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D. Production/Aseptic Services Specialist

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Role description

(AfC band 6 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. Coordinate technical staff
  2. Technical screening/aseptic verification
  3. Product Approval (S10 units) - upon completion of accreditation

Training & Staff Management

  1. Coordinate training programme and deliver training to teams
  2. HR duties of Line management, including recruitment & selection & performance issues
  3. Manage staff rotas

Compliance & Quality Management

  1. Maintain the PQS (or ePQS)/PQS processes, including performing investigations of deviations
  2. Support on the maintenance of KPIs, capacity tracking and management of errors/error trending
  3. Troubleshoot stock management activities/issues of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods and falsified medicines assessment
  4. Approve orders
  5. Facilitate internal audits
  6. Authors and reviews operational documentation
  7. Contribute to compliance of PPM programme
  8. Approve temperature alarms
  9. Approve new product requests
  10. Supervise validation activities

Troubleshooting & Problem-Solving

  1. Manage stock management activities/issues of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods and falsified medicines assessment
  2. Monitor and troubleshoot process, product, and performance of all production software/equipment, carrying out investigations to assess the quality, effectiveness, and economy of aseptic services, and plan and implement any changes to the service as a result

Project Management & Improvement Initiatives

  1. Operational management and oversight of a particular speciality (E&T/Operations/Clinical Trials) or line of work (SACT CIVAS, PN, specific production line) → bigger organisations
  2. Day-to-day operational management and oversight of a unit/team → smaller organisations
  3. Implement and manage change / new systems

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)
  • Significant experience in pharmacy technical services
  • Experience in supervision of staff
  • Experience in/supporting line management
  • Qualification/significant experience relevant to specialism they are applying to (i.e. education supervisor, stock management, clinical trials)
  • Leader Academy programmes i.e. Edward Jenner or Level 3 in Management & Leadership / equivalent programme – desirable

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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