Job summary
My name is Mark, I am the Head of Pharmaceutical of Quality Assurance atOxford University Hospitals NHS Foundation TrustWe are seeking an enthusiastic and committed individual to join the Oxford University Hospitals NHS Foundation Trust Pharmaceutical Quality Assurance and Quality Control team as Quality Control Technician.
You will be part of a small dedicated team which plays a critical role in supporting GMP, QC and QA activities in Pharmacy, Radiopharmacy, Clinicial Trials and Sterile Services in the Trust
Main duties of the job
The role will primarily involve planning and undertaking Quality Control Testing and Environmental Monitoring, implementing the Validation Master Plan for the department, undertaking microbiological analysis of environmental monitoring samples, producing reports, and assisting Senior QA staff in providing the QA and QC service to service users within and outside of the Trust.
The role will also involve working as part of the manufacturing team in the Licensed Radiopharmacy.
About us
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research.The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.
We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.
These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.
Job description
Job responsibilities
The post holder will form part of a small dedicated Quality service provided to Radiopharmacy; which holds an Manufacturing Specials (MS) Licence and is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA), Clinical Trials Aseptic Unit; which manufactures under an exemption of the Human Medicines Regulations 2012, and provides further Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidance to other sections within the Pharmacy Department at the Oxford University Hospitals NHS Foundation Trust.
Main duties:
- Testing of clean rooms and pharmaceutical isolators(Environmental Monitoring)
- Tesmperature mapping and monitoring
- Process validation and maintenance of VMP
- Processing of microbiological samples
- Data entry, assessment and manipulation
- Reporting of results
- Writing of SOPs
- Self-inspection and audit activities
- Use and maintenance of the pharmaceutical quality system (PQS) - Deviations, CAPA, OOS and Change Processes
Job description
Job responsibilities
The post holder will form part of a small dedicated Quality service provided to Radiopharmacy; which holds an Manufacturing Specials (MS) Licence and is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA), Clinical Trials Aseptic Unit; which manufactures under an exemption of the Human Medicines Regulations 2012, and provides further Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidance to other sections within the Pharmacy Department at the Oxford University Hospitals NHS Foundation Trust.
Main duties:
- Testing of clean rooms and pharmaceutical isolators(Environmental Monitoring)
- Tesmperature mapping and monitoring
- Process validation and maintenance of VMP
- Processing of microbiological samples
- Data entry, assessment and manipulation
- Reporting of results
- Writing of SOPs
- Self-inspection and audit activities
- Use and maintenance of the pharmaceutical quality system (PQS) - Deviations, CAPA, OOS and Change Processes
Person Specification
Education/ Qualifications
Essential
- Educated to degree level or equivalent in relevant subject, e.g. pharmaceutical sciences, microbiology. Or similar scientific subject Or Registered Pharmacy Technician with post qualification experience in GMP environment.
Desirable
- Technical qualification such as postgraduate certificate or diploma in in relevant subject, e.g. Qualification in Pharmaceutical Technology or Quality Assurance, pharmaceutical microbiology, Radiopharmaceuticals or Pharmaceutical Engineering.
Experience
Essential
- oExperience of working in a GMP environment. oExperience of working in a Pharmaceutical Clean Room. oExperience of working in Quality Assurance and a Quality Control laboratory (including experience working with environmental monitoring.) oAble to demonstrate evidence of Continuing Professional Development.
Desirable
- oExperience of working in a Licenced Manufacturing Unit. oExperience of working in Radiopharmacy and the regulations and restrictions associated with this. oExperience of undertaking Environmental Monitoring. oExperience of interpreting microbiological samples.
Skills, Knowledge and Abilities
Essential
- oKnowledge of EU Good Manufacturing Practice and the regulations surrounding pharmaceutical manufacture. oKnowledge of Licensed and Unlicensed Manufacturing requirements. oKnowledge of clean room design and functioning. oLeadership and motivational skills. oPlanning and organisational skills, ability to prioritise demands on service and plan workload oAbility to make decisions oWell organised oGood Time Management skills oProfessional and personal integrity oEvidence of contribution to regional specialist interest groups oExperience of working in a multidisciplinary team oExperience of developing manufacturing protocols for aseptic services oAbility to work in a team as well as autonomously and can delegate authority appropriately oMust demonstrate flexibility in working practices oEnthusiastic and self-motivated oCapable of working under pressure oMust show commitment
Desirable
- oKnowledge of IRR2017, IR(ME)R and Environmental Permitting Regulations. oUnderstanding of Class 7 Dangerous Goods transport requirements. oPrevious involvement in developing a service within pharmacy or QA department. oGood Clinical Practice (GCP) knowledge oPrevious Major Validation Project involvement. oDemonstrable awareness of key drivers for the NHS oDemonstrable awareness of financial pressures/constraints within the NHS
Person Specification
Education/ Qualifications
Essential
- Educated to degree level or equivalent in relevant subject, e.g. pharmaceutical sciences, microbiology. Or similar scientific subject Or Registered Pharmacy Technician with post qualification experience in GMP environment.
Desirable
- Technical qualification such as postgraduate certificate or diploma in in relevant subject, e.g. Qualification in Pharmaceutical Technology or Quality Assurance, pharmaceutical microbiology, Radiopharmaceuticals or Pharmaceutical Engineering.
Experience
Essential
- oExperience of working in a GMP environment. oExperience of working in a Pharmaceutical Clean Room. oExperience of working in Quality Assurance and a Quality Control laboratory (including experience working with environmental monitoring.) oAble to demonstrate evidence of Continuing Professional Development.
Desirable
- oExperience of working in a Licenced Manufacturing Unit. oExperience of working in Radiopharmacy and the regulations and restrictions associated with this. oExperience of undertaking Environmental Monitoring. oExperience of interpreting microbiological samples.
Skills, Knowledge and Abilities
Essential
- oKnowledge of EU Good Manufacturing Practice and the regulations surrounding pharmaceutical manufacture. oKnowledge of Licensed and Unlicensed Manufacturing requirements. oKnowledge of clean room design and functioning. oLeadership and motivational skills. oPlanning and organisational skills, ability to prioritise demands on service and plan workload oAbility to make decisions oWell organised oGood Time Management skills oProfessional and personal integrity oEvidence of contribution to regional specialist interest groups oExperience of working in a multidisciplinary team oExperience of developing manufacturing protocols for aseptic services oAbility to work in a team as well as autonomously and can delegate authority appropriately oMust demonstrate flexibility in working practices oEnthusiastic and self-motivated oCapable of working under pressure oMust show commitment
Desirable
- oKnowledge of IRR2017, IR(ME)R and Environmental Permitting Regulations. oUnderstanding of Class 7 Dangerous Goods transport requirements. oPrevious involvement in developing a service within pharmacy or QA department. oGood Clinical Practice (GCP) knowledge oPrevious Major Validation Project involvement. oDemonstrable awareness of key drivers for the NHS oDemonstrable awareness of financial pressures/constraints within the NHS
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).
Employer details
Employer name
Oxford University Hospitals NHS Foundation Trust
Address
Churchill Hospital
Churchill Hospital, Old Road, Headington, OX3 7LE
OXFORD
OX3 7LE
Employer's website
https://www.ouh.nhs.uk/ (Opens in a new tab)
