Specialist Technical Officer

Job description

Job responsibilities

Aseptic Preparation

To prepare and prioritise cancer chemotherapy and other medicines for injection, using aseptic technique in laminar airflow cabinets or isolator technology, providing all necessary in-process checks, within the clean room environment, isolated from direct supervision.

To work unsupervised if necessary in the preparation of cancer chemotherapy.

To supervise the preparation of aseptically prepared injectable medicines and to complete the cleanroom supervision in pharmacy technical services accreditation provided by pharmacy workforce development southwest.

To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local Trust policy and departmental procedures.

To complete the initial check of cytotoxic and non-cytotoxic injectables and parenteral nutrition, completing the in-house competency assessment and the pharmacy workforce development southwest accredited pre and in process checking accuracy accreditation.

To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice Guidelines.

To complete any environmental monitoring or operator validation tests and to assist in the planning of new and on-going validations of colleagues.

Documentation

To organise and schedule the daily workload, considering capacity within the unit and patient requirements, under the direction of the senior pharmacy technicians.

To prepare the first draft of master product documentation for new products and the first draft of new standard operating procedures under the direction of the senior pharmacy technicians.

To complete, maintain and file all relevant documents, records, and reports.

To participate in the preparation of clinical trials, completing all necessary documentation as described in the study protocol.

To prepare product documentation and labels, with calculations using appropriate software programmes.

Quality Assurance

To organise and schedule the daily workload, considering capacity and the requirements of aseptic unit colleagues, under the direction of the senior pharmacy technicians.

To organise the environmental monitoring schedule to ensure the aseptic unit is working within GMP parameters.

To support the senior pharmacy technician, training with the organisation of routine validation procedures including aseptic material transfer, aseptic changing and aseptic hand-washing techniques.

To accurately read and interpret all microbial plates and samples. To record results and to draw attention to any which fall outside of action levels and other spurious or unusual data. To record results on to various computer programmes.

To manipulate and present environmental data in an orderly and understandable manner. To check that it conforms to pre-determined limits and to notify the Production Services Manager/Deputy and Accountable Pharmacist/Deputy if it does not.

To report any problems or potential problems with the cleanliness or maintenance of clean rooms to the Production Services Manager/Deputy and Accountable Pharmacist/Deputy.

To complete a suitability assessment of unlicensed medicines based on the criteria outlined in the trust unlicensed medicines policy, including obtaining certificates of analysis or conformity from suppliers as required.

To ensure that all settle plates, broth, and other media are incubated for the correct length of time and at the correct temperature, in accordance with GMP guidelines.

To report any problems and issues with the cleanliness or maintenance of the cleanrooms to the senior team and be proactive in managing any remedial works required, through the permit to work system.

To ensure that temperature monitoring for the aseptic unit and associated area is carried out ensuring that all systems, cold stores, fridges, and freezers are working appropriately. To be proactive in managing any temperature excursions and to ensure that the Production Services Manager/Deputy and Accountable Pharmacist/Deputy is informed of any non-compliance issues.

To participate in inter laboratory analysis schemes as appropriate.

Training and Education

• To train and carry out competency assessments of designated aseptic team colleagues under the guidance and with the support of the Senior pharmacy technician for Education and Training
• To support the Senior Pharmacy Technician for Education and Training in the management and oversight of induction, training and personal develop plans of the aseptic services team
• To act as a mentor and appraiser to colleagues working in aseptic services and support them in career progression and with their wellbeing
• To train and mentor colleagues who rotate into aseptic services as part of a training programme, to include pre-registration trainee pharmacy technicians, pre-registration trainee pharmacists, work experience students, university students, and new rotational pharmacists
• To co-operate and participate in any training and development in aseptic services, attending such study days and courses as necessary for service development
• To assist in maintaining staff training records on the Q-Pulse people module and ensure that all staff complete a training programme, that all training competencies are completed correctly, and standard operating procedures are acknowledged as part of staff training

General

• To supervise Assistant Technical Officers, Senior Assistant Technical Officers, and students working within aseptic services
• To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out
• To take part in an on-call duty rota to assist the on-call pharmacist to include, providing information relating to queries, preparation of emergency medicines and preparation of treatments that are unable to be made in advance.

Person Specification

Knowlegde and Experience

Essential

• Good working proven knowledge of current legislation, department of health guidelines and Medicines and Healthcare Regulatory Agency regulations concerning aseptic preparation and manufacture.
• Previous demonstrable experience in aseptic preparation
• Demonstrable practical experience Of Isolator Technology and Laminar Flow cabinets
• Demonstrable understanding of COSHH
• Basic proven knowledge of Good Pharmaceutical Manufacturing Practice and Good Laboratory Practice
• Previous demonstrable experience working as an in process checker in Technical Services.

Desirable

• Proven knowledge of analytical techniques and equipment
• Attendance on Leeds aseptic preparation and dispensing of medicines course (or equivalent).

Qualifications

Essential

• Proven NVQ Level 3 in pharmacy services aseptic elements or equivalent e.g. Science Manufacturing Technician or proven demonstrable experience
• In house competency assessments in areas of specialist work for the assembly, preparation of documentation and preparation of all products

Desirable

• Proven knowledge of Microsoft programmes e.g. word / excel.
• In house / southwest accreditations for pre and in process checking.

Aptitude and abilities

Essential

• Good written and verbal communication skills with ability to demonstrate fluency, clarity and effectiveness.
• Good training skills and ability to supervise other staff.
• Ability to work as an individual or part of a team
• Mathematical ability
• Ability to manage own time effectively to meet deadlines and to prioritise workload.
• Confidence in dealing with others.
• Ability to identify and manage problems.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

University Hospitals Plymouth NHS Trust

Address

Derriford Hospital Plymouth, Pharmacy Dept, Level 5

Derriford

Plymouth

PL6 8DH

Employer's website

https://www.plymouthhospitals.nhs.uk/ (Opens in a new tab)