Main Duties and Responsibilities:

Cleanroom and Production

• Support the supervision of day-to-day tasks within cleanrooms and preparative technical services, including aseptic product preparation, operating of production software and equipment (e.g. Medcura®, sterilisation equipment, compounding robots, etc.), authorising production processes (i.e. gassing) as per GMP.
• Demonstrate and promote best practice in cleanroom behaviours, monitor staff compliance with GMP standards and provide appropriate challenge where required
• Maintain awareness of health and safety risks associated with cleanroom working, ensuring a safe working environment for self and others
• Prepare clinical trials products in line with relevant protocols and standards
• Undertake the quarantine and release of unlicensed medicines, particularly externally procured ready-to-administer products
• Perform pre- and in-process equipment checks
• Conduct visual inspection of final products to ensure quality standards are met
• Supervise operator validation activities

Training and Staff Management

• Support the delivery of training and mentoring for new staff
• Contribute to people management activities, including providing constructive feedback to junior staff
• Delegate tasks effectively to appropriate team members

Compliance and Quality Management

• Perform pre- and in-process accuracy checks in line with operational procedures
• Undertake stock management activities for high-cost and high-risk medicines, including stock checks, stock control, receipt of goods and falsified medicines assessment
• Generate worksheets and labels manually, ensuring accuracy and compliance with procedures
• Contribute to the maintenance of the Pharmaceutical Quality System (PQS or ePQS), including ensuring completion of required documentation
• Demonstrate professional personal integrity and adhere to organisational policies, including dignity at work and standards of conduct
• Support the implementation of change management initiatives within the cleanroom environment

Troubleshooting and Problem-Solving:

• Escalate personnel and operational issues, particularly those relating to production equipment and support troubleshooting activities in collaboration with senior staff

Project Management and Improvement Initiatives:

• No specific tasks identified within this category at present

• Demonstrable GMP experience and understanding at Level 3 or equivalent within a cleanroom setting, or a L3 qualification (e.g. Pharmacy or Science Manufacturing Technician) supported by GMP understanding

Desirable:

• Relevant professional registration
• Pre and In Process Checking within Aseptic Services (PIPC)
• Basic Leadership qualification or willingness to achieve this during the probationary period

Considerations:

• The application of Annex 21 for staff who do not hold a Level 3 qualification should be determined locally by the Trust
• This is a developmental post, with the expectation that the individual will progress into an effective cleanroom supervisor over time
• The title ‘Cleanroom Supervisor’ may not fully reflect the developmental aspect of the role, as the supervisory element is developed over time rather than fully established at appointment.