(AfC band 3 equivalent)

Main Duties / Responsibilities:

Cleanroom & Production

1. Support day-to-day tasks within cleanrooms and preparative tech services, which may involve sanitisation, and aseptic product preparation (including intrathecal products)
2. Operate under supervision complex and high-cost production software/equipment (Medcura® or other Compounding Management system, Rapid Gassing VHP chambers, pharmaceutical isolators, compounding robots and automation devices, etc), as per GMP
3. Support the preparation of Clinical Trials products
4. Perform tray assembly and respective checks
5. Cleanroom cleaning activities
6. Picking and packing
7. Waste management (correct use of waste streams)
8. Admin tasks
9. Work under the supervision of a section supervisor

Training & Staff Management

1. Contribute to training of junior staff

Compliance & Quality Management

1. Generate worksheet and labels (electronic system)
2. Batch reconciliation (reconciliation of production documentation + labels)
3. Maintain necessary Validations and Competencies
4. Support stock management and distribution activities of high-cost and high-risk medicines, like raising orders, stock checks, stock control, receipt of goods and falsified medicines check
5. Support quarantine/release of unlicensed medicines, particularly procured ready-to-administer products
6. Participate in supporting tasks related to the maintenance of the PQS (or ePQS)/PQS processes, such as completion of forms and error reporting logs
7. Generate worksheet and labels – electronic automatic systems
8. Labelling

Troubleshooting & Problem-Solving

• (No specific tasks in this category)

Project Management & Improvement Initiatives

• (No specific tasks in category)

Requirements for applying to role:

• Ability to understand Basic English (written and spoken) and Maths.
• RQF Level 2 Qualification(s) (for example GCSE grade 4/C or above) in Maths and English (or equivalent) - desirable (≥ 4/C)*
• Level 2 qualification Pharmacy/Pharma related - desirable

Considerations:

• Organisations should support the employee to achieve the required qualifications (e.g. GCSE level 4 equivalent qualification in Maths, English and Science/functional skills if not already held).
• Pre-process checks have been removed from the main duties of the role because pre-process checking is matched against Level 2 skills, so staff would need to complete a relevant L2 qualification before it.

*Effective entry level role into the Production pathway should be an AFC B3 equivalent. However, having AfC B2 roles within organisations may still be appropriate for roles focused on repetitive lower-risk activities or limited scopes of tasks (e.g. storekeeper, licensed overlabelling).