(AfC band 8a equivalent)

Main Duties / Responsibilities:

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 Supervision

1. Accountable*2 for the service delivery and operational management
2. Oversee procurement activities and manage contracts (SLA/TA)
3. Oversee the system for quarantine/release of unlicensed medicines, particularly procured ready-toadminister product

Training & Staff Management

1. Deliver training and education as a subject matter expert (i.e. to peers)
2. HR duties of Line management of management staff, including recruitment & selection & performance issues

Compliance & Quality Management

1. Supervise the safety and effectiveness of the overall service, evaluating and prioritising services when constraints occur, and liaising and negotiating with internal and external stakeholders to maximise production
2. Develop the PQS (or ePQS)/PQS processes, such as review and approval of data trends and highlevel documentation
3. Be a formal contact for the MHRA inspectors and auditors and to put in place effective corrective and preventative actions (CAPA) in response to the inspection

Troubleshooting & Problem-Solving

• (No specific tasks listed in this category)

Project Management & Improvement Initiatives

1. Assist in governance and strategic planning of the service(s)
2. Develop business cases for service improvements and expansion and budget management - reports, trending and authorised signatory
3. Accountable for monitoring and review of the Capacity and Contingency Plans for Pharmacy Technical Services
4. Contribute to review, set targets, and amend KPI's
5. Responsible for service developments/improvement projects, including new equipment/technology
6. Conduct research activities within the department and support research activities within the organisation
7. Responsible for change management in complex situations
8. Integrate organisation-wide, regional, and national work groups as a stakeholder

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, HCPC)*2
• Minimum of PTQA diploma or equivalent qualification / experience
• Extensive experience technical services
• Significant experience in supervision & line management
• Experience in service management
• Experience in supporting service improvement
• Experience in supporting PQS development
• Leadership / project management certification / equivalent
• Experience as an Education Supervisor (depending on scope of role)

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 The current regulatory requirements for Section 10 Aseptic Services Units mandate Accountable Persons to be registered professional with GPhC.