Senior Assistant Technical Officer – Pharmacy Aseptics Quality Control

Integrated Care System; Plymouth; On-site; GBP 26,000 - 32,000; Full time

Job summary

A health service provider is seeking a Senior Assistant Technical Officer in Pharmacy Aseptics Quality Control to support the pharmacy aseptic unit. The candidate must possess strong knowledge in environmental microbiology and experience in aseptic or quality assurance roles. This full-time position includes responsibilities such as environmental monitoring, compliance with Good Manufacturing Practice, and mentoring staff. A vibrant work environment is offered in Plymouth, UK.

Qualifications

• Strong understanding of COSHH and health and safety legislation.
• Experience in an aseptic environment.
• Good written and oral communication skills.

Responsibilities

• Coordinate the routine environmental monitoring of the aseptic suite.
• Record environmental data into various computer systems accurately.
• Supervise and train aseptic and QC personnel.

Skills

Knowledge of Good Manufacturing and Laboratory Practice

Proven knowledge of environmental microbiology

Ability to input and interpret data into Microsoft Excel

Confidence in dealing with others

Education

5 GCSEs grade C/4 or above in English, Maths and 3 other subjects

NVQ level 2 in Pharmacy Services

Job description

Senior Assistant Technical Officer – Pharmacy Aseptics Quality Control

An exciting opportunity has arisen for an enthusiastic and self-motivated band 3 Assistant Technical Officer to work in our Pharmacy Quality Control department at University Hospitals Plymouth NHS Trust. To undertake quality duties to support the pharmacy aseptic unit. You will need to have:

• Good proven knowledge of environmental microbiology
• Demonstrable experience in an aseptic or a quality assurance/control environment
• Proven understanding of COSHH and health and safety legislation
• Good proven knowledge of Good Pharmaceutical Manufacturing and Laboratory

***Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***

Main duties of the job

To coordinate and complete the routine environmental monitoring of the aseptic suite and the radio-pharmacy department. Coordinate the routine validation of aseptic operatives and ensure that processes are completed in good time against a defined schedule. Accurately incubate, read and interpret microbial plates, samples and validations. Record the results and draw attention to results outside of action levels and other spurious or unusual data. To record environmental data into a variety of computer systems. To inform and liaise with the aseptic team about outstanding validations and cleaning requirements, ensuring compliance with Good Manufacturing Practice.To follow safe and efficient systems of work in accordance with relevant legislation e.g., Good Manufacturing Practice, Good Laboratory Practice,Control of Substances Hazardous to Health and Standard OperatingProcedures. Ensure that temperature monitoring is carried out, and that temperature monitoring system and cold stores, refrigerators and freezers are working appropriately. To ensure that non-compliance issues are escalated appropriately to the lead technicians/deputy. To obtain certificates of analysis from product suppliers for purchased raw materials, consumable items and unlicensed medicines. To complete pre-release checks and approve for use or otherwise raw materials, consumables, components and previously received unlicensed medicines.Please see attached job description for a full list of duties.

About us

We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure.

If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on 01752 432100.

We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams.

It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.

Job responsibilities

• To coordinate the organisation and complete the routine environmental monitoring of the aseptic suite and the Radiopharmacy department, including settle plates, surface sampling, active microbial sampling, air flow measurements and air particle monitoring.
• To coordinate the routine validation of all aseptic operatives and ensure that all processes are completed in good time against a defined schedule.
• To accurately incubate, read and interpret all microbial plates, samples and validations. To record the result and draw attention to results outside of action levels and other spurious or unusual data.
• To record environmental data into a variety of computer systems with a high degree of accuracy.
• To inform and liaise with the aseptic team about outstanding validations and cleaning requirements, to ensure compliance with Good Manufacturing Practice.
• To follow safe and efficient systems of work in accordance with relevant legislation e.g., Good Manufacturing Practice, Good Laboratory Practice, Control of Substances Hazardous to Health and Standard Operating Procedures
• To complete personal operator validations in order to work in the aseptic suite.
• To line manage the rotational aseptic/QC ATOs on a day-to-day basis, allocating duties according to service needs.
• To mentor and be responsible for conducting individual performance reviews in liaison with the senior technicians for Assistant Technical Officers to ensure continued professional development
• To supervise, train and complete competency assessments of aseptic and QC personnel under the supervision of the training technician
• Undertake annual appraisals of aseptic/QC ATOs
• To ensure that temperature monitoring across the department is carried out, ensuring that the temperature monitoring system and all cold stores, refrigerators and freezers are working appropriately. To ensure that any non-compliance issues are escalated appropriately to the lead technicians/deputy.
• Assist the quality assurance specialist technical officer with temperature mapping across the pharmacy department.
• To obtain certificates of analysis from product suppliers for purchased raw materials, consumable items and unlicensed medicines.
• To complete pre-release checks and approve for use or otherwise raw materials, consumables, components and previously received unlicensed medicines based on in-house specifications and in accordance with procedures.
• To carry out routine housekeeping duties within Quality Control, to include stock checks, stock rotation and expiry date checks.
• To report and be responsible for raising a permit to work form for any maintenance issues within the aseptic and surrounding areas.
• To be responsible for the dispatch, monitoring and reading of samples sent out to external laboratories for testing
• To complete, maintain and file all relevant, documents and reports
• Prepare laboratory reagents and label them in accordance with GLP and COSHH
• To prepare master documentation such as product specifications and standard operating procedures under the supervision of the senior technicians
• To partner the senior technicians in the recruitment and selection process for Assistant Technical Officers
• To assist in the induction and training of new members of staff under the supervision of the training technician.
• To assist with stock control to include performing rolling stock checks, expiry date checking, removal of expired stock and investigation of discrepancies
• Assist in dealing with enquiries from wards, e.g., regarding medicines which have been subjected to temperature excursions or defective medicines
• Undertake general housekeeping duties including defrosting refrigerators and freezers, cleaning the laboratory and surrounding areas and equipment, as necessary.
• To report all errors and near misses using the aseptic error reporting scheme
• To participate in weekend, bank holiday and late-night rotas as required.
• To participate in annual personal appraisal process
• To attend such study days and updating courses when necessary.
• To undertake any other reasonable duties deemed necessary by the Director of Pharmacy.

For further details please see attached JD&PS

Person Specification

Knowledge and Experience

• Proven knowledge of Good Manufacturing and Laboratory Practice
• Proven knowledge of environmental microbiology
• Demonstrable experience of inputting and interpreting data into Microsoft Excel and Access
• Proven knowledge of COSHH and health and safety legislation
• Previous demonstrable experience in an aseptic environment
• Familiar with laboratory and environmental equipment

Qualifications

• 5 GCSEs grade C/ 4 or above in English, Maths and 3 other subjects. Or equivalent demonstrable experience in a pharmacy aseptic/ quality assurance/control environment
• NVQ level 2 in Pharmacy Services or equivalent demonstrable experience

Aptitude and Abilities

• Good written and oral communication skills
• Ability to prioritise workload and to self-motivate
• Confidence in dealing with others

Attitude and Motivation

• Ability to use own initiative and take personal responsibility
• Able to maintain high level of accuracy within a busy, high-pressure environment
• Ability to work evenings, weekends and bank holidays on rota
• Comfortable handling hazardous substances including cytotoxic drugs, chemical and biological hazards
• Willingness to wear specialist cleanroom clothing

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.

Contract

Permanent

Working pattern

Full-time

Reference number

216-AM-C7234518

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