Quality Assurance Officer

11947BR

School of Medicine

Managerial, Professional and Specialist Staff – MPSS

Advert

Quality Assurance Officer
Wales Positron Emission Tomography Imaging Centre (PETIC)
Clinical Innovation Hub
School of Medicine

We are looking for a new member to join our team of staff producing radiopharmaceuticals to Good Manufacturing Practices (GMP) standards in purpose designed facilities. You will have a responsible role requiring experience in Quality Assurance, ideally within a licensed manufacturing environment within the pharmaceutical industry or the NHS. The post requires strong administrative skills to ensure that all GMP documentation, records and databases are managed correctly and according to regulatory requirements and PETIC procedures. The post-holder should have a ‘can do’ attitude and pro-actively manage their time and prioritise tasks accordingly. 

Applicants should have a degree in a relevant science subject (Pharmacy, Chemistry, Bio-Chemistry/Technology) and/or experience in one of the following:
•    Quality assurance role within the pharmaceutical industry or NHS
•    Understanding and experience of GMP and MHRA regulatory guidelines
•    Experience in Pharmaceutical quality systems including change control, deviations, CAPA, risk management.
•    Experience of Document Management including Good Documentation Practice (experience of electronic document management/LIMS would be an advantage
•    Some practical experience of supplier management, materials management and audit

The Wales Research and Diagnostic PET Imaging Facility is a state-of-the-art PET centre.  Equipment includes an IBA18/9 cyclotron with a range of targets, Gravatom hot cells hosting Synthera, Fastlab and Trasis radiochemistry systems, automated dispensing systems and a fully equipped quality control laboratory with Radio-chromatography equipment, Multi-channel Analysis, Endotoxin and Gas Chromatography. 

If you would like to know more about this position, then please contact Dr Rebekka Hueting (02920 742005 ) or Prof Chris Marshall on 02920 748164

Please be aware that the typical working day will begin from 8am. Flexible working may be required to meet critical deadlines and project timelines.

This post is full time (35 hours per week), available immediately and is open ended.

Salary: £27,924 - £32,344 per annum (Grade 5)

Date advert posted: Wednesday, 22 August 2021

Closing date: Saturday, 9 October 2021

Please be aware that Cardiff University reserves the right to close this vacancy early should sufficient applications be received.

Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age.  In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements.

Job Description

Job Purpose

Support the University within the Wales Research and Diagnostic PET Imaging Centre (PETIC), be a team member of staff producing radiopharmaceuticals to GMP in a licensed facility. The post-holder will perform a range of quality assurance activities for the PETIC Quality system and general operations.  

This is a responsible role requiring experience in Quality Assurance with strong administrative skills to ensure that all documentation, records, and databases are managed correctly and according to regulatory requirements and PETIC procedures. The post holder should have a ‘can do’ attitude and pro-actively manage their time and prioritise tasks accordingly. 

Duties and Responsibilities

Key Duties
•    Provide professional contribution on all aspects of GMP quality assurance within the Wales Research and Diagnostic PET Imaging Centre processes and procedures, both for internal and external customers, but also to managing external suppliers and service providers.
•    Investigate, analyse, report and follow up specific quality issues within the PETIC Pharmaceutical Quality System, administrate quality tasks through to closure/resolution.
•    Ensure that specialist quality assurance support is provided to PETIC GMP Production Staff, act as an advisor to the team in aspects of quality and continuous improvement.
•    Progress and administer specific quality assurance projects to accomplish key quality objectives and key performance indicators to enable continuous quality improvement.
•    Develop and deliver training within the Wales Research and Diagnostic PET Imaging Centre, including assisting with the delivery and administration of the GMP Training programme.
•    Undertake a variety of administrative duties to support the GMP Quality Control and GMP Production departments.
•    Provide quality assurance review as required on a day-to-day basis for the environmental monitoring data for PETIC's radiopharmaceutical production facilities.
•    Assisting with all aspects of the Pharmaceutical Quality System administration within PETIC, both for paper records and within the electronic quality management system (Q-Pulse). Participate in preparation of PQS documentation using Microsoft Word, Excel and Q-Pulse. Providing quality assurance review to ensure documentation is properly controlled in line with PETIC’s document control procedures.
•    Collate, track, and follow up quality processes (non-conformances, CAPA, change control, risk management and associated effectiveness checks) within Q-Pulse. Escalating quality issues to senior personnel.
•    Data input for PQS processes (e.g., environmental monitoring/QC testing), assist with quality assurance review of quality issues (e.g., out of specifications, supplier failures and material faults).
•    Generation, preparation and formatting of quality reports from Q-Pulse. Input and sorting of simple statistical data for trending, filing results from external suppliers and bringing any unexpected results to the attention of the relevant senior personnel.

Job description continued in Additional information section.

Person Specification

Essential Criteria

Qualifications and Education
1.    Degree/NVQ 4 or equivalent Professional membership/experience in a relevant science subject (Pharmacy, Chemistry, Biochemistry or Biotechnology)

Knowledge, Skills and Experience
2.    Prior experience of working within a quality assurance role in a licensed manufacturing environment (MA, MIA(IMP) or MS) within the pharmaceutical industry or the NHS.
3.    Comprehensive understanding and experience of working in accordance with EU GMP and MHRA regulatory guidelines.
4.    Experience in pharmaceutical quality systems procedures including change control, deviations, CAPA and risk management.
5.    Experience of Document Management including Good Documentation Practice (experience of electronic document management/LIMS would be an advantage).
6.    Some practical experience of supplier management, materials management and audit.

Customer Service, Communication and Team Working
7.    Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
8.    Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered.

Planning, Analysis and Problem solving
9.    Evidence of ability to solve expansive problems using initiative and creativity, identifying and proposing practical solutions and resolving problems with range of potential outcomes.
10.    Evidence of demonstrable knowledge of key advances within the quality assurance discipline.

Desirable Criteria 

1.    Postgraduate/Professional qualification.
2.    Experience in quality assurance of aseptic manufacture, including environmental monitoring.
3.    Knowledge of Good Distribution Practice.
4.    Knowledge of Radiopharmaceuticals Manufacture.
5.    Understanding of validation concepts and knowledge of process validation.
6.    Fluency in Welsh, written and oral.

Additional Information

Continuation of Job Description...

•    Support site validation activities.
•    Prepare information for period quality review meetings, including preparation and circulation of reports.
•    Supporting the Head of Quality Control to ensure that the Pharmaceutical Quality System is managed and maintained in accordance with the license and standards as set down in PETIC policies.
•    Assisting the Head of Quality Control with the supplier management. Issuing and reviewing supplier questionnaires, pro-actively liaising and following up with suppliers and service providers to coordinate collection of essential documentation.
•    Support the Head of Quality Control in implementing the facility’s audit programme and help ensure that PETIC inspection is ready at all times. Coordinate and carry out internal site auditing programmes.
•    Provide site cover as part of a rota where required, collecting and recording deliveries according to PETIC procedures.

General Duties
•    Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
•    Abide by University policies on Health and Safety and Equality and Diversity
•    Perform other duties occasionally which are not included above, but which will be consistent with the role

IMPORTANT: Evidencing Criteria

It is School of Medicine's policy to use the person specification as a key tool for short-listing. Candidates should evidence that they meet ALL of the essential criteria as well as, where relevant, the desirable. As part of the application process you will be asked to provide this evidence via a supporting statement.

Please ensure when submitting this document / attaching it to your application profile you name it with the vacancy reference number, in this instance for this post, 11947BR.

If candidates do not provide written evidence of meeting all of the essential criteria then their application will not be progressed. The School of Medicine welcome the submission of CVs to accompany evidence of the job-based criteria.

Job Category

Management & Executive