Role

To assist in the
establishment of a new Pharmaceutical Quality System (PQS) required to enable the
compliant manufacture of Advanced Therapeutic Medical Products within the Cell
and Gene Therapy Catapult GMP manufacturing centre

To perform day
to day Quality Assurance related activities at Cell Medica UK based sites. as
directed by the QA Manager, UK and VP Quality. This will include the review,
approval and issuing of documents including batch records, SOPs and
validation/qualification documents, deviations and change controls.

To support the manufacturing
team on quality related issues.

The role will be
primarily based at Stevenage (~75%) but also at other Cell Medica sites in
London (~25%).

Key
Responsibilities


Assist in the development and establishment of
the UK PQS


Perform routine QA duties to ensure manufacturing
and testing activities comply with GMP and other regulatory requirements
relating to manufacture and clinical trials for cellular therapies and
AT(I)MP's including;


document control system for UK controlled
documentation


change controls


corrective and preventative actions (CAPA)


deviation & OOS reporting


calibration and maintenance


qualification & validation


internal audits


vendor qualification


batch record review


Draft, review and approve Quality and GxP related
documentation


To trend and report trends on performance of the
PQS


Inform QA Manager, VP Quality and Senior
Management of significant quality related matters or risks that could impact
product quality, product release or regulatory compliance.


Promote quality culture with local team



Education and Experience

Essential


University degree in a biological science,
chemistry or equivalent


Min 3 years experience working in a GMP
environment (in particular small scale e.g. clinical trials or manufacturing
individualised patient products.)


Min 2 years experience working in a Quality
related environment


Experience of 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


A good working knowledge of EU GMP


A good working knowledge of cleanrooms, aseptic
technique and hygienic requirements for sterile products


English Language skills


Good working knowledge of using Microsoft office
programs

Desirable


A working knowledge of regulatory requirements or
processes that specifically apply for the manufacture and/or testing of cell
therapy products and/or ATMP’s


Experience of electronic Quality Management
Systems


Experience of training staff

Personal
Attributes


High attention to detail


Capable of prioritising workload


Excellent interpersonal and communication skills
(written and verbal)


Highly self-motivated and able to motivate others


Pleasant manner, open minded, honest


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