Job summary
We are looking for a suitably experienced pharmaceutical senior production technician to join our chemotherapy aseptic preparation and dispensing team based in Guy's Cancer Centre. The candidate should be an enthusiastic team player who is able to demonstrate excellent organisational & training skills, effective communication, and has an excellent working knowledge of GMP and manufacturing experience of pharmaceuticals.
Strong foundations in GMP practices, preparing PQS documents such as deviations, change controls and CAPA documents is required.
Main duties of the job
The successful candidate will be responsible for:
Supporting the Principal Pharmacy Technicians (Aseptic Services) in the running of the chemotherapy unit and supervising the production operators in the clean room environment.
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- To ensure the safe, efficient and compliant manufacture of a range of pharmaceuticals under section 10 exemption of the Human Medicines Regulations 2012
- Ensure excellent GMP practices are maintained at all times
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- To train junior staff members in aseptic production practices
- To supervise a cohort of pharmacy assistants and production technicians in both preparation and dispensing activities.
- To participate in the aseptic technical verification of screened prescriptions in EPIC
- To manage the workload in both cleanrooms and support areas
- To ensure that effective usage of the raw materials is undertaken and minimise wastage
- To ensure that daily physical monitoring is maintained and QMH courier is organised in a timely manner for daily delivery
- To act as team lead on weekend working
About us
The Chemotherapy Preparation and Dispensing Unit is located at the Guy's Hospital Site and produces a variety of Systemic Anti-Cancer Therapies (SACT) for use within the hospital trust for patients.
A satellite Cancer Centre unit is based at Queen Mary's Hospital (QMH) - Sidcup that offers our cancer patients the opportunity for treatment closer to home.
CPDU works in close collaboration with the Quality Assurance team and other pharmacy aseptic services units in the Trust across sites; licensed and unlicensed units.
Job description
Job responsibilities
As an overview general duties include the following, for full details refer to the JD provided.
- To participate and supervise all technical aspects of aseptic preparation and to ensure products are made to the highest quality, enforced by GMP and QA systems and that they are fit for their intended use.
- To act as a role model to staff working throughout the department.
- To undertake any other reasonable duties as specified by the Principal technician and senior team.
- To assist in recruitment and selection of staff to the Trusts Pharmacy Manufacturing unit and assist in recruitment to the pharmacy as a whole.
- To be the responsible supervisor critical checker within production areas and to undertake when required preparation and dispensing of raw materials and other products.
Job description
Job responsibilities
As an overview general duties include the following, for full details refer to the JD provided.
- To participate and supervise all technical aspects of aseptic preparation and to ensure products are made to the highest quality, enforced by GMP and QA systems and that they are fit for their intended use.
- To act as a role model to staff working throughout the department.
- To undertake any other reasonable duties as specified by the Principal technician and senior team.
- To assist in recruitment and selection of staff to the Trusts Pharmacy Manufacturing unit and assist in recruitment to the pharmacy as a whole.
- To be the responsible supervisor critical checker within production areas and to undertake when required preparation and dispensing of raw materials and other products.
Person Specification
Skills
Essential
- Ability to accurately undertake in-process critical checks
- Good interpersonal, communication, written and oral skills
- Ability to work at an isolator preparing aseptically produced CIVAs, PN and cytotoxic drugs for long periods of time (e.g. 3 hour sessions, usually 2 sessions per day)
- Be familiar with handling and preparing cytotoxic drugs following approved procedures: GMP, COSHH
- Demonstrated ability to work in a busy demand-led service and be able to work under pressure
- Significant post-qualification experience in a GMP-compliant facility, preparing/manufacturing medicines for human use
- Good team member and team leadership
- Ability to prioritise workload effectively
Desirable
- Demonstrated experience of ability to appraise staff and set performance objectives.
Experience
Essential
- Demonstrable understanding of the risks associated with aseptic preparation, particularly of hazardous drugs and how to identify/manage the risks
- Specialist working knowledge of cleanroom, pharmaceutical isolator and laminar air flow technologies
- Supervisory and Training delivery experience
- Knowledge of regulations and legislation relevant to Clinical Trial
Desirable
- Previous evaluated experience of delivering induction and competency based training e.g. Trainer the Trainers or equivalent / NVQ Pharmacy Services Level 3 - optional unit: 12 or equivalent.
- Previous experience of recruitment and selection of staff
Qualification and knowledge
Essential
- NVQ Pharmacy services Level 3 plus accredited underpinning knowledge (BTEC in Pharmaceutical Sciences or equivalent) or equivalent plus Professional registration as a Pharmacy Technician with the General Pharmaceutical Council OR Completion of Science Manufacturing Technician Level 3 apprenticeship OR Academic qualification (at least BSc) related to medicines for Human Use plus substantial experience working in a GMP-compliant facility preparing/manufacturing medicines for Human Use.
Desirable
- Pre and In Process Checking Accreditation (PIPC)
- Product Approval Accreditation Programme (PAAP)
- Accuracy Checking Pharmacy Technician
- Leeds University Aseptic Preparation of Medicines (APDM) short course or equivalent
Person Specification
Skills
Essential
- Ability to accurately undertake in-process critical checks
- Good interpersonal, communication, written and oral skills
- Ability to work at an isolator preparing aseptically produced CIVAs, PN and cytotoxic drugs for long periods of time (e.g. 3 hour sessions, usually 2 sessions per day)
- Be familiar with handling and preparing cytotoxic drugs following approved procedures: GMP, COSHH
- Demonstrated ability to work in a busy demand-led service and be able to work under pressure
- Significant post-qualification experience in a GMP-compliant facility, preparing/manufacturing medicines for human use
- Good team member and team leadership
- Ability to prioritise workload effectively
Desirable
- Demonstrated experience of ability to appraise staff and set performance objectives.
Experience
Essential
- Demonstrable understanding of the risks associated with aseptic preparation, particularly of hazardous drugs and how to identify/manage the risks
- Specialist working knowledge of cleanroom, pharmaceutical isolator and laminar air flow technologies
- Supervisory and Training delivery experience
- Knowledge of regulations and legislation relevant to Clinical Trial
Desirable
- Previous evaluated experience of delivering induction and competency based training e.g. Trainer the Trainers or equivalent / NVQ Pharmacy Services Level 3 - optional unit: 12 or equivalent.
- Previous experience of recruitment and selection of staff
Qualification and knowledge
Essential
- NVQ Pharmacy services Level 3 plus accredited underpinning knowledge (BTEC in Pharmaceutical Sciences or equivalent) or equivalent plus Professional registration as a Pharmacy Technician with the General Pharmaceutical Council OR Completion of Science Manufacturing Technician Level 3 apprenticeship OR Academic qualification (at least BSc) related to medicines for Human Use plus substantial experience working in a GMP-compliant facility preparing/manufacturing medicines for Human Use.
Desirable
- Pre and In Process Checking Accreditation (PIPC)
- Product Approval Accreditation Programme (PAAP)
- Accuracy Checking Pharmacy Technician
- Leeds University Aseptic Preparation of Medicines (APDM) short course or equivalent
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.
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).
Additional information
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.
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).
