementation) accordingly.

*2 Accuracy checking at this level seems suitable for workstreams that are licensed and standard (i.e. batch production of well-known products), and under and a robust PQS (e.g. ePQS).