Job summary
An exciting opportunity to join the Quality Assurance team working in Pharmacy Technical Services Unit (PTSU) at the Royal Cornwall Hospital. We are looking to recruit an enthusiastic, motivated individual with experience of Pharmacy Quality Assurance or who can undertake a developmental role where specific training to fulfil the post will be given.
The PTSU is a large, dedicated facility producing chemotherapy, TPN and a range of other aseptic products under section 10 exemption, and radiopharmaceuticals and non-sterile manufacture under an MHRA Specials license, with the possibility of extending this license to other products and services. The PTSU currently produces approximately 2,000 aseptic items a month and 6,500 non-sterile items. The supply service is licensed by the MHRA as a wholesaler.
This is a good opportunity to adopt the perfect work/life balance taking advantage of the surrounding countryside and beaches
Main duties of the job
The role of the Quality Assurance Technician is to:
Assist in the provision of data that demonstrates compliance with GMP and GDP
Undertake the microbiological and physical testing of clean rooms and isolators
On a day to day basis, run the Microbiology QC laboratory processing qc samples, visual identification of organisms and preparation of samples for submission to Clinical Microbiology.
Document creation, amendment and control.
The release to use of pre-packed medicines prepared under the Pharmacy Manufacturing Specials License, under the supervision of the Head of Pharmacy Quality Assurance.
Assist with audits raising non-compliances where GMP/GDP is not met.
About us
Sustainability is integral to the Trust achieving the NHS Net Zero target. All staff are therefore actively encouraged and supported to implement new ways of working within their field of expertise.
Job description
Job responsibilities
Challenges of the role:
Assimilating and processing large amounts of quality control data to ensure accurate decisions are made about the production and release of medicinal products.
To produce consistently reliable and accurate work in a timely manner.
Working Conditions potential exposure to cytotoxic material, radioactive sources and live micro-organisms.
To maintain professional competence and up to date knowledge of GMP and GDP.
Job description
Job responsibilities
Challenges of the role:
Assimilating and processing large amounts of quality control data to ensure accurate decisions are made about the production and release of medicinal products.
To produce consistently reliable and accurate work in a timely manner.
Working Conditions potential exposure to cytotoxic material, radioactive sources and live micro-organisms.
To maintain professional competence and up to date knowledge of GMP and GDP.
Person Specification
Qualifications
Essential
- Degree in Chemistry, Biology, Pharmacy or other related science
Desirable
- Chartership with the relevant professional body
- Evidence of participation in structure learning courses for EU GMP
Experience
Desirable
- Significant experience in Pharmacy Technical Services QC role.
- Evidence of clean room monitoring, microbiological laboratory work, document control
Practical and Intellectual Skills
Essential
- Good all round communication skills both verbal and written
- Able to demonstrate excellent levels of accuracy in all areas of work
- Ability to prioritise work and manage time effectively / meet deadlines
- Ability to work alone as well as part of a team
- Good computer and keyboard skills
Desirable
- Working with Quality Management system software such as QPulse or drug systems software such as JAC
- Working knowledge of excel / ms office
- Experience of PPE
Disposition / Attitude
Essential
- Pleasant personality and able to work effectively as part of the team
- Good all round health
- To be able to concentrate for frequent but short time frames during data processing and releasing of medicines
- To be able to cope with occasional distressing situations when on the wards when collecting data
Training
Essential
- Recent evidence of continuing training and personal development
- Able and willing to undertake additional training to support QC status
Desirable
- Evidence of training & assessing staff
Person Specification
Qualifications
Essential
- Degree in Chemistry, Biology, Pharmacy or other related science
Desirable
- Chartership with the relevant professional body
- Evidence of participation in structure learning courses for EU GMP
Experience
Desirable
- Significant experience in Pharmacy Technical Services QC role.
- Evidence of clean room monitoring, microbiological laboratory work, document control
Practical and Intellectual Skills
Essential
- Good all round communication skills both verbal and written
- Able to demonstrate excellent levels of accuracy in all areas of work
- Ability to prioritise work and manage time effectively / meet deadlines
- Ability to work alone as well as part of a team
- Good computer and keyboard skills
Desirable
- Working with Quality Management system software such as QPulse or drug systems software such as JAC
- Working knowledge of excel / ms office
- Experience of PPE
Disposition / Attitude
Essential
- Pleasant personality and able to work effectively as part of the team
- Good all round health
- To be able to concentrate for frequent but short time frames during data processing and releasing of medicines
- To be able to cope with occasional distressing situations when on the wards when collecting data
Training
Essential
- Recent evidence of continuing training and personal development
- Able and willing to undertake additional training to support QC status
Desirable
- Evidence of training & assessing staff
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).
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