To manage and perform day to day QA activities at Cell
Medica UK based sites. Contribute to the on-going development of the Cell
Medica Pharmaceutical Quality Management System as directed by the VP Quality.
To specifically provide Quality support to manufacturing
operations based within the Cell and Gene Therapy Catapult GMP manufacturing
centre. The role will be primarily based at Stevenage (~75%) but also at other
Cell Medica sites in London (~25%).
To provide Quality support to a team, manufacturing T-cell therapy products for clinical use. The job responsibilities include Quality support to ensure compliant GMP manufacturing and testing of cell formulations, process development work for new clinical trial products and review and approval of documents including batch records, SOPs and validation/qualification plans and reports. The opportunity to be trained as a QP for AT(I)MP’s may be possible for the right candidate.
In addition to provide some general quality support to
R&D activities and clinical laboratory testing to GCLP, based at Royal Free
Hospital in London and for quality related clinical operations under GCP.
To manage the process of importation, release by the QP and
onward shipping to clinical sites in the US of clinical trial material from
Cell Medica Inc in the US.
up and ensure Cell Medica activities conform with the requirements of both
Quality Management Systems managed by Catapult and Cell Medica
and manage the UK QMS
- Perform routine QA duties to ensure manufacturing, testing and clinical trials activities comply with GMP, GCLP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MP's including;
control system for UK controlled documentation
and preventative actions (CAPA)
& OOS reporting
and recall handling
qualification including external audits as necessary
record review prior to QP release
review and approve Quality and GxP related documentation
- Manage Product Specification Files for ATIMP’s
the Cell Medica manufacturing and R&D teams on Quality related issues
the import, release by the QP and dispatch of clinical trial material imported
from the US
the effectiveness of the quality management systems for UK
VP Quality and Senior Management of significant quality related matters or
risks that could impact product quality, product release or regulatory
quality culture with local team
training of UK site personnel and deliver basic GMP training
in any Quality related issue on other Cell Medica sites globally
Education and Experience
degree in a biological science, pharmacy, chemistry or equivalent
years experience working in a GMP environment or equivalent experience (in
particular small scale e.g. clinical trials or manufacturing individualised
years experience working in a Quality related environment or equivalent
- Experience of writing and/or review of GxP documents (SOP’s, qualification/ validation reports and batch records) to ensure good documentation practice and essential GxP, Quality and regulatory requirements are met
good working knowledge of EU GMP
good working knowledge of cleanrooms, aseptic technique and hygienic
requirements for sterile products
working knowledge of using Microsoft office programs
- A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
of QC techniques applicable to cellular products
of monitoring the effectiveness of Quality Management Systems
of electronic Quality Management Systems
understanding of GCP, GCLP, GDP and HTA requirements
of training staff
to assess risks and recommend pragmatic actions to control them
interpersonal and communication skills (written and verbal)
of managing a wide range of tasks with minimal direction and prioritising tasks
self-motivated and able to motivate others
manner, open minded, honest
The job posting may be closed early if we receive a
high volume of appropriate CVs so please apply at your earliest convenience.
job description is subject to change at any time.
The personal data you provide in your application and as
part of the recruitment process will only be held and processed for the purpose
of the selection process and in connection with any subsequent employment or
placement, unless otherwise indicated. Your data will be retained only for as
long as is permitted by UK legislation and then destroyed.
Unsuccessful applicant data will be held within the
recruitment system for a period of no longer than two years before being
Please be aware that Cell Medica uses a third party supplier to hold the information you submit. The third party company complies with General Data Protection Regulation and Cell Medica’s security policy and therefore will not share your data with anyone other than Cell Medica. In the event of your application resulting in an offer and your acceptance of a position at Cell Medica, your personal information will be transferred to our employee database held by the same third party supplier and also transferred to Cell Medica’s electronic Personnel files.
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