Job summary
This is a new role and an exciting opportunity for the successful candidate to become a vital member of two teams within the Trust.
The post holder will be a member of the Quality Team, which supports manufacturing in accordance with MS and MIA(IMP) licences in Pharmacy and in Radiopharmacy (based in Nuclear Medicine).
The post holder will be named as the Quality Controller for the Radiopharmacy licences.
The post holder is responsible for management and implementation of the QMS in Pharmacy and Radiopharmacy.
The post-holder is responsible for supporting the development of the strategic direction, leadership and the development of Quality Assurance and Quality Control to the Trust, to meet local, regional and nationally agreed requirements and priorities.
The post-holder is required to work to high standards of accuracy, detail and safety, and able to make informed decisions when under pressure and when information is scarce.
Main duties of the job
The post holder would ideally have > 4 years working in Quality Assurance in a licensed Pharmaceutical and / or Radiopharmaceutical manufacturing environment.
The post holder should have significant experience using a variety of Pharmaceutical Quality System and service optimisation tools including those listed below:
The post holder should have expertise in management, development and implementation of continuous improvement strategies, identified through use of quality and risk management tools.
The postholder will release manufactured radiopharmaceutical products & IMPs under regulation 37 Medicines for Human Use (Clinical Trials) Regulations 2004, and support the QP with QA and IMPs for clinical trials.
About us
The Royal Free London NHS Foundation Trust is one of the UK's biggest and most innovative trusts. Across three main hospitals, our dedicated army of staff care for over 1.6million patients, treat more than 200,000 in A&E, deliver over 8,000 babies and carry out more than 17million tests.
Our size, scale and influence offer you unrivalled career opportunities and a forward-thinking approach to working that works around your lifestyle. From flexible hours and generous benefits, to next level training, we make it easier to take your career to the top.
Job description
Job responsibilities
Please see attached job description for more information about this role and working at Royal Free London NHS Foundation Trust.
Job description
Job responsibilities
Please see attached job description for more information about this role and working at Royal Free London NHS Foundation Trust.
Person Specification
Royal Free World Class Values
Essential
- oDemonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Pharmacist or relevant Science degree
Desirable
- Full membership of a relevant Professional Body
- Further qualification in relevant technical or management area
- Mandatory CPD to maintain fitness to practice
- Diploma in Radiopharmacy or Pharmaceutical Technology & Quality Assurance
Experience
Essential
- oProven experience of good performance in previous jobs
- oExtensive experience in pharmaceutical manufacturing, including experience in a licensed facility
- oExperience of managing & motivating staff
- oExperience of training and supervising staff
- oDemonstrated experience & ability to successfully supervise and undertake a range of technical projects
- oDemonstrated expert technical knowledge covering Pharmaceutical QA, Production and / or Radiopharmacy
- oKnowledge of all aspects of cGMP, and current legislation and regulations and ability to apply this knowledge to support QA services
- oDemonstrated knowledge of principals and practices of aseptics / parenteral products e.g. formulation, stability, administration, legal issues
- oKnowledge of COSHH, health and safety at work
- oAn understanding of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
- oDemonstrated knowledge of cGMP, G(QC)LP and PQS
- oDemonstrated knowledge of Validation requirements of (Radio)pharmaceutical facilities and Audit
- oDemonstrated knowledge of Pharmaceutical microbiology and Contamination Control
- Eligible to act as an authorised releasing officer
- Experience in a MHRA Licensed Pharmacy Manufacturing Unit and / or Radiopharmacy
- oExperience of service provision management
Desirable
- oPrevious experience in the design, development and undertaking of stability studies
- oPrevious experience in validation of pharmaceutical / Radiopharmaceutical manufacturing processes
- oKnowledge of IRMER, ARSAC and radiation safety requirements
- oExperience in developing new clinical services and novel products.
- oExperience in clinical trial activities.
skills and aptitudes
Essential
- oDemonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
- oDemonstrated expert technical knowledge of G(QC)LP and GMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems
- oDemonstrated Project Management Skills
- oDemonstrated ability to manage out of specification results and incidents and develop and review action plans to resolve these
- oAble to communicate effectively with all healthcare professionals and colleagues orally and in writing.
- oAble to identify and manage risk
- oAble to solve difficult and ambiguous problems by advanced reasoning and sound technical judgement
- oAble to deliver and validate staff training
- oAble to manage non compliances and incidents and develop and review action plans to resolve them
- oAble to prepare and complete documentation accurately with attention to detail, even when under pressure
- oAble to work effectively in stressful situations
- oDemonstrated ability to perform complex calculations accurately
- oAble to plan, prioritise and organise self
- oAble to plan, prioritise and organise the work of others
- oAble to meet deadlines
- oAble to work unsupervised
- oIT skills including use of email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes
- oDemonstrated effective customer service skills
- oGood team worker
- oDemonstrated ability to deliver lectures, workshops and formal presentations
- oCritical Appraisal skills
- oAble to follow local Manual Handling procedures
- oDemonstrated evidence of the safe handling of hazardous materials
Other
Essential
- oExcellent verbal and written communication and presentation skills suitable for a range of audiences.
- oExperienced in giving presentations to diverse audiences.
- oAble to act as an Ambassador for the Service
- oAble to perform the duties of the post with any aids and adaptations
- oRequired to wear specialised clean room clothing and safety equipment
- oEffective time management
- oEffective team worker
- oPositive approach & a 'can-do' attitude
- oAble to work on own initiative, be innovative and develop the role
Person Specification
Royal Free World Class Values
Essential
- oDemonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Pharmacist or relevant Science degree
Desirable
- Full membership of a relevant Professional Body
- Further qualification in relevant technical or management area
- Mandatory CPD to maintain fitness to practice
- Diploma in Radiopharmacy or Pharmaceutical Technology & Quality Assurance
Experience
Essential
- oProven experience of good performance in previous jobs
- oExtensive experience in pharmaceutical manufacturing, including experience in a licensed facility
- oExperience of managing & motivating staff
- oExperience of training and supervising staff
- oDemonstrated experience & ability to successfully supervise and undertake a range of technical projects
- oDemonstrated expert technical knowledge covering Pharmaceutical QA, Production and / or Radiopharmacy
- oKnowledge of all aspects of cGMP, and current legislation and regulations and ability to apply this knowledge to support QA services
- oDemonstrated knowledge of principals and practices of aseptics / parenteral products e.g. formulation, stability, administration, legal issues
- oKnowledge of COSHH, health and safety at work
- oAn understanding of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
- oDemonstrated knowledge of cGMP, G(QC)LP and PQS
- oDemonstrated knowledge of Validation requirements of (Radio)pharmaceutical facilities and Audit
- oDemonstrated knowledge of Pharmaceutical microbiology and Contamination Control
- Eligible to act as an authorised releasing officer
- Experience in a MHRA Licensed Pharmacy Manufacturing Unit and / or Radiopharmacy
- oExperience of service provision management
Desirable
- oPrevious experience in the design, development and undertaking of stability studies
- oPrevious experience in validation of pharmaceutical / Radiopharmaceutical manufacturing processes
- oKnowledge of IRMER, ARSAC and radiation safety requirements
- oExperience in developing new clinical services and novel products.
- oExperience in clinical trial activities.
skills and aptitudes
Essential
- oDemonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
- oDemonstrated expert technical knowledge of G(QC)LP and GMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems
- oDemonstrated Project Management Skills
- oDemonstrated ability to manage out of specification results and incidents and develop and review action plans to resolve these
- oAble to communicate effectively with all healthcare professionals and colleagues orally and in writing.
- oAble to identify and manage risk
- oAble to solve difficult and ambiguous problems by advanced reasoning and sound technical judgement
- oAble to deliver and validate staff training
- oAble to manage non compliances and incidents and develop and review action plans to resolve them
- oAble to prepare and complete documentation accurately with attention to detail, even when under pressure
- oAble to work effectively in stressful situations
- oDemonstrated ability to perform complex calculations accurately
- oAble to plan, prioritise and organise self
- oAble to plan, prioritise and organise the work of others
- oAble to meet deadlines
- oAble to work unsupervised
- oIT skills including use of email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes
- oDemonstrated effective customer service skills
- oGood team worker
- oDemonstrated ability to deliver lectures, workshops and formal presentations
- oCritical Appraisal skills
- oAble to follow local Manual Handling procedures
- oDemonstrated evidence of the safe handling of hazardous materials
Other
Essential
- oExcellent verbal and written communication and presentation skills suitable for a range of audiences.
- oExperienced in giving presentations to diverse audiences.
- oAble to act as an Ambassador for the Service
- oAble to perform the duties of the post with any aids and adaptations
- oRequired to wear specialised clean room clothing and safety equipment
- oEffective time management
- oEffective team worker
- oPositive approach & a 'can-do' attitude
- oAble to work on own initiative, be innovative and develop the role
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
