(AfC band 4 equivalent)

Main Duties / Responsibilities:

Cleanroom & Production

1. Support the supervision of day-to-day tasks within cleanrooms and preparative tech services, which may involve aseptic product preparation, operating production software/equipment (Medcura®, sterilization equipment, compounding robots, etc.), authorizing production processes (i.e. gassing) as per GMP.
2. Model good cleanroom behaviours and practices, and monitor compliance of staff against GMP standards and effectively challenge as needed
3. Awareness of Health & Safety risks associated with clean room working and safe working environment for self and others
4. Prepare Clinical Trials products
5. Quarantine/release of unlicensed medicines, particularly procured ready-to-administer products
6. Perform pre and in-process equipment checks
7. Visual inspection of final products
8. Supervise operator validations

Training & Staff Management

1. Support the delivery of training and mentoring to new staff
2. Support people management/HR functions such as providing constructive feedback to junior staff
3. Effectively delegate tasks to others

Compliance & Quality Management

1. Perform pre and in-process accuracy checks
2. Responsible for stock management activities of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods, and falsified medicines assessment
3. Generate worksheet and labels (manually)
4. Contribute to the maintenance of the PQS (or ePQS)/PQS processes, such as ensuring completion of documentation as required
5. Apply professional personal integrity and honesty and comply with dignity at work and conduct policies
6. Support implementation of change management within the cleanroom

Troubleshooting & Problem-Solving:

1. Escalate personnel and operational issues, particularly with production equipment and support troubleshooting, to senior team

Project Management & Improvement Initiatives:

• (No specific tasks in category)

Requirements for applying to role:

• Well-founded GMP experience and understanding (Level 3 equivalent) in a cleanroom setting or L3 qualification (Pharmacy or SMT) with GMP understanding
• Relevant professional registration – desirable
• PIPC - desirable

Infusions and Special Medicines Workforce Workstream
Standardisation of Roles Task & Finish Group

• Basic Leadership qualification or willing to complete as part of probation period – desirable

Considerations:

• Annex 21 format for staff that don’t hold a L3 qualification? Local Trust decision.
• This is a development post, with the aim of the staff member growing into an effective cleanroom supervisor.
• The name Cleanroom Supervisor may be misleading nowadays, because it’s a role where the supervisor is developed in it.