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Cardiff University
Cardiff, Wales, United Kingdom
30+ days ago

Description

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: £27,511 - £31,866 per annum (Grade 5)

Date advert posted: Tuesday, 27 July 2021

Closing date: Tuesday, 17 August 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.



Requirements

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.

Job Information

  • Job ID: 57915070
  • Location:
    Cardiff, Wales, United Kingdom
  • Position Title: 11947BR - Quality Assurance Officer
  • Company Name: Cardiff University
  • Area of Biology: Education / Teaching / Administration
  • Job Function: Administrative Services
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Degree
  • Required Travel: None
  • Salary: 27,511.00 - 31,866.00 Pounds Sterling (Yearly Salary)
Education / Teaching / Administration
Cardiff , UK

Cardiff University is one of the UK’s most innovative, ambitious, and successful universities and we recognise that our success depends largely upon the commitment, energy and enthusiasm of our people.

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