Senior Quality Assurance Officer – Biotherapeutics Development Unit
Location: Clare Hall, Potters Bar
Contract: Permanent, full time
Salary: Competitive + excellent benefits
Application process: CV and cover letter
Early application is strongly encouraged as we will close the advert once we have a shortlist of candidates to bring forward to interview.
Are you a self-motivated and sharp minded individual with a passion for driving quality assurance principles in an innovative biomanufacturing unit to deliver novel biologics oncology drugs for early phase clinical trials? Are you an experienced quality professional looking for an opportunity to expand your knowledge and develop skills in the rapidly advancing field of new cancer therapies?
We are looking for a driven and self-motivated individual to…
- Provide support to the QA manager in maintaining and developing the QMS
- Follow up on corrective and preventative actions in a timely manner
- Manage a compliant documentation control system
- Perform QA review of quality-controlled documentation including SOPs, BMRs and reports
- Write QA procedures
- Manage the packing and labelling process for final drug products
- Co-ordinate the shipping of final product to the clinical sites
- Perform QA review of validation documentation including mapping of critical storage areas and environmental monitoring
- Lead and perform internal and external audits
- Perform IMP batch reviews that batches have met the requirements of European Clinical Trials Directive (2001/20/EC, Article 13) prior to QP certification
- Provide QA support on projects and make recommendations to project teams on implementing GMP compliant manufacturing processes
To view a full job description please click here.
Research kills cancer. Here at Cancer Research UK, we’re pushing well into the future – developing newer, kinder treatments and getting closer to cures. We are smart, brave and ambitious individuals united by our relentless pursuit of beating cancer sooner.
As a Senior Quality Assurance Officer at the Biotherapeutics Development Unit you will fill an essential role within CR-UK’s Centre for Drug Development; a centre of excellence in early phase cancer drug development of novel therapies. We are expanding our project portfolio with a particular focus on biotherapeutics, increasing the demand on our state of the art biomanufacturing facility.
Join us and help pioneer more tomorrows through your…
- Experience with biologics and/or IMP manufacturing challenges under GMP
- Experience of working within a GMP QA system with experience with deviations, change controls and Out of specifications reports
- Application of quality and scientific knowledge to identify risks
- Excellent communication skills and capability to write effective and clear instructions and reports
- Audit experience beneficial but we are happy to train on this
Our passion, determination and ambition leads us to set ourselves more and more challenging targets, which means you’ll be constantly striving to accelerate delivery of our novel biologics therapies to early phase clinical trials.
If you’re excited by drug development and quality assurance in a dynamic environment, particularly in oncology, CR-UK’s Biotherapeutics Development Unit is a great place to be.
You’ll need the ability to work closely with teams across the various functions in process development, manufacturing and quality control to find solutions in sometimes challenging situations.
If you’re as ambitious as we are, join our collective force and enjoy an excellent career, as we save lives and add years.
Please note we will be shortlisting on an ongoing basis so don’t hesitate to apply.
At CRUK we value diversity and we’re committed to creating an inclusive culture where everyone is able to be themselves and to reach their full potential. We actively encourage applications from people of all backgrounds and cultures and believe that a diverse workforce will help us to beat cancer sooner.
Please note, from October 2019, our head office will be relocating from Islington to a new office space in Stratford, close to the Olympic Park.
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