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E. Advanced Production/Aseptic Services Specialist

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Role description

(AfC band 7 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 Supervision

  1. Manage technical staff
  2. Manage and ensure compliance in quarantine/release of unlicensed medicines, particularly procured ready-to-administer product

Training & Staff Management

  1. Delivery of training to stakeholders on specialised subjects
  2. Lead the training and professional development of staff, trainees, and students, anticipating and planning for changes in the service particularly with regards to manpower and training requirements
  3. HR duties of Line management of senior staff, including recruitment & selection & performance issues

Compliance & Quality Management

  1. Lead on the maintenance of KPIs, capacity tracking and management of errors/error trending
  2. Support the development of the PQS (or ePQS)/PQS processes, including ownership of quality management processes (i.e. accountable for the delivery of actions)
  3. Approve change control requests
  4. Approve documentation
  5. Develop internal audit action plan
  6. Facilitate external audits
  7. Supervise validation activities

Troubleshooting & Problem-Solving

  1. Oversee 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. Manage and contribute to the strategic planning of tasks
  2. Key member in service development/improvement projects, including new equipment/technology, and developing new products and processes using Quality Risk Management (QRM) and Quality by Design (QBD) principles
  3. Monitor and review the Capacity and Contingency Plans for Pharmacy Technical Services
  4. Support research activities within the department
  5. Integrate organisation-wide and regional work groups as a stakeholder

Qualifications

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)
  • Minimum of PTQA certificate (foundations) or equivalent qualification / experience
  • Significant experience technical services
  • Experience in supervision of staff & line management
  • Experience in supporting service management
  • Leadership / project management certification
  • Qualification/extensive experience relevant to specialism they are applying to (i.e. education supervisor, stock management, clinical trials)

Related case studies for this role

Further information

Considerations:

  • Level of qualification required for these roles may vary according to the specialism the role in supervising/leading or the technology they work with (i.e. gassing isolators, robots, compounders, etc.).

*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.

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