Requisition ID: 25916
Location:
Newcastle, GB
Contract Type: Open Ended
Working Pattern: Full Time
Posted Date: 15 Aug 2023
Salary: £33,966 to £36,024 with progression to £44,263 per annum
Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.
Closing Date: 05 September 2023
The Role
We have an exciting opportunity for a Senior Quality Control Technician to join the PET Tracer Production Unit (PTPU) within the University’s Imaging Hub. The PTPU is completing the redevelopment in its Good Manufacturing Practice (GMP) facilities with a view to producing PET radiopharmaceuticals that will enable the University to begin clinical diagnostic imaging.
In this role, you’ll be based at our Newcastle Upon Tyne campus that has fantastic transport links and state of the art facilities. Within the first 6 months of your role, there will be some flexibility around working from home, but thereafter, the role will be based onsite full-time.
The successful candidate will join the PTPU technical team as the lead for Quality Control (QC) activities within the facility. You will be responsible for qualification and maintenance of QC equipment, analytical method development, analytical method validation, stability studies and routine QC testing for finished products and starting materials.
This role will take the team size to 3, with a view to growing it 5 in the near future. With growth, brings opportunity, and once you’ve had time to settle into the role, you’ll have the opportunity to manage the technician we have in the team currently as well as a second technician we plan to hire. The team will be working on delivering clinical grade radiotracers for exciting projects in the detection and quantification of Lewy Body Dementia and Parkinson’s Disease.
We are an organisation that champions collaboration and, in this role, you’ll be working closely with production technicians and contribute to their method development activities as well as any applicable Quality Control activities required by the regulatory authorities (i.e., MHRA). The PTPU is working with Newcastle Upon Tyne Hospitals (NUTH) Pharmacy directorate and so you’ll also be working closely with the NHS to ensure compliance in everything we do in PTPU.
You will report to Dr Stephen Hobson who has been in his position for almost 6 years, and you will also be able to rely on our QA Manager (NUTH) on matters of GMP for support and guidance.
The successful candidate will need to have a degree in a relevant subject, experience & knowledge of leading QC GMP activities and relevant experience in an operational laboratory. You must also be confident in working with a high degree of independence and as part of a team.
Additionally, you’ll need excellent time management and communication skills together with a willingness to learn new techniques and approaches.
To apply for the position, we’ll need your CV and a personal statement outlining how you are suitable for the role using evidence to highlight how you meet the essential criteria in the knowledge, skills and experience as listed in the job description.
This role is open ended with a 3 year review.
For informal enquiries please contact Dr Stephen Hobson via email (Stephen.hobson@ncl.ac.uk)
Vacancy details can be found at http://www.ncl.ac.uk/vacancies/jobs/. Applications must be made on-line through the e-recruitment system.
Further information about Imaging at Newcastle University can be found via the following link: http://www.ncl.ac.uk/civi/about/
Key Accountabilities
Quality Control and Quality Assurance
• Manage the specification requirements, and procurement of new equipment in QC and the resultant installation and qualification
• Lead the design, preparation, and implementation of Quality Control procedures
• Be the Subject Matter Expert in ensuring PTPU QC compliance with the UK Medicines Authority: MHRA, including UK-GMP, ICH and PIC/S guidelines
• To keep up to date with the latest changes and modifications to MHRA guidelines concerning QC of radiopharmaceuticals (i.e., cGMP)
• Work closely with Production and Quality Assurance Managers to ensure compliance for the facility.
• Lead and manage/supervise the QC testing activities that are carried out in the Quality Control Laboratory.
• Prepare QC documentation: QC worksheets, SOPs, Forms, Policies Reference standard BMRs required for use in PTPU
• Supervise PET Tracer Quality Control following batch manufacture, to include the supervision of other PTPU staff in the QC department to ensure service delivery of the tracers to patients.
• Using expert knowledge, prepare and deliver training relevant to QC activities in the PTPU.
• Ensure the correct storage and management of reference and retention samples.
• Manage, conduct, and record testing schedules for incoming goods, raw materials and appropriate re-tests as required.
• Working closely with Quality Assurance Manager contribute to Supplier approval processes
• Oversee the ongoing qualification, calibration, and maintenance of equipment in the QC department.
• Ensure adherence of 3rd party service personnel to schemes of work and other PTPU policies (i.e., Permits to work, Monitoring of Outsourced Activities and risk assessments), while they are onsite in the QC laboratory.
• Coordinate and supervise outsourced activities pertaining to operations in the QC dept (including contract testing labs).
• Prepare and manage Quality Technical Agreements for 3rd party suppliers for QC services and where relevant for the facility
• Document processes and analytical results to a standard appropriate to the production of PET tracers intended for administration to patients and volunteers
• Perform Out-of-specification investigations in compliance with MHRA guidance, with the QA Manager
• Lead analysis of PTPU analytical results, using appropriate statistical tools, to highlight trends in data
• Contribute to self-inspection programme to promote continuous improvement and compliance to UK-GMP
• Manage the QC laboratory annual budget request
• Complete and contribute to PTPU Pharmaceutical Quality System, including deviations, change controls, investigations and CAPAs.
• Act as a Document Controller as per documentation control policy
• Lead QC processes for new product introduction including:
o setting specifications in-line with the British Pharmacopoeia,
o reference standards,
o analytical method development,
o analytical method validation (as per ICH-Q2)
o process validation tests.
• Plan and lead tracer stability programmes (as per ICH-Q1)
Production
The post holder will primarily focus on Quality Control, but in order to maintain resilience within the facility, the post holder must hold a working knowledge of Production Operations.
• Be proficient in any of the technical roles required on a manufacturing day.
• Be proficient in the operation of production equipment for the production and labelling of radiopharmaceutical for patient use.
• Assist with overall operation, maintenance, and monitoring of the PET radiochemistry facility, that may include monitoring of temperature, pressure and flow gauges, arranging for service or repair as appropriate
• Review Production Standard Operating Procedure (SOP) documents, Risk Assessments and COSHH forms for Production
• Review Qualification & Validation documentation for Production equipment and processes
Facility
• Contribute to strategy and ongoing development needs for the PTPU, including contribute to and/or prepare Policy documentation
• Facilitate safe visits for maintenance or other works and for visits by staff or members of the public where that is feasible
• To act as the Quality Control representative during MHRA inspections and internal PTPU audits
• Act as Training Coordinator for PTPU personnel
• Preparation of QC dept costing documents for PTPU budgets and new PET tracer cost enquiries
• Lead in the implementation and qualification of computerised systems across the PTPU, including adhering to MHRA data integrity requirements
• Remain up to date with industry developments & techniques – via manufacturer, vendor and academic literature that may benefit the PTPU facility
Health and Safety & Radiation Safety
• Perform role of deputy Radiation Protection Supervisor including contribution to and implementation of Local Radiation Rules and Health & Safety Policies
• Perform role of Deputy Health & Safety Officer
• Prepare Radiation Risk Assessments and COSHH assessment for use in the QC laboratory.
• Proactive role in facility H&S management, including documentation review and updates
• Maintain records related to input and output of open and sealed radiation sources (utilizing University’s Isotope Stock Inventory System where appropriate), personal radiation dosimetry and area contamination monitoring
• With the University Radiation Protection Officers & Radiation Protection Supervisors be proactive in how H&S is managed within the PTPU, contributing to the overall safe culture in the unit.
• Contribute to a positive health & safety culture in the PTPU
The Person
Knowledge, Skills and Experience
Knowledge
• Up-to-date knowledge of modern analytical techniques e.g., HPLC, GC, TLC
• General QC laboratory skills (e.g., in the use of pipettes, volumetric flasks, balances)
• Up-to-date Good Manufacturing Practice (GMP) and Good Quality Control Laboratory Practice (GQCLP) knowledge
• Knowledge of GMP QC equipment qualification & maintenance, analytical method development, analytical method validation, QC testing of starting materials and finished products and stability studies i.e., British Pharmacopoeia (BP), EU-GMP Chapter 6 and Annex 15 and ICH-Q1 and ICH-Q2.
• Computing skills and experience with standard Microsoft Office software for Word processing, preparing presentations and using spreadsheets etc.
• Ability to learn the use of and operate specialist software packages
Desirable
• Knowledge in a specialist radiochemical QC environment using dose calibrators, radio-TLC, radio-HPLC and gamma spectrometry
• Knowledge of Pharmaceutical Quality Systems (PQS) as they relate to QC activities e.g., change control, deviations, Corrective Actions Preventative Actions (CAPA), Out-of-specification (OOS) investigations
• Knowledge of computerised system validations and data integrity requirements e.g., EU-GMP Annex 11 and MHRA Data Integrity Guidance
• Use of automated or semi-automated chemical synthesis equipment
Experience
• Relevant demonstratable laboratory experience in a GMP Quality control environment
• Experience of working in a laboratory-based environment, preferably a QC/radiochemistry laboratory
• Qualification, operation, and maintenance of analytical equipment including HPLC, GC and TLC
• Experience of testing of GMP materials (i.e., starting materials and finished products) GMP / GQCLP and BP requirements.
• Experience in working to SOPs
• Experience in writing SOPs, Risk Assessments, and COSHH forms
Desirable
• Experience in radiopharmacy QC environment using dose calibrators, radio-TLC, radio-HPLC and gamma spectrometry
• Experience of QC microbiology testing e.g., Bacterial Endotoxins, Sterility
• Experience in leading / managing a QC laboratory environment
• Experience of training other staff members in QC activities
• Experience in analytical method validation (ICH-Q2), stability studies (ICH-Q1)
• Experience developing and writing new QC procedures for regulatory or similar purposes
• Experience in analytical method development and specifications requirements for introducing new GMP products
• Experience of managing / coordinating outsourced activities e.g., equipment calibration / maintenance / re-qualification
• Experience in statistical analysis of analytical data
• Experience of using PQS as they relate to QC activities e.g., change control, deviations, CAPA, OOS investigations, self-inspections, Quality Technical Agreements
• Experience of working to MHRA standards and representing QC in MHRA / external audits.
• Experienced laboratory Health and Safety lead
• Experience in working with both sealed and open sources of ionising radiation
• Experience in providing radiation protection supervision (evidence of training)
• Experience in working with radioactivity
• Experience in the use of automated or semi-automated equipment and processes
• Ordering supplies using an on-line ordering system to maintain adequate stocks of materials essential to QC / production requirements
• Experience of managing QC lab budgets and/or developing new product introduction costings.
Skills and Abilities
• Excellent communication skills – written and oral
• Leadership Skills and decision-making skills
• Enthusiastic
• The ability to train /mentor others
• Adaptability, high degree of technical competence, ability to multi-task to meet all facility needs.
• Must be a strong self-starter who can work independently, but also cooperatively within a team setting
• Good organisation and time management skills, with the ability to prioritise tasks
• Team-player
• IT Skills
• Operation of specialised equipment, requiring specialist training
• The performance of routine and highly complex tasks utilizing demanding and potentially hazardous techniques
• Be flexible regarding working hours as samples may need to be processed outside normal working hours – within university guidelines
• Conscientious, reliable, flexible, and willing to adapt
• You must be willing to identify and undertake training as required in coordination with management team.
Desirable
• High attention-to-detail
• Evidence of continuing professional development (CPD)
• Desire for learning and continuous improvement to improve department standards
• Ability to inspire and influence others
• Ability to deal with high pressure situations
Qualifications
• An hons degree in a relevant subject such as Chemistry, Chemical Engineering, Pharmacology or Biochemistry
Desirable
• Qualification / Post-Grad Course in Pharmaceutical GMP
• Qualification Radiopharmacy / Radiochemistry
• Qualification in Pharmaceutical Analysis / Analytical Chemistry / Microbiology
• Member of a Joint Professional Body (RSC, RPS, RSB).
Newcastle University is a global University where everyone is treated with dignity and respect. As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.
We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.
At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality. We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education REC.
In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Requisition ID: 25916
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