QA Officer

  • Kings College London
  • Greater London, UK
  • Sep 15, 2021
Full time Biology/Biotechnology/Life Sciences

Job Description

Job description
The new cyclotron and PET Radiochemistry facility (the PERL) at KCL/NHS Trust St Thomas' Campus, London has the following remit: 1) production of GMP radiotracers for research and clinical use; 2) the discovery and development of new radiochemistries, labelling methodologies and 3) implementation of new PET radiotracers.  
 
This is a key role within the PERL QA team. The post holder will have responsibility for acting as one of the QA Officers for the PERL. QA duties will focus on being a key point of contact between QA and the PERL radiochemistry team whilst undertaking QA tasks in support of the PERL. 
 
This post will be offered on an indefinite basis 
This is a full-time post

Key responsibilities

  • Act as a point of contact between PERL QA and the PET radiochemistry team. 
  • Support the Head of PERL  in maintaining the PERL facility and supporting GMP documentation in an MHRA audit ready state. Provide document control for Standard Operating Procedures, Batch Manufacturing Records and Validation protocols.
  • Undertake regular review of logs for Micro, Physical and Cleaning Records of the PERL.
  • Assist with the preparation and review of manufacturing and validation documentation such as Production and QC batch manufacturing records.
  • Act as a QA reviewer and approver for manufacturing/validation documentation, OCC, Dev, CC, CAPA and production records
  • Attend internal and external QA audits.
  • Support the hosting of external audits
  • Ensure that the data for the QRM review of OCC, Dev, CC, CAPA, Audit actions/findings, document control/review, training records, EM review, Trending and Maintenance log review is documented and available at the time of the QRM.
  • Support PERL management quality awareness by bring to their attention significant trends and issues via periodic reporting.
  • Identify and assess any non-compliance issues, raise issues with senior/line management and ensure appropriate actions are agreed, implemented and followed up. Be proactive to ensure that regulatory and compliance issues are resolved in a timely manner and do not present barriers to the production of radiotracers.
  • Act as a source of advice and guidance on GMP, regulatory and compliance related issues. Support GMP training.
  • Be proactive in providing quality support for the implementation of new radiopharmaceuticals to the PERL.
  • The post holder will be required to work with minimum supervision. They must be able to manage their own time and workload efficiently and effectively. This also requires a confidential and methodical approach with a flexible and adaptable work ethic. They will interlink with other areas of the PET Centre and research groups within the School of Biomedical Engineering & Imaging Sciences and will be required to communicate with them effectively.

 
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.  
 
Skills, knowledge, and experience 
 
Essential criteria 

 
1.       Education: Higher degree (e.g. MSc/PhD or equivalent) in chemistry, pharmacy or related discipline or significant relevant experience 
2.       Knowledge and application of GMP, GCP, QA and current pharmaceutical legislation 
3.       Demonstrated ability to manage quality exceptions and knowledge and application of a pharmaceutical quality system 
4.       Experience working in QA in a licensed pharmaceutical production unit 
5.       Experience of aseptic production processes 
6.       Training and mentorship skills 
7.       Excellent verbal & written communication skills including ability to draft documents e.g. SOPs 
8.       Able to handle several projects at once and prioritise including ability to act on personal initiative and take responsibility for own work and ensuring projects are completed 
9.       Experience of working to targets and deadlines 
10.   Ability to work on own initiative and in a multi-disciplinary team 
11.   Flexible approach to hours & duties and ability to work with a variety of people 
12.   Positive constructive and team-based approach to problem solving 
 
Desirable criteria 
 
1.       Good knowledge of validation including cleaning validation, method validation and CSV 
2.       Trained auditor, with experience of supplier audits 
3.       Knowledge of PET and/or SPECT radiotracer synthesis and QC within a Radiochemistry laboratory experience 
4.       Supervisory experience 
5.       Experience with automated synthesis equipment 
 
Further information
 
 
This post is subject to Occupational Health clearance.

Application Details

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