Aseptic Services Manager for Clinical Trials Aseptic Services Unit

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• To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice, as detailed but not limited to those set out in Quality Assurance of Aseptic Preparation Services Handbook.

 ·To provide cost-effective delivery of high quality aseptic pharmaceuticals, which are fit for their intended purpose to patients of the Trust, and other external customers of the service, and are prepared in a safe, efficient and cost effective manner in accordance with departmental SOPs.

 ·    To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service.

 ·         To have a good working knowledge of Quality Assurance of Aseptic Preparation Services handbook requirements and the yellow cover guidance documents from SPS. To work with the Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required.

• To maintain a comprehensive knowledge of national legislation and recommendations from the Department of Health, MHRA, NHS England, the General Pharmaceutical Council and Royal Pharmaceutical Society relating to aseptic preparation and Good Manufacturing Practice.

 ·         To have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products eg NIMPs, physiological compounds given to study subjects.

 ·    To facilitate NHS QA inspections, MHRA, sponsor audits where required, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings.

 ·    To work with the Accountable Pharmacist and Deputy to maintain the Pharmaceutical Quality System (PQS), and ensure staff are working according to the Standard Operating Procedures detailed in the PQS.

 ·     Alongside the Accountable Pharmacist ensure all staff that work in CTAS are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency.

 ·  To ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards.

 ·  To monitor and record internal and external errors/near misses, taking corrective and preventative action if necessary, as part of the Trust’s Incident Monitoring Program.

 ·   To participate as required at local, regional and/or national levels to support the continuation and advancement of Pharmacy Aseptic preparation and associated research. This may require participation at regional Aseptic Service meetings or projects.

 · To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce.

 ·  To be aware of Health and Safety regulations, and how these apply to an aseptic unit; such as, but not limited to manual handling, First Aid, COSHH, Biocidal Products Regulation.

 · To be responsible for accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment.

 ·   To be responsible for ensuring that Drug Alerts received from the Medicines and Healthcare Regulatory Authority (MHRA) are processed and any actions taken within a required time frame.

 ·    To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.