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Head of Quality Control Full Time

at Cardiff University Cardiff in Cardiff (Published at 13-05-2021)

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Head of Quality Control
Wales Positron Emission Tomography Imaging Centre (PETIC)
Clinical Innovation Hub
School of Medicine
We have a rare and exciting opportunity for an enthusiastic, highly motivated and experienced individual to join our team of experts who produce radiopharmaceuticals to Good Manufacturing Practices (GMP) standards in purpose designed facilities.
As Head of Quality Control, you will be a key member of PETIC?s Senior Management Team and will take the lead to provide professional expertise and guidance in relation to the development and introduction of new techniques in line with PETIC?s strategic plan. You will also play a key role in the qualification and validation of all Radio Tracers and ensure that we have the appropriate processes and procedures in place.
You will be responsible for the GMP Quality Control Laboratory and all of its specialist equipment and will be expected to ensure a safe working environment that complies with the MHRA guidelines.
You will work closely with our Head of Production to manage and motivate a team of Radiopharmaceutical Production Technicians and Quality Control staff and to certify that they are developed and trained in all the relevant disciplines. You will be accountable for release of products in accordance with the principles of Good Manufacturing Practice when required.
You will be responsible for providing professional advice on resolving complex quality issues and be innovated in your thinking to utilise initiative and implement best working practices that meet our regulatory requirements.
You will be encouraged to establish working relationships within the wider Cardiff University group and the GW4 enterprise, as well as other external key stakeholders to achieve PETIC?s overall objectives.
Applicants should have a degree in a relevant science subject and can evidence a substantial knowledge and experience in working with the Pharmaceutical Industry.
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 High performance Liquid Chromatography, Thin Layer Chromatography, Multi-channel Analysis, Endotoxin and pH meters.
For an informal discussion to find out more about this position, please contact Professor Chris Marshall on 02920 748164.
This post is full time (35 hours per week) and fixed term for 1 year to cover maternity leave and is available immediately.
Salary: £42,792 – £49,553 per annum (Grade 7)
Date advert posted: Thursday, 13 May 2021
Closing date: Sunday, 30 May 2021
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, providing advice, guidance and support, and leading projects within this area
Duties and Responsibilities
Key Duties
  • Provide professional advice and guidance on the Wales Research and Diagnostic PET Imaging Centre processes and procedures to internal and external customers that will have institution wide impacts, advising on the impact of the Wales Research and Diagnostic PET Imaging Centre on strategic developments and plans
  • Take responsibility for resolving issues independently within the Wales Research and Diagnostic PET Imaging Centre where they fall within set role objectives, using judgement and creativity to suggest the most appropriate course of action and ensuring complex and conceptual issues and solutions are understood by the audience
  • Plan and deliver projects that have a wide impact on Cardiff University, Wales and GW4 group, managing the operation of project teams as needed, planning, organising and delegating work, monitoring progress and intervening as required
  • Investigate and analysis specific issues within the Wales Research and Diagnostic PET Imaging Centre, creating recommendation reports, supported by advances within the Wales Research and Diagnostic PET Imaging Centre
  • Ensure that the provision of the Wales Research and Diagnostic PET Imaging Centre is delivered to the institution, proactively changing the delivery according to customer requirements, contributing to the development of institution wide standards within the Wales Research and Diagnostic PET Imaging Centre
  • Establish relationships with key contacts to ensure role objectives are meet, developing appropriate communication links with the University?s Schools/Directorates and outside bodies as required
  • Create specific working groups from colleagues across the University to achieve Cardiff University objectives
  • Develop and deliver training within the Wales Research and Diagnostic PET Imaging Centre
  • Undertake a variety of administrative duties to support the department
  • Instruct and guide other employees across the University within the Wales Research and Diagnostic PET Imaging Centre


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 including acting as the Radiation Protection Supervisor and lead for COSSH
  • Perform other duties occasionally which are not included above, but which will be consistent with the role


Detailed Duties Relating to Good Manufacturing Practice (Chapter 2, section 2.8 & 2.9 of Eudralex Volume 4)

  • To approve or reject, as they see fit, starting materials, packaging materials, intermediate, bulk and finished products;
  • To ensure that all necessary testing is carried out and the associated records evaluated
  • To approve specifications, sampling instructions, test methods and other Quality Control procedures;
  • To approve and monitor any contract analysts;
  • To ensure the qualification and maintenance of their department, premises and equipment;
  • To ensure that the appropriate validations are done;
  • To ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need


Continues in the ‘Additional Information’ Section

Person Specification


Essential Criteria
Qualifications and Education
1. Postgraduate/Professional qualification/NVQ 5 or equivalent experience
Knowledge, Skills and Experience
2. Substantial experience of working within the Pharmaceutical industry
3. Able to demonstrate expert professional knowledge within pharmaceutical manufacturing or radiopharmacy, to be recognised as an authority in the field
4. Proven experience in developing new processes and procedures
Customer Service, Communication and Team Working
5. Able to influence senior decisions within pharmaceutical manufacturing or radiopharmacy that have a strategic impact
6. Evidence of ability to explore customers? needs, adapt the service, and set customer expectations
7. Proven ability to develop networks in order to contribute to long term developments
Planning, Analysis and Problem solving
8. Evidence of ability to research and solve expansive problems using initiative and creativity; identify and propose both practical and innovative solution
9. Evidence of demonstrable knowledge of key advances within pharmaceutical manufacturing or radiopharmacy
10. Evidence of ability to undertake and deliver specific projects and supervise short term project teams
Desirable Criteria
11. Experience of working in a Higher Education environment
12. Fluency in Welsh, written and oral
13. Experience in Radiochemistry

Additional Information


Continuation of the Job Description
  • The authorisation of written procedures and other documents, including amendments;
  • The monitoring and control of the manufacturing environment;
  • Plant hygiene;
  • Process validation;
  • Training;
  • The approval and monitoring of suppliers of materials;
  • The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
  • The designation and monitoring of storage conditions for materials and products;
  • The retention of records;
  • The monitoring of compliance with the requirements of Good Manufacturing Practice;
  • The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
  • Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement
  • Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • Ensuring compliance with Eudralex Volume 4 – The Rules Governing Medicinal Products in the European Union or subsequent equivalent legislation.


IMPORTANT: Evidencing Criteria

It is the 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, 11691BR.
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.

Salary Range Min.


42,792

Salary Range Max.


49,553

Job Category


Business / Strategic Management

Grade


Grade 7



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