Aseptic Pharmacy Practitioner

The Christie International; Manchester; On-site; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Recruit and Retain payments £2,000 per

Job summary

The Christie NHS Foundation Trust is seeking a skilled Aseptic Practitioner to supervise the aseptic production of clinical trial materials, SACT, EAMS, and gene-therapy injections. The role involves ensuring GMP-compliant operations, accurate syringe handling, and staff supervision in a cleanroom environment.

Applicants should have NVQ/pharmacy qualifications and experience with GMP, HSE standards, and aseptic dispensing; a pathway for career progression within the aseptic team is highlighted

Qualifications

• NVQ Level 2 in Pharmacy Services or equivalent with willingness to complete Aseptic Pharmaceuticals Science Manufacturing Technician Level 3.
• NVQ Level 3/BTEC in Pharmacy Services or equivalent national qualification.
• Aseptic Pharmaceuticals Science Manufacturing Technician Level 3 qualification.

Responsibilities

• Supervise cleanroom staff and workflow.
• Plan, organise and prioritise work activities within clean rooms.
• Ensure all processes and SOPs are followed by staff in ASU.
• Carry out equipment tests, inspections and verifications before/after sessions.
• Manage stock and perform aseptic dispensing and accuracy checks.
• Train junior staff and coordinate daily workload.

Skills

Supervision

Quality Assurance

Communication

Education

NVQ Level 2 in Pharmacy Services

NVQ Level 3/BTEC in Pharmacy Services

Aseptic Pharmaceuticals Science Manufacturing Technician Level 3

Tools

SOPs

GMP experience

Environmental monitoring equipment

Job description

The successful candidate will participate in and supervise the aseptic production of clinical trial, SACT, EAMS, FOC and gene therapy injectable medicines, and will oversee the daily work of aseptic staff during production. If you are interested in the safe manufacture of injectable medicines and would like to develop supervisory skills to support team management, this could be the ideal role for you.
The Aseptic Services Unit at The Christie NHS Foundation Trust is a world leader in phase I clinical trial material, supporting over 100 trials as well as EAMS, FOC and compassionate use schemes. The ideal candidate will have strong concentration skills, the ability to accurately manipulate syringes and needles, and the capability to read syringe volumes precisely.
The role requires the ability to stretch and twist when cleaning facilities and isolators. All work is performed within a clean room environment under the supervision of the Accountable Pharmacist and a highly trained technical team.
This role is eligible for Recruit and Retain payments of £2,000 per annum while the scheme remains in place.

Please note previous application need not apply

Main duties of the job

• Preparation of worksheets and labels for aseptically prepared products
• Setting up work trays for aseptically prepared products
• Sanitisation and transfer of all materials required for production
• Aseptic preparation of injectable materials
• Cleaning of facilities and isolators prior to and post production
• In process checks
• Supervision of junior staff
• Recording and maintaining the correct parameters to allow for aseptic manipulation within the isolators
• Checking of all components and consumables required for safe manipulation of aseptically prepared products (when suitably trained and qualified)
• Taking monitoring samples using TSA and SAB contact and settle plates

Working for our organisation

We are an ever-expanding multi-disciplinary team of Assistants, Practitioners, Technicians, and pharmacists who strive to produce exceptionally high-quality injectable medicines to each patient that uses our service.
The Aseptic team is a diverse and dynamic team who work in a specialised cleanroom environment where teamwork is the key to efficiency and managing the patient experience. Each day is both challenging and rewarding in equal measures, with cancer treatments constantly evolving and new types of drugs being trialled each year.
We are at the forefront of developments in terms of drug innovation and team development, we were one of the first hospitals in the country to introduce the progression role of Aseptic Practitioner to pharmacy and we are looking forward within the next year to being able to add the Science Manufacturing Technician qualification to our already large portfolio of training and staff qualifications here at The Christie
We have recently developed a career pathway for technical staff wishing to progress from band 2 up to band 8a and support all qualifications and in house developments that allow for this progression should you wish to further your career within the pharmacy aseptic team.
So, if you want to work as part of an ever-progressing team and you enjoy a challenge then we could be the team for you.

Detailed job description and main responsibilities

Supervision of cleanroom staff and workflow.

• Plan, organise and prioritise work activities within clean rooms.
• Ensure all processes and procedures are followed by staff operating in the ASU.
• Responsible for the safe use of equipment within clean rooms, ensuring clean room staff use equipment in accordance with instructions and SOPs.
• Ensures that all required functional tests, inspections and verifications are carried out on clean room equipment before and after work sessions.
• Reports equipment faults and deviations and ensures that deviations are authorised and records are diligently completed.

Delivering products and service as part of the Aseptic team

• Experience and knowledge in good manufacturing and processing procedures.
• To be part of the dispensing service for systemic anti-cancer therapy (SACT) requiring aseptic preparation including cytotoxic drugs, gene therapy and monoclonal antibodies from point of prescription receipt.
• To be aware and follow all departmental operating procedures and Good Manufacturing Practice (GMP) guidance at all times.
• To aseptically dispense products within the aseptic facilities including accurately measuring volumes and following aseptic no-touch techniques.
• To be responsible for the transfer disinfection into the aseptic units of all items required for aseptic processing, following departmental processes.
• To be fully aware of the COSHH regulations particularly with regard to the safe storage and handling of pharmaceutical products, to be aware of the Aseptic Spillage procedure and what to do in the event of spillage of a drug product.
• Carry out environmental monitoring with swabs, contact and settle agar plates. To be responsible for sending environmental monitoring samples to Quality Control in a timely manner.
• Provide support to the aseptic administration systems.
• To participate in aseptic unit cleaning rota, including cleaning of the aseptic units before and after core hours, if required. To undertake regular cleaning duties carried out during the working day.
• To set up and assemble work trays according to departmental SOPs in a timely and efficient manner.
• To carry out accuracy checks on assembled work trays, once trained following departmental programme and or PIPC certification.
• To co-ordinate daily workload, managing breaks and highlighting issues of productivity slowing down to a senior technician.
• To ensure adequate knowledge and understanding of clinical trials products prepared in aseptics relevant to the job role including accountability, stock control and storage requirements. To follow Good Clinical Practice (GCP) guidance and undertake where relevant data collection for aseptic clinical trial products.
• To communicate effectively with healthcare professionals both within and outside the Trust. To ensure good team working with other pharmacy staff, ward staff and other service providers as necessary.
• To carry out stock management including receipt, correct storage, stock count, expiry check and weekly ordering of all aseptic items including drugs, diluents and consumables.
• To carry out stock ordering through multiple supply channels and monitor stock levels.
• To be able to participate in the on-call rotation for making ‘out-of-hours’ aseptic SACT if the service demands.
• To train junior members of staff in core areas as deemed appropriate by the Education & Training Lead.
• To contribute to bank holiday working where required.
• Be available and flexible to potential move to seven day working.

Support and maintain the Quality Assurance system

• To be aware of and participate, where required, in departmental audits.
• To assist in the updating and reviewing of SOPs and the building of drugs in the pharmacy computer system.
• To assist with annual and ad-hoc validations.
• Support and assist the Chief Technicians and Highly Specialised Technicians.

Other.

• To perform any other duties as requested by the line manager, Aseptic Services Manager or Director of Pharmacy.

Person specification

Qualifications

• NVQ Level 2 in Pharmacy Services or equivalent/higher nationally recognised qualification with willingness to complete Aseptic Pharmaceuticals Science Manufacturing Technician Level 3.
• NVQ Level 3/BTEC in Pharmacy Services or equivalent nationally recognised qualification.
• Aseptic Pharmaceuticals Science Manufacturing Technician Level 3.

Experience

• Industrial/pharmaceutical or medical work-related background with specific knowledge of GMP/lab-based work experience.
• Knowledge of GMP, clinical trials and hospital aseptic services.

Skills

• Proven skills in organising, supervising and training staff.
• Ability to make adjustments to workflow when the need arises.
• Ability to communicate to staff to extract maximum output with tact and diplomacy.

Knowledge

• Knowledge and the application of Standard Operating Procedures and Quality Assurance systems.
• Good manufacturing, dispensing or distribution practices.
• Knowledge of COSHH.
• Attendance of Quality Assurance training programs.

Values

• Professional.
• Able to work under pressure.
• Extremely flexible and reliable.
• Ability to demonstrate the organisational values and behaviours.

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

Application Information - If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

Sponsorship Information - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship. You can review the list of eligible role and requirements on the government website.

Pre-Employment Checks - To confirm your suitability for the role, we will carry out pre-employment checks in line with NHS Employment Check Standards . These include:

• Identity verification
• Right to work check
• Disclosure and barring service (DBS)/Criminal record check (dependent on role, payment of this will be the applicants responsibility)
• Professional registration and/or qualification check
• Occupational health assessment
• Employment history and reference validation

All applicants external to The Christie NHS Foundation Trust will be required to provide their HMRC employment history to cover the most recent three years employment. This information will used to validate employment history andreferences.

If you require sponsorship, we will assess your eligibility based on current government guidance. If the role is not eligible and you cannot demonstrate your right to work, your conditional offer may be withdrawn.

If You're Offered the Role - you will be agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

No Smoking Policy - You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Additional Information - We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy.

The Christie NHS Foundation Trust is committed to the highest standards of ethical conduct and integrity in all our activities. We have a zero-tolerance approach to modern slavery in any of its forms, including slavery, servitude, forced or compulsory labour, and human trafficking. We are fully committed to acting ethically and with transparency in all our business dealings and relationships, and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our organisation or supply chains.

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Name Laura Bentley Job title Chief Aseptic Pharmacy Research Liaison Technician Email address [e-mail] Telephone number 0161 918 7644