Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
Our recent successes are driving significant growth. As such, we are looking to recruit a Quality Systems Officer to join our QA team.
Design and provide continuous improvement of Quality Management Systems.
Monitor and produce metrics of GMP compliance with current Quality Management Systems.
Support all aspects of supplier qualification and ongoing risk management.
Provide primary Quality support for all new products, projects and suppliers/service providers.
Carry out internal audits and follow up to promote continuous improvement.
Perform Annual Product Quality Reviews.
Hosting of client and regulatory audits and inspections.
Support and co-ordinate responses to client and regulatory audits and inspections.
Key responsibilities and accountabilities:
Supports the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/ testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations.
Providing direct quality team support during customer and regulatory audits.
Create and maintain a state of readiness in order to satisfy regulatory and client expectations during audits and inspections
Work in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
In depth knowledge of the pharmaceutical industry in terms of regulations and compliance.
Awareness and understanding of Quality Systems in order to support them effectively.
Communicate compliance updates.
Knowledge of the different aspects of the OXB business in order to assist in investigations.
Actively support continuous improvement of Quality Management Systems
Represent Quality in all new projects to ensure quality is built in as early as possible.
Supporting Quality based projects working as part of a multidisciplinary team as required.
Promoting continuous improvement of the Quality Management System
Ensure that the manufacturing and or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
Reports on-going progress with QA activities and Deviations to Head of Quality.
Attend meetings and follow up communications across the Quality Systems team and other departments.
Key skills and requirements:
Good experience working within pharmaceutical QA.
Working knowledge of GMP & Quality related pharmaceutical regulations & standards.
A level or National Certificate in a Science discipline.
Higher National Certificate or Degree in science discipline desirable.
Computer literate (Word, Excel, MS Office).
Solid working knowledge of Validation and Quality Management systems.
Experience of conducting quality based audits, investigations and root cause analysis.
Understanding and experience of Change Control.
Experience of regulatory and or customer /client audits and inspections.
Understanding & experience of GMP and pharmaceutical industry QA requirements.
Experience in document control or records management systems in a regulated environment.
Good interpersonal and communication skills.
Excellent attention to detail.
Good team player, and must also be able to work alone.
Good organisational and time management skills.
Able to prioritise workload, decisive thinker able to work within agreed timescales.
Experience of use of an electronic Document Management system to GMP standards.
Please note that applications will only be reviewed once a CV has been attached and the Questionnaire has been completed.